Deborah Manzi-Smith, MD and Charles C. Coddington III, MD

Introduction

As all medical specialties evolve, so has obstetrics and gynecology. Procedures that were formally exclusively performed in the hospital setting are now exclusively performed in the office setting. Some office procedures (i.e. endometrial biopsy, transvaginal ultrasound/saline infusion sonography) have decreased the number of hospital surgical procedures that a physician needs to perform to make a diagnosis. Additionally, now there are medical therapies utilized that routinely replace surgical therapies (i.e. methotrexate for ectopic pregnancies). All these changes have resulted in shifting care from the hospital setting to the medical office. These changes in the specialty of Obstetrics and Gynecology coupled with the recent demands placed on the medical community for cost control has helped spark the trend in the development of more outpatient oriented care and office surgical suites. Although the technology to perform minor gynecologic surgical procedures in an office setting has been available for years most "simple" gynecologic procedures are still performed in the hospital setting. This chapter will discuss the preparation and briefly review a number of minor procedures, which can be performed in an office surgical suite.

Preparing the facility

Although many procedures can be performed in an office setting, the particular layout, room sizes, equipment availability and staffing issues may make it difficult for the practitioner to perform certain office surgical procedures. The facility should at a minimum, allow for easy access of wheelchairs and stretchers. Additionally, the basic medical supplies needed would include pulse oximeters, basic airway management equipment, EKG monitoring, intubation supplies, rooms equipped with call alarm buttons, intravenous line stands, a crash cart and sharp waste containers. An electronic table capable of trendelenburg, with cushioned knee stirrups, is preferred for procedures that last over 10 minutes or utilize anesthesia. It is important to keep in mind that in some states there are regulations for specific facility requirements when conscious sedation is utilized. Before developing an office surgical suite the physician should check with local regulatory committees so they will able to meet the local standards and needs assessments.

Preparing the Patient

For procedures that are performed in the office setting a clinician should prepare the patient the same way as they would for the similar in-hospital procedure. Important attention should be paid to the medical history and past medical history to make sure the patient is a good candidate for an in office procedure and is of low anesthetic risk. Patients with multiple medical problems, cardiovascular disease or neurological disease may be better served in the hospital setting. Consents similar to what one would obtain for a day surgery hospital procedure should be signed. It's important to remember that consent will be required not only for the surgical procedure but also for the anesthesia utilized. Basic preparatory instructions for the individual procedure should be given as well as post procedure instructions in case discharge planning is needed. Fasting is recommended when conscious sedation is required, which is abstinence from food for 8 hours and clear liquids for 2 hours.

Anesthesia

Although some office procedures can be performed without anesthesia some will require oral or intravenous sedation. The term conscious sedation implies a state in which patients can tolerate procedures with adequate cardiopulmonary function and respond to verbal commands. The American Society of Anesthesiologists has published guidelines for sedation and analgesia performed by medical staff that is not trained in the practice of anesthesia. In the office setting non-anesthesia residency trained physicians should limit patients to the American Society of Anesthesiologists classification I or II (Table I). The clinician should avoid procedures on patients with significant cardiac, respiratory or neurologic disease in the office setting (1, 2).

Per hospital policy, anesthesia records should be maintained on the patient's ventilatory and oxygenation status. Hemodynamic variables should be recorded frequently and at a minimum it should be recorded:

1. prior to the administration of anesthetic agents
2. following the administration of sedation
3. upon completion of the procedure
4. upon recovery
5. at the time of discharge

A designated medical professional (nurse, physician's assistant or physician) other than those performing the procedure should be present to monitor the patient's vital signs throughout the procedure. A staff member trained in Advanced Cardiac Life Support (ACLS) should be immediately available. The patient should have intravenous access. Naloxone and flumazenil should be available when opioids and benzodiazepines are used.

Anesthesia techniques will vary upon the physicians training and facility requirements. Most obstetrician gynecologists performing office surgical procedures should be versed in conscious sedation, administration of local analgesia, and paracervical blocks. Ideally patients undergoing diagnostic and therapeutic procedures receive moderate sedation. The definitions within the continuum of sedation are described in Table 2.

Local anesthesia
Local anesthesia can be a safe and effective means of providing analgesia for office procedures. Local anesthesia is defined as the elimination of sensations, especially pain in one part of the body using topical or regional injections of medications. Most Obstetricians Gynecologists will be educated in the use of local anesthetics during residency training. The secrets of success with local anesthetic use is injecting slowly, using a sufficient amount of medication and waiting for the medication to take effect. Several agents may be utilized and include Benzocaine, Mepivacaine, Bupivacaine, and Lidocaine. It is important to remember that local anesthetics have cardiac and central nervous system toxicity. Local anesthetics are frequently mixed with epinephrine. Symptoms of epinephrine overdose include tachycardia and hypertension, and one should watch for these signs when using local anesthetics containing epinephrine.

Paracervical block
Most gynecologists will be proficient in performing a paracervical block. Paracervical blocks are useful not only for cervical biopsies, cervical conization procedures but also for office D&C procedures and office hysteroscopy. In performing a paracervical block, in addition to the supplies needed for the local infiltration it is useful to have available a needle extender or long spinal needles. The application of 1% Hurricaine ^' spray or Lidocaine ointment prior to insertion of the needle may relieve some of the discomfort from inserting the needle. For the paracervical block injecting 10 mL of anesthetic (usually 1% Lidocaine) at the 4 and 8 o'clock positions and waiting 10 minutes gives excellent results. This is believed to limit sensation from the uterosacral nerve bundles from S2, S3 and S4. With this technique the only area of tenderness appears to be the fundus of the uterus and providing local anesthesia to this area is difficult as it is supplied by 10th thoracic nerve. (Figure 1)

Conscious sedation
Conscious sedation is defined as a minimally depressed level of consciousness where by a patient can maintain their own airway independently and respond to verbal commands. The medications used for conscious sedation procedures include local anesthetics, sedatives, anxiolytic and opioid analgesics. The ideal drugs to use in an office setting would have a quick onset and quick clearance rate. The medications utilized should have a predictable onset of action and minimal side effects. Anxiolytics and opioids are more commonly used by non-anesthesiologist practitioners for conscious sedation. The window of safety between effect and over sedation is narrow for sedatives and therefore limits their use in the outpatient setting for most physicians. It is important that the surgeon avoid turning their conscious sedation case into general anesthesia especially in the office setting. There is an approximately a 0.2% mortality rate with conscious sedation, mostly due to oversedation and inadequate monitoring (2).

Diazepam (Valium) is the most popular of the anxiolytics utilized however Midazolam (Versed) has also been used. Diazepam is popular because it can be given both intravenously and orally. The usual dose is 2.5 mg intravenously every 10 minutes to a maximum dose of 0.15 mg/kg or 10 mg. The draw back to diazepam is its long duration of action, and this is why some physicians prefer Midazolam. Midazolam can also be administered orally, intravenously or intramuscularly. It has a short half-life. The usual recommended dose is 1 mg intravenously every 5 minutes to a maximum dose of 0.07 mg/kg or 5 mg in the office setting (3).

The opioids are medications that will decrease the patient's awareness of painful stimuli. These drugs can produce respiratory suppression and should be used cautiously. The preferred drug in this class for conscious sedation is Fentanyl. Fentanyl has a quick onset of action and short half-life. In the office setting the standard dose utilized is 25-50 mg every 5 minutes, to a maximum of 3 mg/kg, or 250 mg intravenously (3). Morphine and Meperidine have also been used instead of Fentanyl however they have a longer duration of action. It is important to note that Morphine and Meperdine however appear to work better for patients' with visceral discomfort. Naloxone and flumazenil are two drugs that are essential to have available while providing conscious sedation using opioids and benzodiazepines. Naloxone (40 mg intravenously) is used to reverse the respiratory depression seen with opioids and flumazenil (0.2mg intravenously) is a benzodiazepine antagonist (Table 3).

Preventing complications

There are two basic groups of complications from surgical procedures. The 2 broad categories include

1. allergic reaction to the medications utilized
2. technical difficulty with the procedure

The key to managing procedure complications is being prepared. Careful history will help eliminate most allergic reactions, but a staff member trained in resuscitation and having agents like Benadryl (50 mg IV) and epinephrine may be life saving. Firstly, do not exceed the recommended limits for in office sedation for the medication you are utilizing. There is an approximately 0.2% mortality rate with conscious sedation. Those deaths are mostly due to the lack of adequate monitoring of cardiac and respiratory functions during the procedure (2). Good judgement is the key to avoiding complications. It is much better to discontinue the office procedure if it appears more complex than originally planned. To help improve outcome after any surgical complication it is important to have an emergency plan available for these unforeseen surgical complications (i.e. local ambulance number, local Emergency room number, crash cart and staff trained in ACLS techniques).

THE PROCEDURES

Office Hysteroscopy

Set up, Equipment and Preoperative Care
Office hysteroscopy is a useful tool for the evaluation of abnormal uterine bleeding, infertility and recurrent pregnancy loss. Typically an office hysteroscopy can be performed in a regular exam room without much modification. The most common media utilized for distention with office hysteroscopy procedures is CO2. CO2 is readily available and utilizes a low flow insufflator (100mL/ minute). It is very important to note that a CO2 insufflator for laparoscopy is a high flow insufflator and should NEVER be used for office hysteroscopy. An advantage of CO2 is its low cost, low "mess", and overall performance and safety. It is important to remember that CO2 however is not a good media for evaluation of patients with abnormal bleeding while they are bleeding. These patients may be better served with the use "liquid" distention media including high molecular weight dextran, sorbitol, normal saline or lactated ringer's solutions. Several hysteroscopy manufacturers have developed low cost complete fluid systems for office hysteroscopy procedures and aid in making the procedure safe and simple (4,5,6).

When starting to perform office hysteroscopy procedures it's important to make sure you have the correct equipment available. For office hysteroscopy there are two different kinds of hysteroscopes- rigid and flexible. Flexible hysteroscopes tend to be more expensive and have slightly poorer quality images when compared to rigid hysteroscopes. Most physicians prefer rigid hysteroscopes for office procedures. The standard office rigid hysteroscope is 4 mm in size however microhysteroscopes with 2.4 mm and 2.7 mm optics are available. The smaller size decreases the need for cervical dilation, which has the advantage of decreasing the pain, and bleeding associated with the procedure. In addition to the sheath size for the hysteroscope the physicians have a choice of telescope angle. Most physicians prefer to use a telescope at 0, 12, 15, or 30 degrees (4). There are lots of hysteroscopy systems available for the operating room use and office use. All systems have their particular advantages and disadvantages. Several systems should be tested in your office setting to determine which system is the best for you before purchasing a system. Look for a system which has the operating equipment you will need (graspers, forceps, scissors), chose a company with reliable service and a telescope that has the brightest clearest image that is within your budget.

Surgical Technique
After the patient has checked in and appropriate vital signs have been taken adequate analgesia should be given (Refer to anesthesia section of this chapter). An attempt to pass the hysteroscope without dilation should be made. However, the cervix may need to be dilated. Good techniques for cervical dilation include laminaria or Cytotec^' intravaginally. Since these techniques require preplanning it is best at the preoperative appointment to assess the cervix to determine if dilatation will be necessary. The problem with laminaria insertion is it requires a visit to the office the day prior to the procedure and many patients experience severe cervical/ uterine cramping. Another option is the use of Cyotec^' 400 mg orally 4 - 6 hours prior to the procedure.

The hysteroscope is usually inserted under direct visualization passing through the cervical canal into the endometrial cavity (4, 5,6). To add in visualization during the hysteroscopy, the cervix should be cleared of all blood using a sponge forceps prior to entering the cervical canal. Another trick to keeping the lens clean when using a liquid distention media is to start the distention media prior to entering the cervix. The running fluid at the tip of the hysteroscope upon entering the cervical canal aids in keeping the lens clean and aids in visualization at the start of the procedure. In addition if the media is cloudy upon entry, waiting 15-30 seconds allowing the continuous flow process to work, will provide a clearer field of vision. In contrast, if CO2 is used as the distention media, do not start the CO2 until after entrance into the cervical canal. This will avoid making blood tinged bubbles within the cavity which will obstruct the view.

Once the hysteroscope is passed through the cervical canal into the uterus a systematic overview of the cavity should be performed prior to performing any operative procedures. We generally inspect the fundus and locate both tubal ostia first then pull back to the level of the internal os and inspect the entire anterior then posterior wall of the uterus (Figure 2).

Postoperative Care
Most patients will have light spotting or light bleeding for up to 5 days after their hysteroscopy procedure and should be advised of such. Intercourse and douching should be restricted for 24 hours. Tampons may be utilized for the postoperative bleeding that occurs. Patients should be advised that they could have minimal cramping which is best resolved with a non-steroidal anti-inflammatory drug (NSAID) or other analgesic. Patients should be instructed to call if they have heavy bleeding, severe pain unresolved by the NSAID or fever >100.5 degrees.

Microlaparoscopy

Setup, Equipment and Preoperative Care
The technique of microlaparoscopy under local anesthesia has recently raised interest in the medical community due to its cost savings over in-hospital procedures. Several different microlaparoscopy procedures can be performed in the office setting however the difficulty in performing office microlaparoscopy for most physicians is not obtaining the training or equipment needed to do these procedures but with adequate office facilities to have a microlaparoscopy suite. In addition to adequate facility size, the following equipment should be available for the office procedure: a "micro" laparoscope and microlaparoscope lens, video camera, video monitor, trocar sheaths, laparoscopic scissors, graspers, and bipolar coagulation, a table capable of the Trendelenburg position, resuscitation equipment, intravenous line supplies, sterile surgical gowns and drapes. There are several "micro" laparoscopes available for use (7). Currently the refinements in fiber optic technology have lead to excellent quality 2-mm laparoscopes. Microlaparoscopes range from 25-27 mm in working length and have a 0-degree angle of view. There are 2-mm accessories available such as graspers, blunt probes and biopsy forceps. Faber and Coddington addressed concerns over optical clarity with these "micro" laparoscopes in a study published in 1997. This evaluation compared the accuracy of a 1.98 mm microlaparoscope with the standard 10-mm laparoscope. Findings did not differ (endometriosis scores and adhesions scores) between the two laparoscope sizes (8). To avoid major complications, office laparoscopy patients should have a minimal amount of prior abdominal surgery and no medical history which would suggest a large amount of abdominal adhesions.

Surgical Technique
It is important to realize that even experienced laparoscopic surgeons should perform office microlaparoscopy with an experienced microlaparoscopic surgeon prior to performing these procedures on their own. Even experienced laparoscopic surgeons will find the "micro" equipment more difficult to use at first until they get a feeling for the differences in depth perception and smaller field of view when compared to their full size counterparts. Procedures best suited for the microlaparoscopic technique include infertility evaluations with chromopertubation (7, 9), tubal ligation procedures (10), conscious pain mapping (11, 12) and second look procedures. The average length of an infertility evaluation procedure is 18 minutes (7). Some patients undergoing microlaparoscopy can have the procedure performed strictly under local anesthesia. However, this limits the length of the procedures and the amount of gas that can be used for insufflation. Most patients are better served with some conscious sedation this often allows the procedure to last 30 ' 45 minutes in contrast to only 15 minutes with local anesthetic alone.

For the microlaparoscopy procedure the patient is placed in dorsal lithotomy position on a table capable of performing Trendelenberg. A paracervical block should be give if a uterine manipulator is utilized. We generally use the Cohen cannula. The patient is sterilely prepped and draped. If conscious sedation is utilized this is given according to the guidelines described previously. Local anesthetic is than given in the area of the umbilicus. The use of a Verres needle/sheath combination system allows entry of the Verres needle without reintroduction of a trocar sheath for the procedure. The abdomen is insufflated and the pelvic organs visualized. Remember insufflation pressures will be higher in these patients because they do not have abdominal muscle relaxation. Pressures and gas flow should be titrated to patient comfort. Observation and chromopertubation is performed in a manner similar to that using the 10-mm laparoscope.

Postoperative Care
Routine postoperative care for laparoscopic procedures should be followed for the patients undergoing in office laparoscopic procedures. Patients should be stabilized prior to discharge and return for a postoperative incision check in one to two weeks. Patients should be advised to call if the experience heavy vaginal bleeding, pain not resolved by NSAID, or a fever >100.5 degrees.

Office Dilation and Curettage (D & C) and Endometrial Sampling

Preoperative Care, Equipment and Setup
The vast majority of office endometrial samplings and D&C procedures can be performed with minimal office modifications. Most of the equipment needed is readily available and disposable. In addition to the obvious cost savings for office D&C procedures, the office procedures are more time efficient for the physician.

Office D&C procedures may be performed for a variety of reasons but the most common indications include pregnancy termination and management of an incomplete abortion prior to 12 weeks of gestation. It is very important to confirm pregnancy status and location by ultrasound prior to performing the procedure. The most common reasons for in office endometrial sampling include evaluation for abnormal uterine bleeding, postmenopausal bleeding, and recurrent pregnancy loss evaluation and as part of an infertility work up (13,14,15,16).

Surgical Technique
The most popular technique for office curettage utilizes the Karman cannula. The Karman cannula is a soft catheter and is an efficient suction device as it has 2 suction ports. The larger the bore of the catheter the more effective the aspiration procedure. As the soft catheter works so well we find that there is a limited role for the sharp curettage technique. The soft catheter probably will reduce the risk of uterine perforation when compared to the traditional sharp curette. In choosing the size of the cannula the diameter of the canula should equal the size of the uterus using the standard sizing of the number of weeks of pregnancy. Therefore when performing a curettage for an incomplete abortion in a uterus measuring 8 weeks age of gestation, an 8mm cannula should be utilized. Office procedures should be utilized only on those patients with a uterine size less than 12 weeks of gestation. Prior to arrival at the office we usually pre-treat the patient with Valium 5 '10 mg orally. After check in and routine vital signs are obtained, a bimanual exam is performed to determine the uterine size. A speculum is inserted to perform a paracervical block. Please refer to the anesthesia section for this technique. After adequate anesthesia is induced the catheter should be passed through the cervical os. Sometimes cervical dilation is needed and this may be accomplished with dilators, laminaria (or its synthetic counterpart) or Cytotec.

Initially the chief purpose of uterine curettage was for endometrial sampling; however the classical curettage has been essentially replaced with the office endometrial sampling. Endometrial sampling is a diagnostic screening test and the use of an in office endometrial sampling procedure has essentially eliminated the need for many D&C's performed in the operating room. During the past 50 years many different instruments have been developed for office endometrial biopsies. Most of the sampling devices utilized for this purpose have a 5-mm or less outer dimension and are made of plastic. Some of these devices require a syringe or suction pump however the most popular endometrial sampling device is the disposable hollow plastic tube with an aspiration port that has a solid plastic obturator (Pipelle^').

Postoperative Care
Most patients do well after an in office endometrial curettage or sampling. The patients should be advised that they might have cramping and bleeding for 3-4 days after the procedure. Patients often respond well to NSAID for the uterine cramping. Patients should be advised to call if they develop a fever, have vaginal discharge, or have bleeding past 4 days.

Endometrial Ablation

New technology now allows the physician to perform office endometrial ablation. Several types of endometrial ablation devices are on the market, some utilizing water, balloons or impedance controlled bipolar radio frequency. In randomized studies 46% of patients were able to use the balloon technology in the office under local anesthesia (some with i.v. sedation) and 73% using the bipolar radio-frequency system were able to be performed in the office setting.

Novasure^® (bipolar radio-frequency) technology can be performed as an outpatient or office based procedure. The average treatment time is 90 seconds compared to 8-12 minutes for balloon technology. With the Novasure system the Novasure introducer sheath is introduced through the cervical os (Figure 3). The 3 dimensional bipolar electrode expands from the introducer sheath and with the aid of CO2 conforms and checks the integrity of the uterine cavity. The ablation is accomplished and the electrode is retracted into the sheath and removed. There is a 91% success rate (decrease in flow) and 41% amenorrhea rate (Table 4). The endometrial balloon (Thermachoice^®) is very easy to use (Figure 4). The catheter is primed and tested. The catheter is than introduced into the uterus much like a sound. The balloon is filled. The Thermachoice^® heats the fluid. After a heating period, 8-minute treatment period and cooling period the catheter is removed. Temperatures and uterine pressures are measured continuously. This helps confirm uterine integrity (17).

Surgical Technique
The surgical technique will depend upon the equipment utilized. Physicians who desire to use the ablation technology should be trained by those experienced in using the equipment. Contacting your local equipment sales representatives and surgeons to serve as experienced preceptors should be the easiest way to become proficient using ablation equipment. If these procedures are being performed in conjunction with hospital systems, there may be information on credentialed individuals in the medical staff office.

Postoperative Care
Most patients will do well after discharge. Generally a NSAID or similar medication is prescribed to control postoperative pain. Patients should be advised to contact the office with excessive postoperative pain that is not relieved by the NSAIDs or bleeding. In order to insure that the patient is happy with the ablation results it is important to educate your patients about the typical results seen with endometrial ablation. Most patients will not experience a decrease in the menstrual flow for approximately 3 menstrual cycles after the ablation. The percentage of decrease in flow and amenorrhea rates, which vary with the technology utilized, should be reviewed prior to the procedure. As many as 30-40% of women may need further intervention within 4 - 5 years; however, patient satisfaction remains high if the limitations are discussed preoperatively (18).

Saline Infusion Sonography (SIS)

Since the development of high-resolution ultrasound the SIS has been gaining in popularity. Numerous studies have looked at the benefit of ultrasound in establishing the diagnosis in women with abnormal uterine bleeding. However it sometimes is difficult to image the endometrial contents and rule out pathology on a reliable basis. The use of fluid instillation into the uterine cavity coupled with ultrasound has become a useful diagnostic tool. SIS is easily performed in the clinical setting and is remarkably well tolerated in most patients. The clinical utility of saline infusion sonography is not in its use to replace surgery but to identify those patients who need surgical intervention (19,20,21,22). There are multiple indications for SIS that are listed in Table 5.

Preoperative Care, Equipment and Set up
In order to perform SIS the minimum supplies include a SIS catheter, instillation media, a 20cc syringe, povidone-iodine solution, scopettes, a open sided speculum and an ultrasound that preferably has transvaginal capabilities. The most widely used media for instillation into the uterine cavity is saline; however other contrast media have been investigated, including Echovist^® and Albunex^® (23,24,25). These media do not appear to perform better than normal saline and are more costly. SIS can be performed during any time of the cycle; however performing SIS during the follicular phase will avoid the disruption of an early pregnancy. In addition during the follicular phase there is a thinner endometrium, which may aid in better evaluation of the uterine lining. Instilling saline during menses may lead to poor uterine distention so avoiding the menstrual cycle is preferred.

There are several SIS catheters on the market (diagram 7,8,9). Alternatively, pediatric foley catheters, insemination catheters, pediatric feeding tubes, can be used. The choice of the catheter will depend on the patient and therefore several catheter types should be available to the physician performing the SIS. In particular, one should have a thin stiff catheter available for those difficult nulliparous cervices and a balloon or cone type catheter for multiparous cervices. The balloon should be used in patients with multiparous cervices to occlude the os. This will limit the amount of media leaking out of the uterus and improve uterine distention (26, 27).

Technique
After performing a bimanual exam or baseline ultrasound to determine uterine position a speculum is inserted and the cervix is identified. The cervix may be cleansed with povidone-iodine or similar antiseptic solution. The catheter is primed with saline and then inserted through the cervical os. The exact placement will depend upon the catheter used. For a balloon type catheter the balloon should be positioned in the cervical canal or lower uterine segment and inflated. However the Goldstein^® SIS cone type catheter is inserted to 7cm or near the uterine fundus with the white acorn cone occluding the cervical os (Figure 5). A ring forceps may be needed to assist in placing the SIS catheter. Once the catheter is in place the speculum is removed with special care taken so the catheter is not dislodged. The vaginal ultrasound probe is inserted into the vagina and the uterus is imaged as the saline is infused slowly. Usually about 5-10 cc of saline is utilized in order to get good distention. It is important to remember the seal will not be watertight. Although a watertight seal may produce better images this will result in significantly more cramping with the procedure. When there is a large efflux of saline out the cervix, more saline may be needed to get good images. Visualization in both the longitudinal and transverse axis should be performed. The entire uterine cavity should be visualized from left to right broad ligaments longitudinally and from the cervix to the fundus in the coronal plane (Figure 8). It is important to realize that full distention of the uterus is not necessary to get a good quality evaluation. Indications for SIS are summarized in Table 5.

Postoperative Care
Most patients have minimal discomfort after an SIS procedure. Patients usually do well utilizing NSAID or similar analgesics for pain control. Patients should be advised to call with heavy bleeding that is not associated with menses that continues more than four days. Additionally patients should be evaluated if they have a fever greater than 100.5 degrees or vaginal discharge.

Contraceptive Procedures

As part of residency training most Obstetrician Gynecologists will obtain the clinical training needed to perform some of these procedures. More specifically training on the technique of insertion and removal of an Intrauterine device (IUD) and the Norplant^® system.

Currently 2 IUDs are available in the United States. Mirena^®, and Paragard T 380A Intrauterine Copper contraceptive^®. IUDs are generally recommended as a contraceptive method to women in a stable monogamous relationship who are not at risk for pelvic inflammatory disease, sexual transmitted diseases or ectopic pregnancies. IUDs are contraindicated in the following situations (28, 29):

1. suspicion of pregnancy
2. Congenital uterine anomaly
3. Fibroid uterus which severely distorts the uterine cavity
4. Pelvic infections
5. Unresolved abnormal Pap smear
6. Untreated cervicitis or vaginitis
7. Genital bleeding of unknown etiology
8. Women with multiple sexual partners
9. Leukemia and AIDS
10. Breast cancer
11. Ectopic pregnancy or history of ectopic pregnancy

The Mirena^® IUD consists of a T-shaped polyethylene frame with a steroid reservoir around the vertical stem (Figure 9). The reservoir consists of a cylinder made up of a mixture of levonorgestrel and silicone. There are 52 mg of levonorgestrel within the system which provides levonorgestrel at a rate of 20 mg/day initially this level declines to half that level at 5 years. Levonorgestrel is a progestogen, which is used in a variety of contraceptive products. There is a stable level of 150 - 200 pg/mL 3 weeks after insertion of the Mirena^® device. The T system is 32mm in length and width. The T-shaped body also has barium embedded which makes it radio-opaque. There is a monofilament string attached to the T-shaped body stem. Although the exact mechanism for contraception is not clearly identified it appears that the Mirena^® IUD has mostly local effects within the uterine cavity. Additionally Mirena^® may have an effect on ovulation. In a 1-year study of the system only 45% of cycles were ovulatory however in a 4 year study 75% of cycles were noted to be ovulatory. Contraceptive effectiveness is quoted to be 0.2 pregnancies per 100 women and the cumulative 5-year pregnancy rate of 0.7 per 100 women (28,29). Half of the pregnancies that occur while using the Mirena^® IUD are ectopic gestations, at a rate of 1 ectopic pregnancy in 1000 users per year (30). It is important to counsel your patients that Mirena^® can alter the menstrual bleeding pattern (28,29). During the first three to six months there may be an increase in vaginal spotting. Additionally it has been noted that approximately 20% of users will amenorrheic by one year (28).

The Paragard T 380A^® has a polyethylene body that is T-shaped. The vertical portion of the T is wound with 176 mg of copper wire along with a copper collar of 68.7 mg on each of the transverse arms. The exposed areas of copper are approximately 380 mm² hence the name. The Paragard has a monofilament thread attached the bulb end of the base of the T-shaped device. The available data indicates that the copper is continuously released into the uterine cavity. The additional copper load to the body from a copper IUD may precipitate symptoms in patients' with Wilson's disease (28). The exact mechanism in which the copper provides contraception is unclear however it is felt that there is interference with sperm transport, fertilization, and embryo implantation. The Paragard T 380A should be kept in place no longer than 10 years. (28,29,30,31,32) Women who use the copper IUD should be advised that blood loss at the time of menses might increase. There is an approximately 35% increase in menstrual blood loss in copper IUD users. (28)

If a woman conceives while an IUD is in place it is the manufacturers' recommendation to remove the IUD if the string is visible and the IUD is easily removed. It is important to confirm the location and viability of the pregnancy prior to removal of the IUD. Patients in whom the IUD can't be removed or chose not to have the IUD removed should be counseled that there is increased risk of septic abortion and preterm labor/ delivery.

IUD Insertion Technique
The IUD should only be inserted, managed and removed by clinicians trained in IUD use. Both the Mirena^® and Paragard^® have different techniques for getting the IUD ready for insertion please refer to the package inserts for guidance on these techniques. IUDs can be inserted at any time during the menstrual cycle. Traditionally physicians have preferred to insert an IUD at the time of menses to insure that the patient is not pregnant. However insertion at the time of menses increases the risk of expulsion of the IUD during the first two months of use. (31) It is best to give patients a non-steroidal anti-inflammatory drug one-hour prior to IUD insertion. After loading the IUD into its insertion device the uterus should be examined by bimanual examine and a speculum inserted into the vagina and the uterus sounded. On both IUDs there is an adjustable flange that should be set to the length to which the IUD should be inserted. A single tooth tenaculum is applied to the anterior lip of the cervix to aid in cervical and uterine straightening. Hurricane spray or local infiltration of Lidocaine may be utilized prior to tenaculum placement. The IUD must be inserted within 5 minutes of loading so that the arms will spring back open after inserting. The IUD is then passed through the cervical canal to the fundus. The plastic flange should be at the level of the internal os if the IUD is inserted correctly. Once correct placement is confirmed the insertion device is used to release the arms of the IUD. The insertion device is then removed gently so as not to disturb the placement of the IUD. The monofilament thread should be cut approximately 2 cm from the external os. The risk of uterine perforation is 1 in 1360 insertions (31). Insertion immediately in the postpartum period, particularly during lactation has been associated with an increased risk of uterine perforation. However there is no increased risk of perforation if the IUD is inserted immediately after expulsion of the placenta. But it is preferred by these authors to delay insertion of an IUD until the second postpartum month (31).

Postoperative Care
After insertion of an IUD the patient should be taught how to palpate the strings monthly. Patients should be seen in 3 months to review bleeding pattern and concerns with the IUD. At that time a speculum examine should be performed to rule out partial expulsion of the IUD.

Removal of an IUD is generally easy. It is important to note the type of IUD prior to removal. The strings are grasped with a ring forceps and pulled outward through the vagina until the IUD is expelled. If the strings break off during removal or the strings are not visible, removal under ultrasound guidance is advisable. Under ultrasound guidance while using packing forceps the lower stem is located and using gentle traction is removed through the internal then external os. If gentle force does not produce the IUD then the IUD may be embedded and in such cases hysteroscopic removal in the Operating Room may be needed. It is important to note that some IUDs that are used abroad do not have strings and are designed for permanent placement and should not be removed in the office setting (33,34,35).

Norplant
The Norplant Contraceptive system consists of 6 silastic capsules each filled with 36 mg of levonorgestrel powder. The capsules should be placed in the subcutaneous layer of the inner aspect of a woman's non-dominant arm. Norplant capsules are designed for 5 years of use with a typical first year failure rate of 0.09% and a cumulative failure rate of 1.1% over 5 years. Discontinuation of use prior to 5 years appears to be the major problem with the Norplant system. The major reasons for discontinuation of use include bleeding abnormalities, weight change, headaches, and change in libido. Women with active venous thrombosis, unexplained vaginal bleeding, and history of stroke or breast cancer are not candidates for Norplant. Women utilizing the drugs listed in Table 6 should not use Norplant as these drugs increase the metabolic clearance of levonorgestrel, which can decrease its efficacy. The most common side effects of the Norplant system include changes in the menstrual pattern, weight changes and headaches (36).

Norplant Insertion technique
Both insertion and removal of the Norplant system require formal training to avoid complications. Insertion of the Norplant should be scheduled during the first week after menses. Patients should be told to avoid intercourse during this time to avoid inadvertently becoming pregnant. Location for placement of the Norplant capsules is the first decision that should be made. Ideally the capsules should not be noticeable. It is important to remember good placement of the capsules translates into easy removal. The location of the Norplant capsules to avoid detection should be on the inner forearm. Ideally the location should be above the level of the nipple and medial enough that it lies on the medial aspect of the arm. The capsules are traditionally fanned with the capsules being approximately 15 degrees apart from each other (Figure 10). Once a location is chosen one should use the Norplant template included in the kit and mark a dot for the incision site and a dot for the position of each of the distal tips. The Norplant kit contains all the necessary equipment needed for a standard simple insertion.

Patients should be in the supine position when the capsules are inserted. The arm should be placed flat on the bed with the palm upwards and the elbow bent to 90 degrees (like signaling for a right turn). Local anesthesia is given at the incision site taking care not to use too much anesthesia which may distort the tissue planes. The needle should be advanced its full length just under the skin along the planned tract of each capsule. After adequate anesthesia is obtained a 3-mm horizontal incision should be made at the incision site that has been chosen. The obturator should be loaded into the trocar provided in the kit. The trocar with obturator in place is introduced directly through the incision with the open end of the bevel facing the ceiling. The skin below the incision site should be held in place for traction. The trocar is then advanced until the level of the second line on the trocar is at the incision site. The obturator is removed and the silastic capsule is introduced. The obturator in then replaced. The obturator is used to push the implant down the shaft of the trocar and into place. Once in place the obturator and trocar are removed gently and slowly. This procedure is performed a total of 6 times at 15-degree angles until all capsules are placed. After all 6 capsules are placed the edges of the incision should be reapproximated with steri-strips.

Postoperative care of Norplant
Patients who have the Norplant inserted close to the time of ovulation should use barrier contraception for one week. Patients should be advised to check for signs of infection at the incision/insertion site, which occurs in less than 1% of Norplant insertions.

Norplant Removal
The most important thing to remember is that good placement of the Norplant capsules lead to easy removal. Described below is one method of removal of the Norplant system. As with other procedures many techniques have been developed to aid with the removal of the capsules. No particular procedure appears to have an advantage over another. It is recommended that removals be scheduled for a 20-minute appointment. Most Norplant removals take 15 minutes however on a rare occasion we have known them to take up to 45 minutes. Patients should be advised that removal is more painful than insertion. The incidence of difficult removal is quoted by Wyeth-Ayerst to be about 13%. The area should be palpated and the location of the Norplant capsules identified. The following equipment is needed for removal. An examining table, sterile gloves, sterile drapes, antiseptic solution, Lidocaine or similar anesthetic, needles syringes, an 11 blade scalpel, marker, straight and curved mosquito's or a similar clamp, Steri-strips, sterile gauze and tape.

First mark the location of each capsule. If all capsules can not be identified, localization by ultrasound or X-ray may be necessary (36,37,38,39). The area is then cleansed with betadine and an incision site is made where all the capsules converge after giving local anesthesia. Additional anesthesia should then be given under the base of each capsule and behind each capsule for about a 1 cm of its length. In addition to providing anesthesia this will serve to raise the capsules. Injection of the anesthetic above the capsules may obscure their location and this should be avoided. Pressure is then applied to the distal end of the implant toward the incision to see if the tip can be milked into view. Most of the time a fibrous sheath will be noted around the implant. This sheath should be nicked, and then the implant milked out through this nick then through the incision on the arm. Unfortunately not all implants can be removed this easily; occasionally the incision will need to be probed and the capsule grabbed. Using a forceps to grab the fibrous tissue over the implant nicking this tissue then removing the implant may be needed. Occasionally it is hard to grab the implant with the forceps and manipulating the skin and implant to an area over the forceps may be easier then a fishing expedition for the capsule. Other techniques have been described for Norplant removal and are summarized in Table 7. After all the capsules are removed a steri-strip should be applied and the incision dressed with sterile gauze (36-45).

Conclusions

Although many procedures described above are easy to perform in an office setting it is important to take into consideration the practitioner's training, experience, facility size and staffing issues before performing these procedures in an office setting.

Table 1: American Society of Anesthesiologists (ASA) Patient Classification ⁽¹⁾

Table 2: Explanations of various levels of anesthetic sedation ⁽³⁾

Minimal sedation- may be achieved with oral or intravenous medication. Cognitive function may be impaired but the patient responds normally to verbal commands. Ventilatory and cardiovascular functions are unimpaired

Moderate sedation and analgesia- ordinarily referred to as conscious sedation. Medications are usually administered intravenously. Consciousness is depressed but the patient can respond to verbal commands. The patient is capable of maintaining a patent airway and spontaneous ventilation; cardiovascular function is well maintained.

Deep sedation- results in substantial depression in consciousness, the patient is not arousable, except by repeated painful stimuli

General anesthesia- is drug-induced loss of consciousness

Table 3: Agents approved for conscious sedation and dosing regimens for adults ⁽³⁾

Table 4: Endometrial Ablation Procedures

Table 5: Indications for Saline Infusion Sonography

Abnormal uterine bleeding
Postmenopausal bleeding
Perimenopausal bleeding
Mullerian anomalies
Recurrent pregnancy loss
Infertility

Table 6: Drugs which decrease the effectiveness of the Norplant system (35)

Phenobarbital
Phenytoin
Carbamazepine
Rifampin

Table 7: Norplant Removal Techniques ^(36-45)

Diagrams/Pictures

1. Drawing of paracervical block
2. Hysteroscopy picture of uterine cavity with posterior intrauterine mass
3. Novasure^®
4. Thermachoice^® Balloon System
5. Goldstein catheter
6. SIS catheters Balloon type
7. SIS catheter insemination type
8. SIS evaluation
   1. normal intrauterine cavity
   2. intrauterine mass
   3. localized posterior wall thickening
   4. Bicornuate or septate uterus visualized prior to instillation of saline
9. Mirena
10. Pictures of Norplant insertion

FOOTNOTES

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3. Duke JC: Education Module for nonanesthesiologists providing sedation and analgesia for diagnostic and therapeutic procedures. Denver Health Department of Anesthesiology, Denver Colorado

4. Bieber EJ: Distention Media In:Gynecologic Resectoscopy. Bieber EJ, Loffer FD editors, Blackwell Science, Cambridge Massachusetts,1995 p 62.

5. Cohen MR, Dmowski WP: Modern hysteroscopy: Diagnostic and therapeutic potential. Fertil Steril 24:905, 1973.

6. Salat-Baroux J, Hamou JE, Maillard G: Complications from microhysteroscopy. In Siegler A, Lindemann HJ (eds): Hysteroscopy: Principles and Practices. Philadelphia, Lippincott, 1984, p 112.

7. Palter, Steven: Office microlaparoscopy under local anesthesia. In: Obstetrics and Gynecology Clinics of North America-Gynecologic Operative Endoscopy March 1999, page 111

8. Faber BM, Coddington CC III, Microlaparoscopy: a comparative study of diagnostic accuracy. Fertil Steril 67:952-954, 1997.

9. Milki AA, Tazuke SI: Office laparoscopy under local anesthesia for gamete intrafallopian transfer: Technique and tolerance. Fertil Steril 68:128-132, 1997.Ory, HW Women's Health Study: Ectopic pregnancy and intrauterine contraceptive devices: New perspectives. Obstet Gynecol 1981; 57:137-144.

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28. Ory, HW. Women's Health Study: Ectopic Pregnancy and intrauterine devices: New Perspectives. Obstet Gynecol 1981;57:137-144.

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