FERTILITY AND STERILITY Copyright 0 1980 The American Fertility Society
Vol. 33, No.2, February 1980 Printed in U.s A.
MINILAPAROTOMY UNDER LOCAL ANESTHESIA FOR OUTPATIENT STERILIZATION: A PRELIMINARY REPORT*t
ROGER B. LEE, M.D., F.A.C.O.G., F.A.C.S.* JOHN A. K. BOYD, M.D.
Department of Obstetrics and Gynecology, Walter Reed Army Medical Center, Washington, D. C. 20012
An outpatient sterilization program was started at Silas B. Hays Hospital, Fort Ord, California, and later extended to Malcolm Grow USAF Medical (;t>ter and the Walter Reed Army Medical Center. From January 1976 to June 1978, two hundred and eight outpatient minilaparotomy Pomeroy tubal ligations were performed under local anesthesia. The minilaparotomy technique, using standard operating room equipment, is described. The average operating time was 31.8 minutes and the complication rate was 2.5%. Fertil Steril 33:129, 1980
In recent years, female sterilizations have become increasingly popular for a variety of personaI, social, and economic reasons. Despite the relative technical simplicity and safety of vasectomy, sterilization of the female is still preferred by a significant segment of the population. At the present time, postpartum tubal ligation is a popular procedure performed because of its convenience, but there is still a large demand for nonpuerperal female sterilizations which are now done primarily by the laparoscopic or vaginal approach. Unfortunately, unlike male sterilization, nearly all common methods of female tubal ligation require either general anesthesia or expensive specialized equipment, or both. Because of the above disadavantages, there have been a number of recent attempts to simplify nonpuerperal female sterilization by making use Received May 21,1979; revised September 11, 1979; accepted September 17. 1979. *Presented at the Twenty-Sixth Annual Meeting of the Armed Forces District Meeting of the American C()llege of Obstetricians and Gynecologists, October 9 to 13, 1977, New Orleans, La. tThe opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense. *To whom reprint requests should be addressed.
of a "minilaparotomy" incision, 1 which is a 3- to 4-cm transverse incision usually placed about two fingerbreadths above the pubic symphysis. The chief advantage of this approach is that it can be done easily and safely under simple narcotic analgesia and local infiltration anesthesia by persons with minimal surgical training. This was demonstrated by two large series, in Bangladesh2 and India,3 which consisted of 600 and 12,536 patients, respectively. In the Bangladesh series, the operations were performed largely by paramedics, whereas in the Indian study, most of the procedures were carried out by general practitioners with a very low complication rate. The major technical difficulty with the minilaparotomy has been that of visualizing and manipulating the tubes through a small incision while the uterus, in its nonpuerperal state, is well down within the pelvis. A number of different instruments, including a protoscope,4 a Cusco speculum,5 and even a modified laryngoscope,6 have been used from above to simplify visualization. From the vaginal end, a Semm's cannula7 and other instruments (Harris uterine manipulator, and Rubin's cannula) attached to the cervix have been used as lever arms to elevate the uterus into the operating field. This paper describes a minilaparotomy technique especially developed to obviate the use of 129
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special instruments. The only instruments used were standard ones which can be found in virtually any operating suite. We have attempted to devise a procedure that can be performed with minimal cost, risk, and discomfort in almost any hospital's operating room or outpatient surgical clinic. METHODS
All of the minilaparotomy procedures were performed at Silas B. Hays Army Hospital, Malcolm Grow USAF Medical Center, and the Walter Reed Army Medical Center by the senior author and by residents of the department of family practice and the department of obstetrics and gynecology. The patient was provided information about the different methods of sterilization available; namely, laparoscopic, vaginal, or minilaparotomy, as well about type of anesthesia (general or local). She was examined and a Papanicolaou smear was obtained. Patients taking contraceptive pills were advised to continue taking them until the day before surgery, and those wearing intrauterine devices (IUDs) had the devices removed at the time of surgery. The patient was admitted to the hospital on the day of surgery. She was instructed to shave her lower abdomen and suprapubic area on the day prior to surgery and was told not to eat or drink anything after midnight. After the patient had been admitted to the hospital, she was premedicated with 50 to 75 mg of meperidine intramuscularly 0.5 to 1 hour prior to surgery. In the operating room, the well-sedated but cooperative patient was placed in the semidorsallithotomy position. An intravenous solution of 5%
FIG. 1. A tenaculum on the anterior lip of the cervix, taped to a Hanks' dilator, is shown within the cervical canal.
February 1980
dextrose in lactated Ringer's solution was started, and 5 mg of diazepam were injected slowly through the intravenous line. The abdomen and vagina were scrubbed gently with povidone-iodine. Using a Grave's speculum in the vagina for visualization, the anterior lip of the cervix and the uterosacral ligaments were anesthesized with 1% mepivacaine hydrochloride. Two to three milliliters of the local anesthetic were injected into the anterior lip of the cervix and approximately 5 ml were injected into each uterosacral ligament. Anesthetization of the uterosacral ligaments is very important, since it almost entirely eliminates the usual discomfort resulting from traction on the ligaments when the uterus is manipulated. A single-toothed tenaculum was then placed on the anterior lip of the cervix. If an IUD was present, it was removed. An appropriate-size cervical dilator was introduced into the uterine cavity and taped to the tenaculum, forming a lever arm which could be used to elevate the fundus into the operating field (Fig. 1). The bladder was emptied with a small, straight catheter in order to prevent an inadvertent cystotomy. Another 5 mg of diazepam were given intravenously as needed. The patient was then draped with sterile sheets and the site of the incision, located two fingerbreadths above the suprapubic symphysis, was locally anesthesized with 1% mepivacaine. A 3- to 4-cm transverse skin incision was made. As the incision was carried deeper, the fascia and the peritoneum were injected with the same local anesthesia. The fascia was opened in a transverse manner. Kelly clamps placed on the upper fascial edge were elevated, and the anterior rectus sheath was freed from the underlying muscles by sharp dissection. While Kelly clamps were used to separate the rectus muscles, the peritoneum was grasped at the most superior border and opened with scissors. Once the peritoneal cavity was entered, the patient was placed in the Trendelenburg position. A finger was then inserted into the incision to sweep the intestines from the uterus and the tubes as the instruments attached to the cervix were used to elevate the uterus into the field. Two Army-Navy retractors were used to facilitate exposure. If the fallopian tubes could not be seen easily by direct visualization, a vein retractor was introduced beside the palpating finger, passed behind the broad ligament, and used to hook the fallopian tube gently, bringing it into the field (Fig. 2). The midportion of the tube was then grasped with a Babcock clamp (Fig. 3). The round ligament was not
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cutaneous tissue was closed with 000 Vicryl, and the skin was closed by a subcuticular stitch using 000 plain catgut. Aeroplast spray was used to seal the incision. The patient was observed for 2 to 4 hours and was discharged on the same day, provided that she did not have any postoperative complications. She was given a prescription for a mild analgesic. Prophylactic antibiotics were not used. The patient was allowed to resume normal activities, e.g., work, sexual intercourse, and bathing, as soon as she was comfortable. Strenuous exercise was discouraged for 2 weeks, and her postoperative checkup was 4 to 6 weeks after the surgery. RESULTS
Profile. The average age of the patients was 32.2 years (range 20 to 45) (Table 1). Of the patients, 6.2% were 40 years old or older, and 89% were taking oral contraceptives. The average gravidity was 2.4 (range 0 to 6), and the average parity was 2.3 (range 0 to 6) (Table 2). The average age of the youngest child was 6.7 years (range 2 months to 19 years). Contraception. Prior to surgery, most of the pa-
2
3 FIGS. 2 AND 3. A 4-cm transverse abdominal incision is made approximately 4 cm above the pubic symphysis; a vein retractor lifts the fallopian tube into view of the surgeon. Army-Navy retractors are used to separate the abdominal incision.
grasped, since this is usually very painful. On occasion, when the tube was sensitive, the peritoneum was easily desensitized with a spray of mepivacaine. The knuckled portion of the fallopian tube, away from the underlying blood vessels, was ligated with plain 00 catgut and was then excised (Figs. 3 and 4). The same procedure was repeated with the other fallopian tube. In closing the abdomen, the peritoneum was left opened. The fascia was closed by a running 0 Vicryl suture, the sub-
FIG. 4. Plain 2-0 catgut is used to ligate a portion of the fallopian tube that is clear of any blood vessels.
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TABLE 1. Patients' Ages at Time of Surgery No.
Age
20-24 25-30 31-34 35-40 41-44 45-50 Total
%
34 53 47 61 11 2
16.4 25.5 22.6 29.3 5.3 0.9
208
100
tients (65.9%) were taking contraceptive pills or were using an IUD (Table 3). Of the 10.6% who were not using any contraception, most had given birth or had had an abortion within 3 months. None of the patients with IUDs showed any evidence of actinomycosis on pathologic examination of the tubal specimens. Surgery. The average time for surgery, including the time from the injection oflocal anesthesia to the abdominal area to the last skin suture, was 31.8 minutes (range 14 to 60 minutes). The average amount ofl % mepivacaine was 34.5 ml (range 21 to 67 ml): Estimated blood loss was 20 to 30 ml, and there were no blood transfusions. In every case, a segment of each fallopian tube was obtained and pathologically examined and verified. Complications. There was a 2.5% minor complication rate (Table 4). Two patients had developed sterile seromas in the abdominal incision and two had wound infections treated by drainage. There were no major complications such as bowel or bladder injuries, pelvic infections, or severe bleeding. There were no deaths. Some minor problems were encountered. All but nine patients (4.3%) left the recovery room within 2 to 4 hours after surgery. Three patients had severe nausea and vomiting requiring an overnight hospital stay and parenteral antiemetic medication. Five patients required an overnight stay because of their inability to awaken completely from the meperidine and diazepam. One patient stayed overnight for her convenience. In eight patients (3.8%), the tubal ligation could not be performed (Table 5). One of six nulliTABLE 2. Parity of the Patients Parity
0 1 2 3 ;;.4 Total
TABLE 3. Types of Contraception Used
Birth control pills IUD Condom Foam Diaphragm Rhythm Coitus interruptus None
105 32 21 12 8 6 2 22
Total
208
208
%
50.5 15.4 10.1 5.8 3.8 2.9 0.9 10.6 100
gravidas had extremely tight uterosacral ligaments, making it impossible to elevate the uterus into the operating field. The tubal ligation was finally accomplished with the help of general anesthesia. Four patients, none of whom had a history of pelvic infections, had pelvic adhesions. In one case, the adhesions were due to endometriosis and in another case attributed to a previous cesarean section. Two patients had a retroverted uterus associated with obesity and a protuberant abdomen. One patient was 5 feet 3 inches and weighed 140 pounds; the other was 5 feet 7 inches and weighed 180 pounds. Another patient had a retroverted uterus which was enlarged to 6 to 8 weeks, due to the presence of fibroids. Abnormal Menstruation. Of 142 women who responded to the 6-month questionnaire (see Appendix 1),17 (11.9%) complained of menstrual periods that they considered abnormal. Two patients who complained of amenorrhea were treated successfully with Provera; one of these patients had been taking oral contraceptives prior to the surgery. Ten of the seventeen patients complained of irregular menstrual periods. Seven of these patients had been taking oral contraceptives prior to the surgery and five ofthe seven had had a history of irregular menstrual periods before taking birth control pills. Two of the seven patients had neither a history of irregular menstrual periods nor a history of having taken birth control pills to explain their abnormal vaginal bleedings. Pelvic Pain. One patient (0.7%) had been having right lower-quadrant pain lasting for 1 day exactly 14 days before each menstrual period, consistent with ovulation. She had been taking birth control pills for 10 years.
No. of women
6 46 81 60 15
No.
Contraceptive
TABLE 4. Complications of Minilaparotomy Pomeroy Sterilization Wound Complication
No.
%
Seroma, hematoma Infection
3 2
1.5 1.0
Total
5
2.5
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MINILAPAROTOMY UNDER LOCAL ANESTHESIA FOR STERILIZATION
TABLE 5. Failed Procedures No.
Tight uterosacral ligaments Endometriosis Pelvic adhesions Fibroids Obesity with retroverted uterus
3
Total
8 (3.8%)
1 1 1
2
Subsequent Pregnancy. At 6 months, there were no pregnancies in the 142 patients who responded. Request for Reversal. One of the one hundred and forty-two responders has sought information about a reversal. She obtained a divorce 3 months after the sterilization and remarried 6 months later. DISCUSSION
We are encouraged by the favorably low risks and convenience to the patients. By avoiding ligation of the blood vessels, we hope to lessen the chances of abnormal menstrual periods and postoperative pain. As mentioned, the procedure is being done by family practice residents and by the obstetric and gynecology residents. The technique is easily learned. Furthermore, the use of standard operating room equipment and instruments should make the minilaparotomy operation the surgery of choice for hospitals that cannot obtain a laparoscope or for hospitals that are short of anesthesiologists. The procedure provides for minimal patient hospitalization and expense. Even though our present series of patients is small, it appears that minilaparotomy under local
anesthesia may prove to be the method of choice for nonpuerperal tubal ligation in selected patients. Although it had already been found successful in two large studies, in Bangladesh2 and India,3 one naturally wonders whether or not women in more comfort-oriented societies like ours will find it acceptable. Having one's abdomen opened while one is "awake" is bound to produce certain misgivings. Most of our patients, however, tolerated the procedure remarkably well. Our recommendations to physicians who will be performing the minilaparotomy under local anesthesia are as follows: (1) Obesity is a relative contraindication, especially with a protuberant abdomen. Until more statistics are available, it is recommended that the patients selected for minilaparotomy under local anesthesia be within 20% of their ideal weight. (2) Minilaparotomy is contraindicated for patients with a fixed retroverted uterus. Look for a history of pelvic inflammatory disease or endometriosis. (3) Until larger series are available, the procedure should not be performed in the physician's office. An ambulatory surgical center is recommended. (4) Removing the IUD at the time of surgery is convenient to the patient and does not produce any postoperative pelvic infection. Likewise, we did not encounter any postoperative complications by having patients continue taking birth control pills until the day of the surgery. At a time when there is major concern about rising medical costs both in civilian hospitals and in military hospitals due to expensive and elaborate surgical equipment and expensive inpatient nursing, we have been encouraged that mini-
APPENDIX
1
The Six-Month Questionnaire 1. Your new address if applicable: 2. Are you having any of these problems after your surgery? a. Pregnancy? Yes or No b.
Abnormal periods? Yes or No If you answered yes, did you ever have this problem before the tubal ligation? Please describe.
c.
Pelvic pain? Yes or No If yes, did you ever have pains in the pelvis before the tubal ligation? Please describe.
d.
Have you had any GYN surgery since the tubal ligation? Yes or No. If yes, what was done and for what reason?
3. Would you like to have your tubes put back together?
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laparotomy performed with routine operating room equipment under local anesthesia for outpatient sterilization will fill a vital need in medical care by decreasing the cost to the hospital and to the patient. Addendum. Dr. A. Jefferson Penfield has published similar results with the use oflocal anesthesia in Minilap sterilization. 13 Acknowledgment. The illustrations were drawn by Steven B.
Lee.
REFERENCES 1. Shepherd MK: Female contraceptive sterilization. Obstet
Gynecol Survey 29:750,1974 2. Chowdhury S, Chowdhury A: Tubectomy by paraprofessional surgeons in rural Bangladesh. Lancet 2:567,1975
February 1980 3. Dawn CS, Banergee MM: Minilaparotomy as a revolutionary approach for tubectomy in rural India. J Indian Med Assoc 66:275, 1976 4. Stevenson TC: Abdominal sterilization using the proctoscope. J Obstet Gynaecol Br Commonw 78:273, 1971 5. Greenholf MC, Roberts HR: Laparoscopic sterilization through Cusco's speculum. Br Med J 3:304,1971 6. Lind T, Taylor OJ: A modified laryngoscope for female sterilization. Lancet 2:347,1976 . 7. Saunders WG, Munsick RA: Nonpuerperal female sterilization. Obstet Gynecol 40:448, 1972 8. Gomel V: Tubal reanastomosis by microsurgery. Fertil Steril 28:59, 1977 9. Garb A: A review of tubal sterilization failures. Fertil Steril 00:291, 1900 10. Boysen H, McRae LA: Tubal sterilization through the vagina. Am J Obstet Gynecol 58:488, 1949 11. Lull CB, Mitchell RM: The Pomeroy method of sterilization. Am J Obstet Gynecol 59:1118,1950 12. Prystowsky H, Eastman NJ: Puerperal tubal sterilization. JAMA 158:463, 1955 13. Penfield AJ: Obstet Gynecol 54:184,1979