Comparison of Microlaparoscopy and Conventional Laparoscopy for Tubal Sterilization Under Local Anesthesia with Mild Sedation

Comparison of Microlaparoscopy and Conventional Laparoscopy for Tubal Sterilization Under Local Anesthesia with Mild Sedation

August 2001, Vol. 8, No. 3 The Journal of the American Association of Gynecologic Laparoscopists Comparison of Microlaparoscopy and Conventional Lap...

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August 2001, Vol. 8, No. 3

The Journal of the American Association of Gynecologic Laparoscopists

Comparison of Microlaparoscopy and Conventional Laparoscopy for Tubal Sterilization Under Local Anesthesia with Mild Sedation M. Bulent Tiras, M.D., Oznur Gokce, M.D., Volkan Noyan, M.D., Hulusi Bulent Zeyneloglu, M.D., Haldun Guner, M.D., Mulazim Yildirim, M.D., and Francisco Risquez, M.D. Abstract Study Objective. To compare tubal sterilization performed by microlaparoscopy and conventional laparoscopy. Design. Prospective, randomized trial (Canadian Task Force classification I). Setting. Gazi University School of Medicine. Patients. Twenty women undergoing surgical sterilization. Intervention. Ten sterilizations by conventional laparoscopy and 10 by microlaparoscopy. Measurements and Main Results. The techniques were comparable in quality of visualization, operating time, amount of drugs used for sedation and local anesthesia, and intraoperative pain scores. However, the postoperative analgesic requirement was significantly less in women treated by by microlaparoscopy. Conclusion. Tubal sterilization by microlaparoscopy does not differ greatly from conventional laparoscopic sterilization. (J Am Assoc Gynecol Laparosc 8(3):385–388, 2001)

Of 650,000 to 700,000 surgical sterilizations performed annually in the United States, more than 50% are done laparoscopically.1 Laparoscopic tubal sterilization is traditionally performed by laparoscopy under general anesthesia; however, thanks to improved technology, microlaparoscopic procedures under local anesthesia have been performed for the last 2 decades.2 A preliminary report stated that nine such procedures were performed under local anesthesia and sedation, and visualization of pelvic organs was confirmed.3 Today, such surgery is performed with sedation as necessary, in a short time, with more advanced instrumentation.4 Early studies mostly described diagnostic procedures, and no large trials evaluated microlaparoscopic

surgery. Microlaparoscopy seems to be as effective as conventional laparoscopy, is safer and less traumatic, and may be done as an office procedure under local anesthesia.5,6 We compared tubal sterilization performed by microlaparoscopy or conventional laparoscopy, both under local anesthesia with mild intravenous sedation. Materials and Methods Twenty women requesting surgical sterilization and with no contraindications for laparoscopy participated after providing written informed consent. Exclusion criteria were body mass index (BMI) above 28, no major systemic disease that altered general

From the Departments of Obstetrics and Gynecology, Gazi University School of Medicine, Besevler (Drs. Tiras, Gokce, Guner, and Yildirim) and Baskent University (Dr. Zeyneloglu), Ankara, Turkey; Department of Obstetrics and Gynecology, Kirikkale University School of Medicine, Kirikkale, Turkey (Dr. Noyan); and Centro Medico Docente La Trinidad, Caracas, Venezuela (Dr. Risquez). Address reprint requests to M. Bülent Tıras, M.D., Cicekdagi Sok. No. 12/2 GOP, 06 700 Ankara, Turkey; fax 90 312 466 06 18. Accepted for publication February 21, 2001. Reprinted from the JOURNAL OF THE AMERICAN ASSOCIATION OF GYNECOLOGIC LAPAROSCOPISTS, August 2001, Vol. 8 No. 3 © 2001 The American Association of Gynecologic Laparoscopists. All rights reserved. This work may not be reproduced in any form or by any means without written permission from the AAGL. This includes but is not limited to, the posting of electronic files on the Internet, transferring electronic files to other persons, distributing printed output, and photocopying. To order multiple reprints of an individual article or request authorization to make photocopies, please contact the AAGL.

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Results

health, and no previous abdominopelvic surgery that could affect mean operating time, lead to technical difficulties, and cause problems of visualization. Women were assigned in pairs to one of the two techniques by blocked randomization, using a blocking factor of 2.

The groups did not differ in baseline clinical features except for parity (Table 1). Mean body weight and BMI were not different, which was important because sedative dosages were adjusted according to body weight. The groups did not differ in mean operating time, postoperative observation, amounts of local anesthetics, midazolam, and fentanyl administered, and intraoperative pain scores (p >0.05; Table 2). Postoperative analgesic requirements were significantly higher in patients undergoing conventional laparoscopy (p <0.05; Table 3). Quality of visualization did not differ between groups (p >0.05; Table 4).

Operative Technique All procedures were performed by one surgeon (MBT) and one resident. With patients in dorsolithotomy position, intravenous midazolam 0.1 mg/kg and fentanyl citrate 1 µg/kg were administered for sedation, and dosages were adjusted according to sedation and pain status. For local anesthetic, 5 ml of bupivacaine 0.5% was applied to the periumbilical and right and left suprapubic regions. Patients were monitored continuously during the operation. For conventional laparoscopy, pneumoperitoneum was achieved with 1.5 to 2 L CO2. A 10-mm cannula was inserted through the periumbilical region and two 5-mm ones through the right and left suprapubic regions. Both fallopian tubes were coagulated and cut 2 to 3 cm distal to the cornual region with bipolar cutting forceps. For microlaparoscopy, a 2-mm special Veress needle (Origin Medsystems, Menlo Park, CA) was inserted through the periumbilical region and 1.5 to 2 L of CO2 was insufflated for pneumoperitoneum. After achieving pneumoperitoneum, a 1.7-mm microtelescope (Pixie-Needle scope, En View vision system; Origin Medsystems) was inserted through the Veress needle and the abdominal cavity was visualized. Two 5-mm cannulas were inserted through the right and left suprapubic regions for CO2 insufflation and for coagulation and cutting of fallopian tubes 2 to 3 cm distal to the cornual region with bipolar cutting forceps. Postoperatively, patients were observed in the hospital until they were stable. Amounts of local anesthetics and sedatives, operating time, quality of visualization (measured just before starting to coagulate the first tube, scored from +4 = best to +1 = worst), length of postoperative observation, intraoperative pain scores (determined with horizontal 10-cm visual analog scales just after tubes were cut), and postoperative analgesic and antiemetic requirements were recorded for both groups. Mann-Whitney U test was used for changing variables. Other values were analyzed by χ2 and Fisher’s exact tests where appropriate. Results were considered significant if probability was below 0.05.

Discussion With improvements in instruments and accessories, microlaparoscopy can be performed under local TABLE 1. Patients’ Clinical Features

Age (yrs) BMI (kg/m2) Gravidity Parity

CL (n = 10)

ML (n = 10)

pa

36.3 ± 1.49 24.92 ± 2.31 4.30 ± 1.05 2.50 ± 0.52

36.0 ± 2.26 24.81 ± 2.15 4.40 ± 0.84 3.30 ± 0.94

NS NS NS <0.05

CL = conventional laparoscopy; ML = microlaparoscopy; BMI = body mass index; NS = not significant. Values are mean ± SD. aMann-Whitney U test. TABLE 2. Mean Operating Time, Drugs Administered, and Intraoperative Pain Scores

Operating time (min) Postoperative observation (hrs) Bupivacaine dose (ml) Midazolam dose (mg) Fentanyl dose (µg) Intraoperative pain score

CL (n = 10)

ML (n = 10)

16.50 ± 9.27 3.61 ± 0.42

15.30 ± 5.27 3.70 ± 0.74

13.80 ± 2.89 7.60 ± 0.69 88.0 ± 17.51 3.7 ± 1.8

12.10 ± 2.92 8.05 ± 1.97 69.50 ± 27.93 3.1 ± 1.6

Values are mean ± SD. Probability was >0.05 for all variables by Mann-Whitney U test.

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procedures are also performed. Of 30 microlaparoscopies, 20 were diagnostic, 9 were for tubal sterilization, and 1 was zygote intrafallopian transfer.3 Seven women with documented ovarian cancer underwent second-look procedures and biopsies by microlaparoscopy under local anesthesia.10 Six of these operations were done in the office simply, safely, and effectively. Microlaparoscopy and conventional laparoscopy were compared in 37 patients with infertility, chronic pelvic pain, and desire for surgical sterilization.11 The authors concluded that microlaparoscopy might be preferred for tubal sterilization, biopsy, or fenestration of ovarian cysts, but it was less effective for scoring or managing adhesions, endometriosis, and infertility. The mean postoperative observation period was reported to be 2 to 4 hours after microlaparoscopy under local anesthesia and mild sedation.12 This is similar to the mean duration for our patients (3.7 hrs). Postoperative analgesic requirements were greater in women sterilized by conventional laparoscopy, probably due to larger umbilical incision. From 60% to 70% of women in both groups experienced retrograde amnesia. In the present study, quality of visualization was not significantly different from that with conventional laparoscopy. In a multicenter study, the quality was good in 85% of operations using microlaparoscopes with a diameter of 1.2 to 2 mm, but it was still worse than that with conventional laparoscopes.12 Microlaparoscopy under local anesthesia carries a lower risk of complications than conventional laparoscopy. Most complications during laparoscopy occur while inserting the Veress needle or cannula. Most serious are vessel and organ injuries when the 10-mm umbilical cannula is inserted. Microlaparoscopy might reduce the likelihood of such injuries because no large cannulas are used and insertion is done under direct vision. Complications due to the Veress needle have much lower mortality and morbidity. Microlaparoscopy is safer especially in women in whom intraabdominal adhesions are expected. The risk of CO2 embolus is also reduced.6 To our knowledge, this is the first published study to compare tubal sterilization by conventional laparoscopy and microlaparoscopy under local anesthesia and mild sedation. The latter seems to be an acceptable procedure and may be preferred.

TABLE 3. Postoperative Analgesic and Antiemetic Requirements and Retrograde Amnesia

Analgesic requirement Antiemetic requirement Retrograde amnesia

CL (n = 10)

ML (n = 10)

pa

7 (70) 2 (20) 7 (70)

1 (10) 0 6 (60)

0.02 NS NS

Values are number (%). NS = not significant. aFisher’s exact test. TABLE 4. Quality of Visualization During the Procedure

Visualization

CL (n = 10)

ML (n = 10)

+1 poor +2 fair +3 good +4 very good

0 0 2 (20) 8 (80)

0 1 (10) 5 (50) 4 (40)

Values are number (%).

anesthesia for both diagnostic and minor operative purposes.4 It is less invasive than conventional laparoscopy and can be performed under local anesthesia on an outpatient basis. Done in the office under local anesthesia, it was reported to be safe and effective in evaluating women for many different indications.7 To date, the procedure has been primarily performed in women with infertility or chronic pelvic pain and for tubal ligation. Ease of scheduling, reduced costs, and rapid recovery suggest that it may be the preferred initial procedure for these women. Most complications encountered during sterilization procedures are related to general anesthesia, which is why local anesthesia is preferred. Satisfactory results were achieved with sterilization performed by conventional laparoscopy under local anesthesia in 4500 subjects.8 In addition, local anesthetic might decrease the cost of the procedure 68% to 85%, based on a study of 2827 patients.2 In a series of 125 sterilizations by conventional laparoscopy 65 women were operated under local anesthesia.9 In that group operating time was shorter, postoperative pain and analgesic needs were less, and cost was less. Microlaparoscopy under local anesthesia is done mostly for diagnostic purposes, but minor surgical

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7. Palter SF: Office microlaparoscopy under local anesthesia. Obstet Gynecol Clin North Am 26:109–120, 1999

References 1. Pelland PC: Sterilization by laparoscopy. Clin Obstet Gynecol 26:321–323, 1983

8. Gupta SP: Experience in 4500 cases of laparoscopic sterilization Int Surg 78:76–78, 1993

2. Poindexter AN, Abdul-Malak M, Fast JE: Laparoscopic tubal sterilization under local anesthesia. Obstet Gynecol 75:5–8, 1990

9. Bordahl PE, Raeder JC, Nordenfoft J, et al: Laparoscopic sterilization under local or general anesthesia? A randomized study. Obstet Gynecol 81:137–141, 1993

3. Risquez F, Pennehouat G, Fernandez R, et al: Microlaparoscopy: A preliminary report. Hum Reprod 8:1701–1702, 1993

10. Childers JM, Hatch KD, Surwit EA: Office laparoscopy and biopsy for evaluation of patients with intraperitoneal carcinomatosis using a new optical catheter. Gynecol Oncol 47:337–342, 1992

4. Rísquez F: Microlaparoscopy: Indications and applications. In Fertility and Reproductive Medicine. Edited by RD Kempers, J Cohen, AF Hancy, et al. Amsterdam, Elsevier Science, 1998, pp. 71–84 5. Bauer O, Devroey P, Wisanto A, et al: Small diameter laparoscopy using a microlaparoscope. Hum Reprod 10:1461–1464, 1995

11. Karabacak O, Tıras MB, Taner ZT, et al: Small diameter versus conventional laparoscopy: A prospective, self-controlled study. Hum Reprod 10:2399–2401, 1997

6. Downing BG, Wood C: Initial experience with a new microlaparoscope 2 mm in diameter. Aust NZ J Obstet Gynaecol 35:202–204, 1995

12. Risquez F, Pennehoaut G, McCorvey R, et al: Diagnostic and operative microlaparoscopy: A preliminary multicenter report. Hum Reprod 12:1645–1648, 1997

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