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Sterilization by open laparoscopy in a private office
August 1997, Vol. 4, No. 4
TheJournal of the American Association of Gynecologic Laparoscopists
Sterilization by Open Laparoscopy in a Private Office Fred W. Schnepper, M.D.
Abstract Between December 4, 1979, and September I, 1996, I performed 813 laparoscopic sterilizations in my private office setting. To increase safety and reduce costs, open laparoscopy was done under local anesthesia in every case. The procedure was completed in 811 women. There were no major complications. Minor complications consisted of three superficial wound infections and two failed laparoscopies. (l Am AssocGynecol Laparosc4(4):469-472, 1997)
used in every case. Patient acceptance of, and even preference for, the office procedure is evident by the large number of women who chose this setting over the hospital surgical unit.
In the United States and most developed countries, laparoscopic tubal sterilization has been limited almost entirely to hospital-based surgical units or to outpatient surgicenters. Although many gynecologic procedures have moved from the surgical unit to the private office, gynecologists have been reluctant to expand this to include laparoscopy. This is largely for two reasons. First is the potential for catastrophic injury. Major vessel injury, gas embolism, and anesthetic accidents are difficult to manage even in the most sophisticated operating room; in a private office they would mean almost certain death. ~ 3 Second is the notion that women would not tolerate laparoscopy under local anesthesia. Recently, however, interest in office laparoscopy under local anesthesia has increased.4, 5 Between December 4, 1979, and September 1, 1996, I performed 813 laparoscopies in an office setring. To eliminate or minimize the risk of catastrophic injuries, open laparoscopy and local anesthesia were
Materials and Methods
Patient Selection Private patients who requested sterilization were offered the option of having the procedure performed in the office under local anesthesia or in the hospital under local or general anesthesia. The office procedure was not offered to women with significant medical problems. Of women requesting the office procedure, only three were refused, one because of a history of extensive pelvic adhesions and two because of marked obesity (>270 lbs). Because excessive weight, especially involving the neck and facial structures, is associated with airway problems, the heaviest woman on whom
From the South Bay Women's Health Group, Chula Vista, and Department of Reproductive Medicine, University of California, San Diego, California. Address reprint requests to Fred W. Schnepper, M.D., 480 Fourth Avenue, Suite 412, Chula Vista, CA 91910; fax 619 422 7660. Presented at the 25th annual meeting of the American Association of Gynecologic Laparoscopists, Chicago, Illinois, September 24--29, 1966.
469
Office Laparoscopic Sterilization Schnepper
the office procedure was performed weighed 250 pounds.
sion was made in the skin. This was usually transverse but was vertical in obese women. Allis clamps were attached to the skin edges to assist in traction. The subcutaneous tissue was bluntly dissected down to the fascia. The fascia was infiltrated with lidocaine solution 5 to 10 ml. The fascia was grasped with two Kocher clamps and elevated, and a small incision was made between the clamps. The tip of a Mayo clamp was inserted into the fascial incision, which was bluntly enlarged by spreading the jaws of the clamp. Each leaf of the fascia was tagged with a no. 0 polyglycolic acid suture. The peritoneum was opened bluntly. The Hasson cannula was inserted into the incision and secured by the fascial sutures. Since nitrous oxide causes less discomfort than carbon dioxide, 12-15it was the gas used to establish pneumoperitoneum. The laparoscope was introduced and the pelvic structures were identified. Each fallopian tube was sprayed with 5 to 10 ml of lidocaine. Sterilization was then accomplished by placing Hulka clip or silastic band, or by bipolar electrocoagulation. Of these techniques, the Hulka clip was the best tolerated and the easiest to perform under local anesthesia. Bipolar coagulation caused more discomfort during the procedure but the least discomfort during recovery. The silastic band caused the most discomfort, particularly during recovery. Now that the Filshie clip has been approved, plans are in place to include this option in future procedures. A three-burn technique on each tube was used with bipolar electrocoagulation, 16or two Hulka clips were placed on each tube. These precautionary steps were taken because of concern that sterilization failure might be blamed on the office procedure and local anesthesia. Reports of a higher than expected pregnancy rate with the Hulka clip and bipolar coagulation suggest this precaution may have been advantageous. On completing sterilization, the laparoscope was removed, nitrous oxide gas expressed, and fascia approximated with a no. 0 polyglycolic acid suture. The skin was then closed. Intravenous access was maintained throughout the procedure and until the patient was fully recovered and discharged.
Facilities and Equipment The facilities consisted of a minor surgery room, measuring 10 x 15 feet. Patients recovered here or, when two or more procedures were performed in sequence, in one of the office examination rooms. An operating laparoscope was used in every case. Additional equipment consisted of Hasson cannula, Serum gas-regulator system, nitrous oxide gas, flberoptic light projector and cable, Wolf bipolar generator, Kleppinger bipolar forceps, Hulka clip applicator, silastic band applicator, baby Deaver retractors, operating table capable of Trendelenburg position, scissors, needle holder, and an assortment of clamps. Immediately available were oxygen, suction, and a cart containing basic and advanced airway management equipment, pharmacologic antagonists, and emergency drugs. A nurse assisted with the surgery, and a circulating nurse helped monitor the patient and assist with minor tasks. Monitoring consisted of measuring blood pressure and continuous dialogue with the patient. Pulse oximetry was not available in 1979 at the onset of this series, but is now an integral part of patient monitoring. 6
Local Anesthesia and Analgesia The local anesthetic was lidocaine hydrochloride 1% with epinephrine. Epinephrine helps maintain a bloodless field, which is useful when doing open laparoscopy, and prolongs the effect of the lidocaine sprayed on the fallopian tubes. The maximum amount of lidocaine hydrochloride used was 40 ml or 400 mg. Analgesia consisted of a solution of fentanyl 0.1 mg and atropine 0.4 mg given intravenously. Fentanyl's short duration of action suits the procedure well and shortens postoperative recovery. Atropine blocks a potential vasovagal reaction. 7 10
Technique The technique of open laparoscopy was essentially as described elsewhere. 11 After preparing the abdomen with povidine-iodine, fentanyl 0.1 mg and atropine 0.4 mg were given intravenously. A Hulka tenaculum was attached to the cervix and uterus. The inferior fold of the umbilicus was anesthetized with approximately 10 ml lidocaine solution. A small inci-
Results Of 815 women requesting laparoscopic sterilization, 2 changed their minds about having the procedure
470
August 1997, Vol. 4, No. 4
The journal of the American Association of Gynecologic Laparoscopists
under local anesthesia. The first reconsidered after intravenous fentanyl was given and she realized she would not be more heavily sedated. She later had laparoscopic sterilization in the hospital under general anesthesia. In the second patient, several attempts to start an intravenous line were unsuccessful. She never scheduled hospital sterilization and was lost to follow-up. Of the remaining 813 women, the operation was completed successfully in 811. Two laparoscopies could not be completed. One was in an obese patient with a thick lower abdominal midline scar. Attempts to identify and open the fascia were unsuccessful and the procedure was discontinued. A vertical skin incision would most likely have made this surgery possible. The skin, fascia, and peritoneum all come together in the umbilicus. By using a vertical incision it is possible to cut directly down on the fascia and avoid becoming lost in a "sea" of subcutaneous fat? 7 The second discontinuation was in a patient with extensive small bowel adhesions that completely obscured the lower abdomen and pelvis. The hour spent unsuccessfully trying to circumvent these adhesions is a tribute to the tolerance some women have for this operation under local anesthesia. In the entire series one known failure to achieve sterilization resulted in an ectopic pregnancy; however, follow-up has been inadequate to draw any conclusion about this apparently low pregnancy rateJ 8
for immediate harm, and patients can be transported to a major operating facility in a timely fashion. 23 25 The results of this series indicate that female sterilization by open laparoscopy under local anesthesia is a suitable procedure for the private office setting when appropriate monitoring is done and safety precautions are in place.
References 1. Katz M, Beck P, Tancer ML: Major vessel injury during laparoscopy: Anatomy of two cases. Am J Obstet Gynecol 135:544-545, 1979 2. Cunanan RG, Courey NG, Lippes J: Complications of laparoscopic tubal sterilization. Obstet Gynecol 55: 501-506, 1980 3. Wadhiva RK: Gas embolism during laparoscopy. Anesthesiology 48(1):74-76, 1978 4. Love BL, McCorvey R, McCorvey M: Low-cost laparoscopic sterilization. J Am Assoc Gynecol Laparosc 1(4):379-381, 1994 5. Palter SF: Moving laparoscopy into the office. OBG Manage Sept. 27-30, 1995 6. Hulka JF: Anesthesiology. In Textbook of Laparoscopy. Orlando, FL, Grune & Stratton, 1985, pp 55-59 7. Fishburne JI: Office laparoscopic sterilization with local anesthesia. J Reprod Med 18(5):233-234, 1977
Complications
8. Poindexter AN: Laparoscopic sterilization under local anesthesia. Obstet Gynecol 75:5-8, 1990
No major complications occurred. No patients required hospitalization. Minor complications consisted of three superficial wound infections. These responded to local treatment and oral antibiotics. Two of the infections occurred early in the series, between the fortieth and fiftieth operations. All of these women were obese (>240 lbs), which prolonged the procedures. Using the vertical incision in obese women has shortened operating time and thus decreased the risk of infection.
9. Brantley JC: Cardiovascular collapse during laparoscopy: A report of two cases. Am J Obstet Gynecol 159:735-737, 1988 10. American Society of Anesthesiologists Task Force: Practice guidelines for sedation and analgesia by nonanesthesiologists. Anesthesiology 84(2):459-471, 1994 11. Hasson HM: Open laparoscopy. In Laparoscopy. Edited by JM Phillips. Baltimore, Williams & Wilkins, 1977, pp 145-149
Discussion Major risks of laparoscopy that have precluded its acceptance as a safe office procedure are anesthetic accidents, major vessel injury, and gas embolism. 19-22 These risks are minimized or eliminated by using local anesthesia and performing open laparoscopy. Although other risks remain, they have less potential
471
12. Phillips RS: Mechanism of improved patient tolerance to nitrous oxide in diagnostic laparoscopy. Am J Gastroenterol 82:143-144, 1987 13. Sharp JR, Pierson WE Brady CE: Comparison of CO2 and N20 induced discomfort during peritoneoscopy under local anesthesia. Gastroenterology 82:453456, 1982
Office Laparoscopic Sterilization Schnepper
14. Minoli G, Terruzi U, Spinzi GC, et al: The influence of carbon dioxide and nitrous oxide on pain during laparoscopy: A double-blind, controlled trial. Gastroenterol Endosc 28:173-175, 1982
20. Hurd WW, Bude RD, DeLancey DO, et al: The relationship of the umbilicus to the aortic bifurcation: Implications for laparoscopic technique. Obstet Gynecol 80:48-51, 1992
15. Uhlich GA: Laparoscopy, the question of the proper gas [editorial]. Gastroenterol Endosc 28:212-213, 1982
21. Ostman PL, Pantie-Fisher FH, Faure EA, et al: Circulatory collapse during laparoscopy. J Clin Anesth 2:129-132, 1990
16. Kleppinger RK: Laparoscopy tubal sterilization. In Current Therapy in Surgical Gynecology, 1st ed. Edited by CR Garcia, JJ Mikuta, NJ Rosenblum. Philadelphia, BC Decker, 1987, pp 80-86
22. YuzpeAA: Pneumoperitoneum needle and trocar injuries in laparoscopy. J Reprod Med 35:485-490, 1990
17. Hasson HM: Window for open laparoscopy [letter]. Am J Obstet Gynecol 137:869-870, 1980
23. Penfield AJ: How to prevent complications of open laparoscopy. J Reprod Med 30:660-663, 1985
18. Peterson HB, Xia Z, Hughes JM, et al: The risk of pregnancy after tubal sterilization: Findings from the U.S. collaborative review of sterilization. Am J Obstet Gynecol 174(4): 1161-1170, 1996
24. Bhiwandiwald PR Mumford SD, Kennedy KI: Comparison of the safety of open and conventional laparoscopy sterilization. Obstet Gyneco166:391-394, 1985
19. Hynes SR, Marhsall RL: Venous gas embolism during gynaecological laparoscopy. Can J Anaesth 39: 748-749, 1992
25. Hasson HM: Open laparoscopy vs closed laparoscopy: A comparison of complication rates. Adv Planned Parenthood 13:41-50, 1978
472
TheJournal of the American Association of Gynecologic Laparoscopists
Sterilization by Open Laparoscopy in a Private Office Fred W. Schnepper, M.D.
Abstract Between December 4, 1979, and September I, 1996, I performed 813 laparoscopic sterilizations in my private office setting. To increase safety and reduce costs, open laparoscopy was done under local anesthesia in every case. The procedure was completed in 811 women. There were no major complications. Minor complications consisted of three superficial wound infections and two failed laparoscopies. (l Am AssocGynecol Laparosc4(4):469-472, 1997)
used in every case. Patient acceptance of, and even preference for, the office procedure is evident by the large number of women who chose this setting over the hospital surgical unit.
In the United States and most developed countries, laparoscopic tubal sterilization has been limited almost entirely to hospital-based surgical units or to outpatient surgicenters. Although many gynecologic procedures have moved from the surgical unit to the private office, gynecologists have been reluctant to expand this to include laparoscopy. This is largely for two reasons. First is the potential for catastrophic injury. Major vessel injury, gas embolism, and anesthetic accidents are difficult to manage even in the most sophisticated operating room; in a private office they would mean almost certain death. ~ 3 Second is the notion that women would not tolerate laparoscopy under local anesthesia. Recently, however, interest in office laparoscopy under local anesthesia has increased.4, 5 Between December 4, 1979, and September 1, 1996, I performed 813 laparoscopies in an office setring. To eliminate or minimize the risk of catastrophic injuries, open laparoscopy and local anesthesia were
Materials and Methods
Patient Selection Private patients who requested sterilization were offered the option of having the procedure performed in the office under local anesthesia or in the hospital under local or general anesthesia. The office procedure was not offered to women with significant medical problems. Of women requesting the office procedure, only three were refused, one because of a history of extensive pelvic adhesions and two because of marked obesity (>270 lbs). Because excessive weight, especially involving the neck and facial structures, is associated with airway problems, the heaviest woman on whom
From the South Bay Women's Health Group, Chula Vista, and Department of Reproductive Medicine, University of California, San Diego, California. Address reprint requests to Fred W. Schnepper, M.D., 480 Fourth Avenue, Suite 412, Chula Vista, CA 91910; fax 619 422 7660. Presented at the 25th annual meeting of the American Association of Gynecologic Laparoscopists, Chicago, Illinois, September 24--29, 1966.
469
Office Laparoscopic Sterilization Schnepper
the office procedure was performed weighed 250 pounds.
sion was made in the skin. This was usually transverse but was vertical in obese women. Allis clamps were attached to the skin edges to assist in traction. The subcutaneous tissue was bluntly dissected down to the fascia. The fascia was infiltrated with lidocaine solution 5 to 10 ml. The fascia was grasped with two Kocher clamps and elevated, and a small incision was made between the clamps. The tip of a Mayo clamp was inserted into the fascial incision, which was bluntly enlarged by spreading the jaws of the clamp. Each leaf of the fascia was tagged with a no. 0 polyglycolic acid suture. The peritoneum was opened bluntly. The Hasson cannula was inserted into the incision and secured by the fascial sutures. Since nitrous oxide causes less discomfort than carbon dioxide, 12-15it was the gas used to establish pneumoperitoneum. The laparoscope was introduced and the pelvic structures were identified. Each fallopian tube was sprayed with 5 to 10 ml of lidocaine. Sterilization was then accomplished by placing Hulka clip or silastic band, or by bipolar electrocoagulation. Of these techniques, the Hulka clip was the best tolerated and the easiest to perform under local anesthesia. Bipolar coagulation caused more discomfort during the procedure but the least discomfort during recovery. The silastic band caused the most discomfort, particularly during recovery. Now that the Filshie clip has been approved, plans are in place to include this option in future procedures. A three-burn technique on each tube was used with bipolar electrocoagulation, 16or two Hulka clips were placed on each tube. These precautionary steps were taken because of concern that sterilization failure might be blamed on the office procedure and local anesthesia. Reports of a higher than expected pregnancy rate with the Hulka clip and bipolar coagulation suggest this precaution may have been advantageous. On completing sterilization, the laparoscope was removed, nitrous oxide gas expressed, and fascia approximated with a no. 0 polyglycolic acid suture. The skin was then closed. Intravenous access was maintained throughout the procedure and until the patient was fully recovered and discharged.
Facilities and Equipment The facilities consisted of a minor surgery room, measuring 10 x 15 feet. Patients recovered here or, when two or more procedures were performed in sequence, in one of the office examination rooms. An operating laparoscope was used in every case. Additional equipment consisted of Hasson cannula, Serum gas-regulator system, nitrous oxide gas, flberoptic light projector and cable, Wolf bipolar generator, Kleppinger bipolar forceps, Hulka clip applicator, silastic band applicator, baby Deaver retractors, operating table capable of Trendelenburg position, scissors, needle holder, and an assortment of clamps. Immediately available were oxygen, suction, and a cart containing basic and advanced airway management equipment, pharmacologic antagonists, and emergency drugs. A nurse assisted with the surgery, and a circulating nurse helped monitor the patient and assist with minor tasks. Monitoring consisted of measuring blood pressure and continuous dialogue with the patient. Pulse oximetry was not available in 1979 at the onset of this series, but is now an integral part of patient monitoring. 6
Local Anesthesia and Analgesia The local anesthetic was lidocaine hydrochloride 1% with epinephrine. Epinephrine helps maintain a bloodless field, which is useful when doing open laparoscopy, and prolongs the effect of the lidocaine sprayed on the fallopian tubes. The maximum amount of lidocaine hydrochloride used was 40 ml or 400 mg. Analgesia consisted of a solution of fentanyl 0.1 mg and atropine 0.4 mg given intravenously. Fentanyl's short duration of action suits the procedure well and shortens postoperative recovery. Atropine blocks a potential vasovagal reaction. 7 10
Technique The technique of open laparoscopy was essentially as described elsewhere. 11 After preparing the abdomen with povidine-iodine, fentanyl 0.1 mg and atropine 0.4 mg were given intravenously. A Hulka tenaculum was attached to the cervix and uterus. The inferior fold of the umbilicus was anesthetized with approximately 10 ml lidocaine solution. A small inci-
Results Of 815 women requesting laparoscopic sterilization, 2 changed their minds about having the procedure
470
August 1997, Vol. 4, No. 4
The journal of the American Association of Gynecologic Laparoscopists
under local anesthesia. The first reconsidered after intravenous fentanyl was given and she realized she would not be more heavily sedated. She later had laparoscopic sterilization in the hospital under general anesthesia. In the second patient, several attempts to start an intravenous line were unsuccessful. She never scheduled hospital sterilization and was lost to follow-up. Of the remaining 813 women, the operation was completed successfully in 811. Two laparoscopies could not be completed. One was in an obese patient with a thick lower abdominal midline scar. Attempts to identify and open the fascia were unsuccessful and the procedure was discontinued. A vertical skin incision would most likely have made this surgery possible. The skin, fascia, and peritoneum all come together in the umbilicus. By using a vertical incision it is possible to cut directly down on the fascia and avoid becoming lost in a "sea" of subcutaneous fat? 7 The second discontinuation was in a patient with extensive small bowel adhesions that completely obscured the lower abdomen and pelvis. The hour spent unsuccessfully trying to circumvent these adhesions is a tribute to the tolerance some women have for this operation under local anesthesia. In the entire series one known failure to achieve sterilization resulted in an ectopic pregnancy; however, follow-up has been inadequate to draw any conclusion about this apparently low pregnancy rateJ 8
for immediate harm, and patients can be transported to a major operating facility in a timely fashion. 23 25 The results of this series indicate that female sterilization by open laparoscopy under local anesthesia is a suitable procedure for the private office setting when appropriate monitoring is done and safety precautions are in place.
References 1. Katz M, Beck P, Tancer ML: Major vessel injury during laparoscopy: Anatomy of two cases. Am J Obstet Gynecol 135:544-545, 1979 2. Cunanan RG, Courey NG, Lippes J: Complications of laparoscopic tubal sterilization. Obstet Gynecol 55: 501-506, 1980 3. Wadhiva RK: Gas embolism during laparoscopy. Anesthesiology 48(1):74-76, 1978 4. Love BL, McCorvey R, McCorvey M: Low-cost laparoscopic sterilization. J Am Assoc Gynecol Laparosc 1(4):379-381, 1994 5. Palter SF: Moving laparoscopy into the office. OBG Manage Sept. 27-30, 1995 6. Hulka JF: Anesthesiology. In Textbook of Laparoscopy. Orlando, FL, Grune & Stratton, 1985, pp 55-59 7. Fishburne JI: Office laparoscopic sterilization with local anesthesia. J Reprod Med 18(5):233-234, 1977
Complications
8. Poindexter AN: Laparoscopic sterilization under local anesthesia. Obstet Gynecol 75:5-8, 1990
No major complications occurred. No patients required hospitalization. Minor complications consisted of three superficial wound infections. These responded to local treatment and oral antibiotics. Two of the infections occurred early in the series, between the fortieth and fiftieth operations. All of these women were obese (>240 lbs), which prolonged the procedures. Using the vertical incision in obese women has shortened operating time and thus decreased the risk of infection.
9. Brantley JC: Cardiovascular collapse during laparoscopy: A report of two cases. Am J Obstet Gynecol 159:735-737, 1988 10. American Society of Anesthesiologists Task Force: Practice guidelines for sedation and analgesia by nonanesthesiologists. Anesthesiology 84(2):459-471, 1994 11. Hasson HM: Open laparoscopy. In Laparoscopy. Edited by JM Phillips. Baltimore, Williams & Wilkins, 1977, pp 145-149
Discussion Major risks of laparoscopy that have precluded its acceptance as a safe office procedure are anesthetic accidents, major vessel injury, and gas embolism. 19-22 These risks are minimized or eliminated by using local anesthesia and performing open laparoscopy. Although other risks remain, they have less potential
471
12. Phillips RS: Mechanism of improved patient tolerance to nitrous oxide in diagnostic laparoscopy. Am J Gastroenterol 82:143-144, 1987 13. Sharp JR, Pierson WE Brady CE: Comparison of CO2 and N20 induced discomfort during peritoneoscopy under local anesthesia. Gastroenterology 82:453456, 1982
Office Laparoscopic Sterilization Schnepper
14. Minoli G, Terruzi U, Spinzi GC, et al: The influence of carbon dioxide and nitrous oxide on pain during laparoscopy: A double-blind, controlled trial. Gastroenterol Endosc 28:173-175, 1982
20. Hurd WW, Bude RD, DeLancey DO, et al: The relationship of the umbilicus to the aortic bifurcation: Implications for laparoscopic technique. Obstet Gynecol 80:48-51, 1992
15. Uhlich GA: Laparoscopy, the question of the proper gas [editorial]. Gastroenterol Endosc 28:212-213, 1982
21. Ostman PL, Pantie-Fisher FH, Faure EA, et al: Circulatory collapse during laparoscopy. J Clin Anesth 2:129-132, 1990
16. Kleppinger RK: Laparoscopy tubal sterilization. In Current Therapy in Surgical Gynecology, 1st ed. Edited by CR Garcia, JJ Mikuta, NJ Rosenblum. Philadelphia, BC Decker, 1987, pp 80-86
22. YuzpeAA: Pneumoperitoneum needle and trocar injuries in laparoscopy. J Reprod Med 35:485-490, 1990
17. Hasson HM: Window for open laparoscopy [letter]. Am J Obstet Gynecol 137:869-870, 1980
23. Penfield AJ: How to prevent complications of open laparoscopy. J Reprod Med 30:660-663, 1985
18. Peterson HB, Xia Z, Hughes JM, et al: The risk of pregnancy after tubal sterilization: Findings from the U.S. collaborative review of sterilization. Am J Obstet Gynecol 174(4): 1161-1170, 1996
24. Bhiwandiwald PR Mumford SD, Kennedy KI: Comparison of the safety of open and conventional laparoscopy sterilization. Obstet Gyneco166:391-394, 1985
19. Hynes SR, Marhsall RL: Venous gas embolism during gynaecological laparoscopy. Can J Anaesth 39: 748-749, 1992
25. Hasson HM: Open laparoscopy vs closed laparoscopy: A comparison of complication rates. Adv Planned Parenthood 13:41-50, 1978
472