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Complications of Interval Laparoscopic Tubal Sterilization: Findings From the United States Collaborative Review of Sterilization

From the Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia.

Address reprint requests to: Denise J. Jamieson, MD, MPH, Centers for Disease Control and Prevention, Women’s Health and Fertility Branch, Division of Reproductive Health, 1600 Clifton Road, Mail Stop E45, Atlanta, GA 30333, E-mail: djamieson7{at}cdc.gov

	Abstract

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Objective: To estimate the risk of intraoperative or postoperative complications for interval laparoscopic tubal sterilizations.

Methods: We used a prospective, multicenter cohort study of 9475 women who had interval laparoscopic tubal sterilization to calculate the rates of intraoperative or postoperative complications. The relative safety of various methods was assessed by calculating overall complication rates for each major method of tubal occlusion. Method-related complication rates also were calculated and included only complications attributable to a method of occlusion. We used logistic regression to identify independent predictors of one or more complications.

Results: When we used a more restrictive definition of unintended major surgery, the overall rate of complications went from 1.6 to 0.9 per 100 procedures. There was one life-threatening event and there were no deaths. Complications rates for each of the four major methods of tubal occlusion ranged from 1.17 to 1.95, with no significant differences between them. When complication rates were calculated, the spring clip method had the lowest method-related complication rate (0.47 per 100 procedures), although it was not significantly different from the others. In adjusted analysis, diabetes mellitus (adjusted odds ratio [OR] 4.5; 95% confidence interval [CI] 2.3, 8.8), general anesthesia (OR 3.2; CI 1.6, 6.6), previous abdominal or pelvic surgery (OR 2.0; CI 1.4, 2.9), and obesity (OR 1.7; CI 1.2, 2.6) were independent predictors of one or more complications.

Conclusion: Interval laparoscopic sterilization generally is a safe procedure; serious morbidity is rare.

Tubal sterilization is one of the most common operations in women,¹ with more than 600,000 in the United States each year.² Many healthy women have tubal sterilizations electively, so it is important to characterize associated mortality and morbidity. In 1978, the Centers for Disease Control and Prevention (with subsequent support from the National Institute of Child Health and Human Development) initiated a multicenter prospective study of surgical sterilization. A major aim was to evaluate the relative safety of various tubal sterilization operations in the United States. In 1983 and 1987, interim analyses summarized intraoperative and postoperative complications among women who had interval laparoscopic tubal sterilizations.^3,4 However, inadequate numbers precluded a comparison of safety of various methods of tubal occlusion. Using data from the completed investigation, we have expanded our preliminary reports by including all women enrolled in the study and reporting complication rates by method of occlusion.

	Materials and Methods

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The methods of the United States Collaborative Review of Sterilization were reported.⁵ Eligible women were 18–44 years old who were scheduled for tubal sterilizations in 15 participating institutions in nine cities from 1978 to 1987. Trained interviewers attempted to contact all eligible women to request participation. Approval for this study was granted by the institutional review board at each institution and participants signed informed consent forms. Among 12,138 women enrolled, the current analysis was restricted to 9475 women who had interval laparoscopic procedures. We also excluded women who had concurrent surgeries other than diagnostic D&C or simple biopsies.

An interviewer obtained detailed medical and contraceptive histories from each participant before the sterilization. Details of each procedure, including complications, were recorded during admission. Follow-up information was obtained in telephone interviews at 1 month and 1 year afterward.

We examined many potential predictors of intraoperative and postoperative complications. Types of anesthesia included local, without a general or regional anesthetic agent; regional, including spinal, caudal, or epidural anesthesia; or general, if used during the entire procedure. We also considered as predictors race, age, lung disease (asthma, bronchitis, or emphysema), obesity (body mass index [BMI] of 30 kg/m² or greater), recent or current oral contraceptive (OC) use (within 3 months before sterilization), diabetes mellitus, previous abdominal or pelvic surgery, history of pelvic inflammatory disease, gravidity, history of cardiovascular disease, history of ovarian cysts, intended method of tubal occlusion at the initiation of surgery, number of previous induced abortions, smoking history, history of leiomyomata, recent use of intrauterine device, level of education, and study site.

We chose six standard complication categories that are objective, represent events expected to increase morbidity and mortality, and were used in previous analyses of intraoperative and postoperative complications:³ Unintended major surgery: Any laparotomy, repair of perforated viscus, or repair of major blood vessel done intraoperatively or postoperatively during the same hospitalization that was not planned and was related to the tubal sterilization;

Transfusion: Any intraoperative or postoperative blood transfusion;

Febrile morbidity: Oral temperature of 38C or higher on at least 2 postoperative days, excluding the first 24 hours after surgery;

Life-threatening event: Any intraoperative or postoperative cardiac or respiratory arrest, myocardial infarction, pulmonary embolus, anaphylactic shock, or disseminated intravascular coagulation;

Rehospitalization: Readmission to the hospital between discharge and first follow-up interview because of a complaint or problem the woman perceived as related to tubal sterilization; and

Death: Death or complication leading to death within 42 days after surgery.

All cases of unintended major surgery required laparotomy; no perforated viscus or major blood vessel repairs were done laparoscopically. Unintended major surgery was subdivided to specify laparotomy indication. Those subdivisions included true laparoscopic complications (unexpected bleeding, hematoma formation, viscus perforation, and fallopian tube transection), difficulty with tubal occlusion (difficulty with visibility or movement of at least one fallopian tube or with the intended method on at least one fallopian tube), failed pneumoperitoneum or abdominal-pelvic cavity entry, incidental disease found at laparoscopy that required laparotomy, equipment malfunction, and unknown. To assign subdivisions, two authors (DJJ and HBP) reviewed independently the enrollment forms of each woman in the unintended surgery category and classified complications in one of the six subdivisions. The authors discussed and reached a consensus on the three cases on which they did not agree initially.

Besides overall complication rates, standard rates were calculated by intended method at initiation of surgery for the four most frequent methods of occlusion: bipolar coagulation, unipolar coagulation, silicone rubber band application, and spring clip application. We determined that a sample of 2241 women in each of the four intended method groups was needed to have 90% power to detect a twofold increase and 80% power to detect a twofold decrease of complications relative to each group, with = 0.05. In some cases, the final method of occlusion differed from the intended method. In cases in which the intended and final methods differed and in which there were complications, two authors (DJJ and HBP) assessed whether it was reasonable to attribute the complication to the intended method. To calculate complication rates attributable to methods of occlusion, they reviewed available information for women with standard complications. A complication was classified as method-related if it was plausibly related to method of occlusion and there was insufficient information to assign another likely cause. In 19 of 153 cases the authors did not agree initially and reached a consensus.

To analyze potential risk factors that might affect complication rates, we calculated unadjusted odds ratios (ORs). We did adjusted analyses to correct for potential confounding; the multiple logistic regression model included all variables that were significant at P .2 in univariate analysis with no elimination of factors. In calculating unadjusted and adjusted ORs, we included only women who had one of the four major methods of occlusion.

	Results

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Most participants were white and 25 to 34 years old. Thirty-four percent were black. Nearly 80% had at least high school educations (Table 1) and only 3.5% were nulliparous.

The reasons for rehospitalization of 56 women were pelvic infections (n = 16), heavy vaginal bleeding (n = 7), pregnancy complication (n = 7), abdominal or pelvic pain (n = 5), tubal sterilization completion by laparotomy (n = 2), chest pain (n = 2), urinary tract infection (n = 2), unrelated diseases found during tubal sterilization (n = 2), neurologic symptoms (n = 2), peritonitis caused by bowel burn (n = 1), bronchitis (n = 1), depression (n = 1), infected intravenous catheter site (n = 1), appendicitis (n = 1), poorly controlled diabetes (n = 1), bowel obstruction (n = 1), lost clip (n = 1), and unknown (n = 3). In two cases, rehospitalization was probably caused by complications of concurrent procedures and not tubal sterilizations. In one of those cases, a rectovaginal abscess was biopsied during sterilization and the woman re-presented with a biopsy site infection. The other woman had a D&C during sterilization and presented with vaginal bleeding caused by cervical laceration. In seven cases of pregnancy complications, all were luteal phase. Four were intrauterine, two were incomplete abortions, and one was ectopic. In the case of the lost clip, a clip dropped into the pelvis could not be found intraoperatively. Postoperatively, physicians saw the clip in the pelvic radiographically and decided that, because the clip was open, it should be removed. She was readmitted and the clip was removed.

Among 13 febrile women, five had urinary tract infections, two had septicemia, and six had no known causes. One woman who had laparotomy required intra-operative transfusion. The only life-threatening event was anaphylaxis, presumably caused by anesthesia.

Among all participants, there were no deaths within 42 days of surgery. Five women died within 1 year, one each from brain tumor, leukemia, murder, cerebral aneurysm rupture, and unknown. It is unlikely that the unknown cause of death was related to sterilization because the woman died 5 months after surgery and was well at the 1-month follow-up visit.

The overall standard complication rate was 1.6 per 100 procedures. With a more restrictive definition for the unintended major surgery complication category, which included the contribution of the 14 true laparoscopic complications and excluded the other causes of unintended major surgery, the overall standard complication rate was 0.9 complications per 100 procedures.

Among the four main methods of occlusion, the spring clip had the lowest complication rate (1.17 standard complications per 100 procedures and 0.47 method-related complications per 100 procedures), which were not significantly different from the other methods (Table 3). The study did not have adequate power to detect possible clinically significant differences in complication rates between some methods. For example, the study had inadequate power (60%) to detect a twofold difference in complication rates between the spring clip and unipolar coagulation methods, but had adequate power (80–90%) to detect a twofold difference in complication rates between silicone rubber band and bipolar coagulation.

Among the four bowel injuries, one laparotomy was needed because of difficult peritoneal cavity entry. Although that woman’s postoperative hospital course was unremarkable, she was readmitted 11 days after surgery because of a bowel obstruction, which physicians treated conservatively. The second case was the presumed thermal bowel injury. The other two cases were one small bowel perforation and one stomach perforation found intraoperatively. Both needed laparotomies for repair.

Risk factors identifiable before surgery associated with increased risk of one or more standard complications in adjusted analyses were diabetes mellitus, general anesthesia, previous abdominal or pelvic surgery, and obesity (Table 4). Abdominal or pelvic adhesions found intraoperatively was a statistically significant risk factor for one or more complications (adjusted OR 3.3; 95% CI 2.3, 4.7).

	Discussion

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The most frequent complication was unintended surgery, which accounted for more than half of standard complications reported. However, some conversions to laparotomy represent appropriate treatment of disease (eg, extensive adhesions or incidental abnormalities) and are not complications of sterilization. We calculated the overall standard complication rate and used a restrictive definition for unintended surgery to calculate a more conservative estimate. There might be disagreement about which laparotomies are designated complications, but these two estimates provide minimum and maximum standard complication rates.

This study lacked adequate power to detect meaningful differences in complication rates among some of the four major methods of occlusion. Although 95% CIs overlapped with other methods, spring clip application had the lowest standard and method-related complication rates. Pregnancy risk is higher with spring clip application than other methods.⁵

We had low power to detect rare but important complications such as vessel lacerations or thermal bowel injuries. For example, two reviews of procedures in France and the United Kingdom in the 1970s suggested major vessels were lacerated in three to nine per 10,000 laparoscopies.^6,7 None were observed in this study. Likewise, a review of thermal bowel injuries in the 1970s estimated 0.5 per 1000 unipolar coagulating procedures.⁸ Our only thermal bowel injury is consistent with reports that suggested risk is greater with unipolar than bipolar coagulating systems.⁹ In cases in which tubal transection was the reason for subsequent laparotomy, intended method of occlusion was silicone rubber band.

Women with diabetes mellitus, previous abdominal or pelvic surgery, or obesity and those who had procedures under general anesthesia had increased complication risks. These risk factors were reported from interim analyses for the first 3500 women enrolled in that study.³ General anesthesia was associated with higher complication rates than local anesthesia in randomized trials.^10,11 Although history of pelvic inflammatory disease (PID) generally is considered a risk for adhesive disease, thus complications,³ self-reported PID was not a risk factor for complications in our study. Patient self-report might be unreliable as an indicator for PID. In our study adhesions found during surgery predicted complications.

Other factors affect the reported complication rates. Continued advances in laparoscopy might reduce conversions to laparotomies and difficulty with fallopian tubes might now be treated laparoscopically. In the first half of our study, most women (58%) stayed in the hospital for at least 1 night. In the second half of our study, most women (97%) left the hospital on the day of surgery. In the first half, there were 11 cases of febrile morbidity; in the second half, there were two. Women discharged from the hospital on the day of surgery are not routinely instructed to monitor their temperatures at home, so our febrile morbidity rates are probably underestimated. However, if febrile morbidity led to clinically significant complications, it is likely that some of those women were rehospitalized and counted in the rehospitalization rate. Rehospitalization might have been overestimated because some hospitalizations shortly after procedures might not have been caused by sterilization. For example, in two cases with concurrent procedures (biopsy of rectovaginal abscess and D&C), complications were most likely caused by the other procedures. Pregnancy complications in the six luteal phase cases that required hospitalization probably would have happened regardless of sterilization. Standard definitions might have underestimated complication rates by excluding some that did not fall into those categories. In our preliminary report a sensitivity analysis compared the standard complications with a more extensive listing, and the standard categories detected more than 90% of women who had potentially serious complications.³

	Footnotes

 
The U.S. Collaborative Review of Sterilization Working Group: Design, Coordination, and Analysis Center: Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. Principal Investigator: Herbert B. Peterson, MD; Project Officer: Joyce M. Hughes; Project Associates: Zhisen Xia, PhD, Lynne S. Wilcox, MD, Lisa Ratliff Tylor; Project Consultant: James Trussell, PhD; Data Collection Centers Project Directors: Norman G. Courey, MD, CM, State University of New York at Buffalo, Erie County Medical Center, Buffalo, New York; Philip D. Darney, MD, MSc, University of California, San Francisco, San Francisco, California; Ernst R. Friedrich, MD, Washington University School of Medicine, St. Louis, Missouri; Ralph W. Hale, MD, Roy T. Nakayama, MD, Kapiolani Medical Center, Honolulu, Hawaii; Jaroslav F. Hulka, MD, University of North Carolina School of Medicine, Chapel Hill, North Carolina; Alfred N. Poindexter, MD, Baylor College of Medicine; George M. Ryan, MD, Edwin M. Thorpe, MD, University of Tennessee School of Medicine, Memphis, Tennessee; Gary K. Stewart, MD (deceased), Planned Parenthood of Sacramento, Sacramento, California; Howard A. Zacur, MD, Lucas Blanco, MD, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Supported by an interagency agreement (3-Y02-HD41075-10) with the National Institute of Child Health and Human Development.

PII S0029-7844(00)01082-6

Received May 12, 2000. Received in revised form July 11, 2000. Accepted September 13, 2000.

	References

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1. Owings MF, Kozak LJ. Ambulatory and inpatient procedures in the United States, 1996. Vital Health Stat 1998;139:1–119.

2. Schwartz DB, Wingo PA, Antarsh L, Smith JC. Female sterilization in the United States, 1987. Fam Plann Perspect 1989;21:209–12.[Medline]

3. DeStefano F, Greenspan JR, Dicker RC, Peterson HB, Strauss LT, Rubin GL. Complications of interval laparoscopic tubal sterilization. Obstet Gynecol 1983;61:153–8.[Abstract/Free Full Text]

4. Franks AL, Kendrick JS, Peterson HB. Unintended laparotomy associated with laparoscopic tubal sterilization. Am J Obstet Gynecol 1987;157:1102–5.[Medline]

5. Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J. The risk of pregnancy after tubal sterilization: Findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol 1996;174:1161–8.[Medline]

6. Mintz M. Risks and prophylaxis in laparoscopy: A survey of 100,000 cases. J Repro Med 1977;18:269–72.

7. Chamberlain G, Brown JC, eds. Gynaecological laparoscopy: The report of the Confidential Enquiry into Gynaecological Laparoscopy. London: Royal College of Obstetricians and Gynaecologists, 1978:114.

8. Phillips JM, Keith D, Hulka J, Hulka B, Keith L. Gynecologic laparoscopy in 1975. J Reprod Med 1976;16:105–17.[Medline]

9. Centers for Disease Control and Prevention. Deaths following female sterilization with unipolar electrocoagulating devices. MMWR Morb Mortal Wkly Rep 1981;30:149–51.[Medline]

10. Bordahl PE, Raeder JC, Nordentoft J, Kirste U, Refsdal A. Laparoscopic sterilization under local or general anesthesia? A randomized study. Obstet Gynecol 1993;81:137–41.[Abstract/Free Full Text]

11. Peterson HB, Hulka JF, Spielman FJ, Lee S, Marchbanks PA. Local versus general anesthesia for laparoscopic sterilization: A randomized study. Obstet Gynecol 1987;70:903–8.[Medline]

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