Tubal ligation and survival of ovarian cancer patients.

AIM: The aim of the present study was to investigate associations between ovarian cancer survival and reproductive, gynecological and hormone factors. MATERIAL AND METHODS: A prospective follow-up study was conducted in the Southeast of China. The cohort comprised 202 patients with histopathologically confirmed epithelial ovarian cancer who were enrolled during 1999-2000 and followed-up for 5years subsequently. One hundred and ninety five (96.5%) of the cohort or their close relatives were traced. Information was obtained on reproductive, gynecological and hormone factors prior to diagnosis, actual survival time and number of deaths. Cox proportional models were used to estimate mortality hazard ratios (HR) and associated 95% confidence intervals (CI) for tubal ligation, adjusting for age at diagnosis, body mass index (BMI), menopausal status, International Federation of Gynaecology and Obstetrics (FIGO) stage, histological grade of differentiation, cytology of ascites, and chemotherapy status. RESULTS: The HR was significantly increased and survival was worse in ovarian cancer patients with a previous tubal ligation, but not with any other reproductive, gynecological and hormone factor. Only 21 (38.9%) of 54 patients who had tubal ligation survived to the time of interview, in contrast to 95 women (67.4%) still alive among the 141 women without tubal ligation (P<0.001). Compared to the patients who had no tubal ligation, the adjusted HR was 1.62 (95% CI 1.01-2.59; P=0.04) for those who had tubal ligation. There was no association with age at menarche, menopausal status, parity, breastfeeding, hormone replacement therapy, oral contraceptive use, and hysterectomy. CONCLUSION: Previous tubal ligation was an independently adverse prognostic factor for epithelial ovarian cancer survival. Further studies that examine the relationship are warranted to confirm these results.

Tubal sterilization, all-cause death, and cancer among women in the United Kingdom: evidence from the Royal College of General Practitioners' Oral Contraception Study.

OBJECTIVE: The purpose of this study was to examine the relationship between tubal sterilization and subsequent all-cause death and the risk of any gynecologic and breast cancer in women in the United Kingdom. STUDY DESIGN: A cohort study was conducted with 2801 sterilized women and 2801 nonsterilized women who were identified from the UK Royal College of General Practitioners' Oral Contraception Study. Adjusted hazard ratios and 95% CIs were calculated with Cox regression. RESULTS: Tubal sterilization was not associated with significantly altered risks of subsequent all-cause death or cancer. Tubal sterilization was associated with a nonsignificant reduced risk of subsequent gynecologic (adjusted hazard ratio, 0.84; 95% CI, 0.52-1.37) and breast cancer (adjusted hazard ratio, 0.88; 95% CI, 0.67-1.16). CONCLUSION: The absence of increased long-term death and cancer risk is reassuring, given that many women have chosen this method of contraception.

Laparoscopic sterilization.

Laparoscopic female sterilization is still the leading method of family planning for patients who have completed their family. Mechanical methods include clips and rings and are preferred because they are safe and efficient and can be used on a day case basis. Appropriate training ensures improved results with fewer complications. Clips and rings have an improved reversal potential.

Practice of standards in female sterilisation.

During training of trainers (TOT) courses organised for medical personnel of Haryana Civil Medical Services (HCMS) by COE Medical College, Rohtak, 55 doctors involved in female sterilisations were interrogated regarding practices in counselling, informed decision, asepsis, surgical procedure, operative and postoperative care and follow-up of the clients accepting sterilisation as contraception. Counselling was the responsibility of auxiliary nurse cum midwife (ANM) lady health volunteer (LHV)/other paramedical workers as viewed by 89.1% participants whereas 85.4% thought that the registration clerk should take the informed consent. Eligibility criteria were always adhered to by 10.9% participants. Asepsis and sterilisation of instruments, etc, were maintained by operation theatre (OT) attendant or OT nurse as answered by 90.9% doctors. Skin preparation was done by a solution containing cetrimide and chlorhexidine alone by 70.8% doctors. The ligation and excision was the method practised by all. Catgut suture was used by only 43.6% doctors. Twenty-six maternal deaths were reported by 20 participants during their whole career. There were 7 deaths on the table, all with laparoscopic sterilisation. Peritonitis with septicaemia was the major cause of death in majority of cases. To ensure high quality and safety of voluntary surgical contraception, programmes must establish a system to ensure that standards are maintained.

PIP: The quality and safety of voluntary surgical contraception in India were evaluated as part of a training of trainers course organized for medical personnel at Haryana Civil Medical Services. A total of 55 physicians, with a mean duration of 9.35 years spent performing female sterilizations, were surveyed regarding their practices related to counseling, informed decision making, asepsis, surgical procedures, operative and postoperative care, and client follow up. Respondents performed an average of 550 minilaparotomy tubectomies and 1250 laparoscopic sterilizations per year. 89.1% of physicians considered client counseling to be the responsibility of auxiliary nurse-midwives or paramedical workers, 85.4% believed the registration clerk should take informed consent, and 94.6% thought the general practitioner should perform the pre-operative evaluation. Only 10.9% of physicians adhered to sterilization eligibility criteria. Maintenance of asepsis was left to operation theater attendants by 91.9%. All physicians practiced ligation and excision. Most patients were discharged 2-4 hours after surgery. Only 9.1% of physicians provided patients with discharge instructions and follow-up was generally handled by community workers. Finally, 20 physicians (36.3%) had experienced a tubectomy-associated death at some point in their career. Peritonitis with septicemia was the cause of death in most of these cases. Overall, these findings indicate an urgent need to improve the safety of female sterilization in India by upgrading physician standards and expanding their responsibilities.

[Controversy on the method of sterilization during cesarean section: tubal ligation or hysterectomy? Review of the literature]. / Controverse sur la méthode de stérilisation au cours de la césarienne: ligature des trompes ou hystérectomie? Une revue de littérature.

The results of tubal ligation done during cesarean section are analysed in the context of a developing country during the last eleven years (1982-1992) at the maternity of the University Hospital Centre in Yaounde (Cameroun), ring this time there were 13,759 deliveries, of which 1,062 cases were by cesarean section with 109 cases of tubal ligation and 2 cases of cesarean hysterectomy. The operative and post-operative complications are discussed and compared to that in cesarean hysterectomy. Complications are found to be more in cases of cesarean hysterectomy that in cases of tubal ligation by cesarean section. The author conclude that hysterectomy at the time of cesarean section should be restricted to those cases in which removal of the uterus is necessary to preserve the life of the patient.

Camp laparoscopic sterilization deaths in Gujarat State, India, 1978-1980.

An early experience of camp laparoscopic sterilization in Gujarat State, India, resulted in 22 deaths among 106,500 women undergoing the operation during 1979 and 1980. Increased risk of death was seen when larger numbers of procedures were performed by year or month of year. The least experienced surgeons had the highest case-fatality rate. Improvised settings (i.e., school buildings) exacerbated the risk of death, as did advanced age, and, to a lesser extent, high parity. Errors in clinical judgment were identified in some fatal procedures. A system of health audit of large sterilization programs is needed.

PIP: A physician analyzed 1978-80 data on 22 laparoscopic deaths among 106,500 women who underwent sterilization at camps in Gujarat State in India to determine the programmatic and clinical risk factors in these camps. The death rate stood at 20.65/1000,000 procedures compared with 1.5/1000,000 for the US. The laparoscopic sterilization camps were set up in district hospitals, primary health centers, and school buildings. The leading causes of death were peritonitis (9), septicemia (4), and tetanus (2). 5 women also died on the operating table of lignocaine sensitivity (2), cardiac arrest (2), and air embolism (1). The death rate climbed with age (0 deaths for 25 year old, 17 for 26-30 year old, 25.2 for 31-35 year old, and 40.4 for 36-40 year old). It also increased with parity (11.9 for women with 2 living children and 29.8 for those with at least 5 children). 10 of the 22 sterilization deaths were women =or 30 years old with at least 4 children. The number of sterilizations grew 3-fold between 1979-80 and the risk of death grew almost 2-fold. The risk of deaths was especially high during the campaign season (December-March) indicating an increased risk of speedy completions to meet quotas. Surgeons with 6 months experience in laparoscopic sterilization were responsible for most deaths (67%) in camps with 50-100 sterilizations. The case fatality rate for these surgeons was 54.2/1000,000 compared with 8.1 for surgeons with at least 25 months, experience. The same percentage of deaths in these camps occurred to women operated on in school buildings. The case fatality rate for school building operations was 71/1000,000 compared with 15.4 for district hospitals and 13.5 for primary health centers. An unacceptable risk would remain even if school buildings were excluded and laparoscopic sterilization training would not occur at sterilization camps. Improved sterilization of equipment and improved surgical judgment of complications could have prevented many deaths. A medical audit of camps services is justified.

Meeting the need for female sterilisation.

PIP: The single most common form of fertility control world wide is voluntary sterilization. 130 million women and 50 million men are sterilized each year. In the US and the UK sterilization is used by most 30% of couples of reproductive age. Also, the mean age at which someone chooses sterilization is declining. The main point of this article is that because such a large volume of people are having this type of surgery, any improvements in technique or reduction in complication, even if it is an incremental change, is an improvement. In the US the case-fatality rate for tubal sterilization is 4/1,000,00, while in Bangladesh the rate if 19.3/100,000. However, it is estimated that 100,000 female sterilizations prevent 1000 maternal deaths in the years between surgery and menopause. Post sterilization pregnancies is another issue addressed by this article. Among 20,749 sterilizations reported by Family Health International, there were 209 pregnancies. 1/3 of these were luteal phase pregnancies that were undetected at the time of surgery. Preliminary studies suggest that failures are more common with mechanical clips than rings, bipolar cautery, or the Pomeroy technique. (Although the differences are small). In the US 75% of female sterilizations are done by bipolar electrocautery because of a perception that it has the lowest failure rate. Ectopic pregnancies occurred at a rate of 0.64/100,000 operations. There are two primary ways of entering the abdomen to occlude the fallopian tubes. Minilaparotomy is very common, requires minimal surgical skills and is safe and cheap for the patient because a local anesthetic can be used. Laparoscopic sterilization while being convenient is more complicated, requires a higher degree of surgical skill, and more expensive equipment. In well equipped, high volume areas, this method is preferred because of its convenience. However, with very few exceptions, it is not practical for field or rural areas. Family planning delivery systems must walk a fine line between having too few controls on access to sterilization, and thus subverting informed consent; and having too many controls, and thus denying access to the people who will benefit the most.^ieng

A total of 250,136 laparoscopic sterilizations by a single operator.

A total of 250,136 women were sterilized as outpatients by a single operator working with a team in ad hoc sterilization 'camps'. Falope rings were applied by the laparocator under local anaesthesia, with premedication but without vaginal manipulation (in all but the first 10,100). Volunteers were recruited and the operation discussed in nearby villages. The women were numbered at registration and arranged in groups, each comprised of two rows (odd or even numbers) of 15 women, leading to two improvised operating tables or benches in a steep Trendelenburg position. With good teamwork the number of women sterilized was generally 40 to 50/h. There were 12 associated deaths, not all attributable to the procedure, a mortality rate of 4.8 per 100,000; 8 major complications (3.2 per 100,000) required laparotomy or admission to hospital. In a follow-up survey of 84,940 responders to a questionnaire only 90 pregnancies (0.1%) were reported to have been conceived after the cycle of surgery. The results suggest that the rapid 'no exposure' technique as used in this series is safe and acceptable in an Indian context. If others could acquire this skill it could with appropriate adaptation make appreciable inroads into the unmet need for female sterilization in many other developing countries.

Case-fatality rates for tubal sterilization in U.S. hospitals, 1979 to 1980.

To update a 1977 to 1978 case-fatality estimate for tubal sterilization in U.S. hospitals, we reviewed the medical records of women reported by the Commission on Professional and Hospital Activities to have died after tubal sterilization procedures in 1979 or 1980. We project that the most reasonable case-fatality rate estimate is slightly greater than 9 per 100,000 sterilizations if all deaths associated with the procedure are considered. Rate estimates that assume minimum and maximum numbers of all associated deaths in our sample are approximately 6 per 100,000 and 10 per 100,000 sterilizations, respectively. However, when only deaths that can be attributed to sterilization per se are considered, the most reasonable case-fatality rate is estimated at between 1 and 2 per 100,000 procedures, a lower rate than previously reported. Rate estimates that assume minimum and maximum numbers of attributable deaths in our sample are approximately 1 per 100,000 and 5 per 100,000 sterilizations, respectively. These results further indicate that death attributable to tubal sterilization is rare.

PIP: The medical records of women reported by the US Commission on Professional and Hospital Activities to have died after tubal sterilization procedures in 1979-80 were reviewed to obtain current case-fatality estimates. The previous estimate, which used data from 1977 and 1978, was 3.6/100,000 procedures. The Commission identified 53 women who had tubal sterilization and who died during hospitalization; however, permission to review medical records was obtained for only 37 of these women. Of these 37 deaths, 28 were associated with sterilization and 9 involved coding errors. Of the 28 sterilization-associated deaths, 17 were attributable to concurrent cesarean section and 7 were attributable to other concurrent procedures. Of the 3 women whose deaths were clearly related to the sterilization procedure, 2 had no underlying illnesses and 1 had severe congenital heart disease (which may have contributed to her death). In the 4th case, the probable cause of death was intracranial hemorrhage caused by pregnancy-induced hypertension. The 28 sterilization-associated deaths occurred among a total population of 433,744 women who received tubal sterilizations in US hospitals in 1979 and 1980. Since 28 of the 37 deaths reviewed were associated with sterilization, it was assumed that 76% of the unreviewed deaths were sterilization-associated. This assumption results in a total number of 40 deaths and a case-fatality rate of 9.2/100,000 procedures. Use of the same procedure suggests a sterilization-attributable case-fatality rate of 1.5/100,000. In view of the small number of deaths involved, the decline in sterilization-attributable deaths from 1977-78 and 1979-80 should not be interpreted as a trend over time. However, these results confirm the belief that death attributable to tubal sterilization is a rare event.

[Reproductive mortality in Switzerland between 1952 and 1982]. / Reproduktive Mortalität in der Schweiz zwischen 1952 und 1982.

Reproductive mortality includes mortality attributable to pregnancy and childbirth and its sequelae, termination of pregnancy and contraception. The latter is mainly due to an increase of cardiovascular diseases in oral contraceptive users. An estimate of reproductive mortality in Switzerland is based on available figures on cardiovascular mortality, smoking and use of oral contraceptives. The reproductive mortality has been steadily declining since 1952 in the age group of 15-34, a stagnation of this risk can be observed for women over 35 since 1962. Theoretically this stagnation might be due to the use of oral contraceptives and an increase in smoking.

Mortality associated with sterilization: preliminary results of an international collaborative observational study.

Sterilization is the contraceptive method most widely used worldwide, yet the case-fatality rate of deaths attributable to sterilization is not known. We used data collected from 1971-1979 from 28 countries by Family Health International to estimate case-fatality rates. We adjusted these rates for individuals lost to follow-up. Of 41,834 sterilizations, 23 resulted in deaths temporally associated with the procedure used. The adjusted attributable case-fatality rates were 13.4 per 100,000 for interval procedures, 53.3 per 100,000 for postabortion procedures, and 43.4 per 100,000 sterilizations after vaginal delivery. Multiple factors contributed to the deaths, including pre-existing health problems, infection and anesthesia. Prevention of deaths resulting from sterilization depends on complete ascertainment of deaths associated with sterilization and careful investigation to determine preventable risk factors. We conclude that, overall, sterilization in these programs was conducted with very low attributable mortality.

PIP: Sterilization is the contraceptive method most widely used worldwide, yet the case-fatality rate of deaths attributable to sterilization is not known. In this study data was collected from 1971-79 from 28 countries by Family Health International to estimate case-fatality rates. Rates were adjusted for individuals lost to follow-up. Of 41,834 sterilizations, 23 resulted in deaths temporally associated with the procedure used. The adjusted attributable case-fatality rates were 13.4/100,000 for interval procedures, 53.3/100,000 for postabortion procedures, and 43.4/100,000 sterilizations after vaginal delivery. Multiple factors contributed to the deaths, including pre-existing health problems, infection and anesthesia. Prevention of deaths resulting from sterilization depends on complete ascertainment of deaths associated with sterilization and careful investigation to determine preventable risk factors. Overall, sterilization in these programs was conducted with very low attributable mortality.

[Complications of tubal sterilization]. / Komplikationen der Tubensterilisation.

PIP: In Europe and the US, tubal sterilization by laparoscopy has become the most widely used technique for female sterilization. The overall rate of intra- and postoperative complications differs between 0.145% and 0.85% in the numerous studies which have been done. This means 1 severe complication in 120-700 laparoscopic sterilizations. The lethality of tubal sterilization by laparoscopy lies between 3-10 deaths/100,000 interventions. The so-called "post-tubal ligation syndrome" is a rare complication. The overall pregnancy rate after tubal sterilization is 3-10/1000 women. The rate of ectopic pregnancy is very high and varies between 13.6% and 90%. Only 5% of the sterilized women show dissatisfaction. Several factors are relevant with regard to psychological sequelae and must be considered before tubal sterilization can be performed. 1 of the most important is the individual comprehensive counselling of the female or the couple prior to the sterilization.^ieng

Rare events associated with tubal sterilizations: an international experience.

The results from previous analyses of an international data set collected by Family Health International are reviewed in relation to the incidence, severity, risk factors, and outcomes of rare events associated with tubal sterilization. The rare events included for review, by sequence of their relationship to the tubal sterilization procedure are: luteal phase pregnancy, intraoperative complications (uterine perforation, unintended laparotomy required for completion of the laparoscopic procedure, and technical failure in tubal ring sterilization), deaths, early readmission following laparoscopic sterilization, hysterectomy after laparoscopic sterilization, and pregnancy (intrauterine and ectopic) conceived after tubal sterilization. The widespread use of this method of contraception has important public health implications, and awareness of these events will help clinicians minimize such incidences and better deal with them when they arise.

A comprehensive review of female sterilisation--tubal occlusion methods.

Female sterilisation using tubal occlusive methods are reviewed. The various techniques, failure rates, mortality, short and long-term morbidity, psychosexual effects and reversibility are discussed. Tubal occlusion is an effective method of female sterilisation but if failure should occur ectopic pregnancies are more likely if tubal diathermy, and less likely if Fallope rings or Filshie clips have been used for the original sterilisation procedure. Mortality rates are low and occur as a once-only risk when compared to ongoing contraception. Short-term morbidity rates are low when sterilisation is performed via the laparoscope, with single portal entry being more likely to result in complications. Mini-laparotomy and laparotomy also have low morbidity levels but complication rates are much higher when a transvaginal approach is used. There is no increase in morbidity when tubal sterilisation is performed at the time of pregnancy termination, providing uterine evacuation is not performed by hysterotomy. In the majority of cases no menstrual disturbance is noted; however, a small increase in menstrual disorders as a direct result of tubal sterilisation cannot be excluded absolutely. Sterilisation does not affect sexual satisfaction. Regret is more likely if the sterilisation is performed (i) post-termination or in the puerperium, (ii) when there is marital disharmony and (iii) for medical rather than social reasons. Low parity is not associated with regret except in cultures where high parity is prized. Microsurgical methods of reversal have higher pregnancy and lower ectopic rates than macrosurgical techniques. Successful reversal is inversely related to the degree of tubal destruction at the initial operation.

Comparative risks and costs of male and female sterilization.

Couples who are considering elective sterilization should compare the risks and costs of male and female sterilization procedures as part of the decision process. Morbidity, mortality, failure rates, and short-term costs associated with male and female sterilization procedures were estimated from data available in previous case series. Male sterilization procedures were found to have zero attributable deaths and significantly less major complications when compared to female sterilization procedures. No less than 14 deaths a year can be attributed to female sterilization procedures in the US. Male and female sterilization procedures have efficacy rates that are not significantly different from each other. The short-term costs of female sterilization are 3.0 to 4.1 times that of vasectomy.