Dataset Information

Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study.

ABSTRACT:

Objective

To compare the safety and efficacy of hysteroscopic sterilization with the "Essure" device with laparoscopic sterilization in a large, all-inclusive, state cohort.

Design

Population based cohort study.

Settings

Outpatient interventional setting in New York State.

Participants

Women undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013.

Main outcomes measures

Safety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis.

Results

We identified 8048 patients undergoing hysteroscopic sterilization and 44,278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization.

Conclusions

Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures should be discussed with patients for informed decisions making.

SUBMITTER: Mao J

PROVIDER: S-EPMC4604215 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceSafety of hysteroscopic sterilization has been recently questioned following reports of general symptoms such as allergy, tiredness, and depression in addition to associated gynecological results such as pelvic pain, perforation of fallopian tubes or uterus, and unwanted pregnancy.ObjectiveTo compare the risk of reported adverse events between hysteroscopic and laparoscopic sterilization.Design, setting, and participantsFrench nationwide cohort study using the national hospital discharge database linked to the health insurance claims database. Women aged 30 to 54 years receiving a first hysteroscopic or laparoscopic sterilization between 2010 and 2014 were included and were followed up through December 2015.ExposuresHysteroscopic sterilization vs laparoscopic sterilization.Main outcomes and measuresRisks of procedural complications (surgical and medical) and of gynecological (sterilization failure that includes salpingectomy, second sterilization procedure, or pregnancy; pregnancy; reoperation) and medical outcomes (all types of allergy; autoimmune diseases; thyroid disorder; use of analgesics, antimigraines, antidepressants, benzodiazepines; outpatient visits; sickness absence; suicide attempts; death) that occurred within 1 and 3 years after sterilization were compared using inverse probability of treatment-weighted Cox models.ResultsOf the 105 357 women included (95.5% of eligible participants; mean age, 41.3 years [SD, 3.7 years]), 71 303 (67.7% ) underwent hysteroscopic sterilization, and 34 054 (32.3%) underwent laparoscopic sterilization. During the hospitalization for sterilization, risk of surgical complications for hysteroscopic sterilization was lower: 0.13% for hysteroscopic sterilization vs 0.78% for laparoscopic sterilization (adjusted risk difference [RD], -0.64; 95% CI, -0.67 to -0.60) and was lower for medical complications: 0.06% vs 0.11% (adjusted RD, -0.05; 95% CI, -0.08 to -0.01). During the first year after sterilization, 4.83% of women who underwent hysteroscopic sterilization had a higher risk of sterilization failure than the 0.69% who underwent laparoscopic sterilization (adjusted hazard ratio [HR], 7.11; 95% CI, 5.92 to 8.54; adjusted RD, 4.23 per 100 person-years; 95% CI, 3.40 to 5.22). Additionally, 5.65% of women who underwent hysteroscopic sterilization required gynecological reoperation vs 1.76% of women who underwent laparoscopic sterilization (adjusted HR, 3.26; 95% CI, 2.90 to 3.67; adjusted RD, 4.63 per 100 person-years; 95% CI, 3.38 to 4.75); these differences persisted after 3 years, although attenuated. Hysteroscopic sterilization was associated with a lower risk of pregnancy within the first year of the procedure but was not significantly associated with a difference in risk of pregnancy by the third year (adjusted HR, 1.04; 95% CI, 0.83-1.30; adjusted RD, 0.01 per 100 person-years; 95% CI, -0.04 to 0.07). Risks of medical outcomes were not significantly increased with hysteroscopic sterilization compared with laparoscopic sterilization.Conclusions and relevanceAmong women undergoing first sterilization, the use of hysteroscopic sterilization was significantly associated with higher risk of gynecological complications over 1 year and over 3 years than was laparoscopic sterilization. Risk of medical outcomes was not significantly increased over 1 year or over 3 years. These findings do not support increased medical risks associated with hysteroscopic sterilization.

Project description:BackgroundOpen enucleation (OE) is often performed for giant liver hemangioma (LH) because of its advantage in maximum preservation of functional liver parenchyma. Laparoscopic enucleation (LE) has been applied to LHs more frequently for its potential advantages in postoperative recovery and blood loss. However, to date, LE is still a difficult and complex surgical technique especially when the hemangioma is located in the right hemi liver. The aim of this study was to analyze whether LE is superior to OE for LH in the right hemi liver.MethodsDemographics and perioperative data of patients who underwent LE or OE for LH in the right hemi liver between May 2013 and July 2020 were collected. To decrease the selection bias, patients who underwent OE in first 2 years and those underwent LE in next 5 years by a same operation team were included. The data of sex, age, body mass index (BMI), American Society of Anesthesiologists (ASA) score, largest tumor size, and removed tumor number were enrolled in the propensity score matching (PSM) method to compensate for differences in the baseline characteristics between LE and OE groups. The perioperative outcomes were compared between 2 matched groups after PSM method.ResultsA total of 110 patients (36 LE vs. 74 OE) were matched by age, sex, BMI, ASA grade score, largest tumor size, removed tumor number and tumor location. Finally, 34 patients in each group were retained after PSM. There were no significant differences in operative time, estimated blood loss, amount of autologous transfusion, morbidity grade and the levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) on postoperative day 1 or 3 or 5. LE was associated with a significantly higher rate of use of the Pringle maneuver (P<0.001), shorter time to oral feeding (P<0.001) and shorter postoperative length of stay (P<0.001).ConclusionsFor LHs in the right hemi liver, the perioperative safety of LE is not inferior to OE, and LE seems to achieves a faster recovery from surgery compared with OE.

Project description:Female sterilization is the second most commonly used method of contraception in the United States. Female sterilization can now be performed through laparoscopic, abdominal, or hysteroscopic approaches. The hysteroscopic sterilization may be a safer option than sterilization through laparoscopy or laparotomy because it avoids invading the abdominal cavity and undergoing general anaesthesia. Hysteroscopic sterilization mainly includes chemical agents and mechanical devices. Common issues related to the toxicity of the chemical agents used have raised concerns regarding this kind of contraception. The difficulty of the transcervical insertion of such mechanical devices into the fallopian tubes has increased the high incidence of device displacement or dislodgment. At present, Essure® is the only commercially available hysteroscopic sterilization device being used clinically. The system is irreversible and is not effective immediately.Our new hysteroscopic sterility system consists of nickel-titanium (NiTi) shape memory alloy and a waterproof membrane. The NiTi alloy is covered with two coatings to avoid toxic Ni release and to prevent stimulation of epithelial tissue growth around the oviducts. Because of the shape memory effect of the NiTi alloy, the device works like an umbrella: it stays collapsed at low temperature before placement and opens by the force of shape memory activated by the body temperature after it is inserted hysteroscopically into the interstitial tubal lumen. The rim of the open device will incise into interstitial myometrium during the process of unfolding. Once the device is fixed, it blocks the tube completely. When the patient no longer wishes for sterilization, the device can be closed by perfusing liquid with low temperature into the uterine cavity, followed by prospective hysteroscopic removal. After the device removal, the fallopian tube will revert to its physiological functions.Currently, experimental and clinical studies are needed to attest the safety, efficiency and reversibility of the novel sterilization device.If our hypothesis is confirmed, appropriate and reversible contraceptive can be achieved with the device we have designed, which may have significant repercussions for numerous women worldwide.