Dataset Information

Quality of life after laparoscopic removal of Essure® sterilization devices.

ABSTRACT: Objectives:To assess changes in quality of life after laparoscopic removal of Essure® sterilization devices (Bayer AG, Leverkusen, Germany). Study Design:In this prospective observational study in an academic research hospital, 80 women with new or worsening symptoms since placement of Essure® sterilization devices undergoing subsequent surgical removal were included. Laparoscopic removal of Essure® devices and salpingectomy with or without cornual excision were performed. Concomitant uterine procedures could be associated where indicated for gynaecological complaints. Comparison using the T student test for coupled series was done in this before-and-after study. Results:Health related quality of life (HRQL) was the primary outcome measured by the Short Form 12 (SF-12) questionnaire and a global 10?cm visual analogue scale (VAS). Secondary outcomes included assessment of pain, using continuous (VAS) and ordinal scales (Modified McGill Pain Questionnaire), menstrual bleeding (pictorial blood loss assessment chart (PBAC) score) and surgical feasibility and safety. There was a significant improvement in quality of life in both mental and physical health aspects of the SF-12 (34.02 (+/-1.19) vs. 49.61 (+/-1.42, P?

SUBMITTER: Chene G

PROVIDER: S-EPMC6687440 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Quality of life after laparoscopic removal of Essure<sup>®</sup> sterilization devices.

Chene Gautier G Cerruto Emanuele E Moret Stephanie S Lebail-Carval Karine K Chabert Philippe P Mellier Georges G Nohuz Erdogan E Lamblin Gery G Clark T Justin TJ

European journal of obstetrics & gynecology and reproductive biology: X 20190520

<h4>Objectives</h4>To assess changes in quality of life after laparoscopic removal of Essure<sup>®</sup> sterilization devices (Bayer AG, Leverkusen, Germany).<h4>Study design</h4>In this prospective observational study in an academic research hospital, 80 women with new or worsening symptoms since placement of Essure<sup>®</sup> sterilization devices undergoing subsequent surgical removal were included. Laparoscopic removal of Essure<sup>®</sup> devices and salpingectomy with or without cornual ...[more]

PMID: 31404292

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Project description:BackgroundThe SarQoL® questionnaire was specifically designed to measure quality of life (QoL) in sarcopenia. Frailty and sarcopenia have areas of overlap, notably weak muscle strength and slow gait speed, which may mean that the SarQoL could provide a measure of QoL in frailty. This study aimed to evaluate the clinimetric properties of the SarQoL questionnaire in physical frailty using the Fried criteria.MethodsAnalyses were carried out on data from the Sarcopenia and Physical impairment with advancing Age study. Frailty was assessed with the Fried criteria and QoL with the SarQoL, the Short-Form 36-Item, and the EuroQoL 5-Dimension (EQ-5D) questionnaires. We evaluated discriminative power (with the Kruskal-Wallis analysis of variance test), internal consistency (with Cronbach's alpha), construct validity (through hypotheses testing), test-retest reliability (with the intraclass correlation coefficient), measurement error (calculating standard error of measurement and smallest detectable change), and responsiveness (through hypotheses testing and standardized response mean).ResultsIn total, 382 participants were included for the validation and 117 for the responsiveness evaluation. They had a median age of 73 (69-79) years, took 5 (3-8) drugs, and had 4 (3-5) co-morbidities. There were more women (n = 223; 58.4%) than men and, in total, 172 (45%) robust, 167 (44%) pre-frail, and 43 (11%) frail participants. Discriminative power was confirmed when significantly lower (P < 0.001) overall SarQoL scores, and thus also worse QoL, were observed between robust [77.1 (64.35-85.90)], pre-frail [62.54 (53.33-69.57)], and frail [49.99 (40.45-56.06)] participants. Six of the SarQoL domains performed likewise, with significantly lower scores according to frailty status with Domain 7 (fears) being the exception. Internal consistency was good (α = 0.866). Convergent (using Short-Form 36-Item and EQ-5D) and divergent construct validity (using EQ-5D) was confirmed. Test-retest reliability was excellent [intraclass correlation coefficient = 0.918 (0.834-0.961)], with a standard error of measurement of 3.88 and a smallest detectable change of 10.76 points. We found moderate responsiveness when five of the nine hypotheses were confirmed, coupled with a large effect size for the overall SarQoL score (corrected standardized response mean of -1.44).ConclusionsThe SarQoL questionnaire has adequate clinimetric properties for use with frail patients in clinical practice and trials and could provide data that are more appropriate and detailed than the generic questionnaires currently used.

Project description:ObjectiveTo compare the safety and efficacy of hysteroscopic sterilization with the "Essure" device with laparoscopic sterilization in a large, all-inclusive, state cohort.DesignPopulation based cohort study.SettingsOutpatient interventional setting in New York State.ParticipantsWomen undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013.Main outcomes measuresSafety 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.ResultsWe 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.ConclusionsPatients 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.

Project description:AimIt is commonly thought that laparoscopic surgery leads to faster postoperative recovery for its low invasiveness. We evaluated postoperative quality of life (QOL) after laparoscopic myomectomy (LM) by using the Euro-QOL 5 dimension (EQ-5D) score and analyzed its relationship to surgical factors.MethodsBetween 2014 and 2016, 541 patients underwent LM at our institution. We included 86 patients in the final analysis (16% response rate) who replied to the EQ-5D questionnaire, in order to investigate postoperative QOL. We evaluated patients' EQ-5D score before the operation and on the 3rd, 7th, 14th, 21st and 28th postoperative day (POD). We investigated the degree of correlation between the EQ-5D score and four surgical characteristics (operation time, intraoperative bleeding, number of resected myomas and weight of specimen). We examined correlation between EQ-5D scores and chief complaints such as hypermenorrhea, dysmenorrhea, other pain, myoma enlargement, palpable tumor and desire for childbearing. We also examined correlation between EQ-5D scores and other factors such as patient's age, infertility, history of abdominal surgery, marriage and body mass index.ResultsFull recovery, defined as an EQ-5D score of 1.0, was reported 2.3% of patients by POD3, 18.6% by POD7, 58.1% by POD14, 73.3% by POD21 and 86.0% by POD28. Longer duration of operation correlated weakly with poor recovery on POD3. Intraoperative bleeding, number of resected myomas and weight of the specimen did not significantly influence EQ-5D score. There was no correlation between chief complaints or other factors mentioned above and EQ-5D score.ConclusionsMore than a half of the patients undergoing LM included in our study reported full recovery of QOL after 2 weeks. The time to recover QOL was slightly influenced by the operation time. However, when LM was finished without any complications, postoperative QOL eventually seemed to improve regardless of the surgical characteristics such as operation time, intraoperative bleeding, number of resected myomas and weight of specimen.

Project description:Background: Mesioangular impacted mandibular third molar is a common dental anomaly, for which surgical extraction is required. Post-surgery closure of mucosa reduces the prevalence of pain and other surgery-associated complications. We compared tissue reaction/inflammation after 3 and 7 days of mucosal closure with Trusilk ® and Mersilk ® silk sutures, following impacted mandibular third molar removal. Methods: This multicenter, prospective, two-arm, parallel-group, randomized (1:1), single-blind study (July 2020-November 2021) included subjects (Trusilk ®, n=65 and Mersilk ®, n=64), requiring mucosal suturing following impacted mandibular third molar removal. The primary endpoint, incidence of pain, swelling and trismus at the extraction area on post-surgery day 3 and 7 was evaluated. The secondary endpoints, incidence of tissue reaction, wound infection, suture loosening, other complications, operative time, amount of anesthesia, intraoperative suture handling, time needed for complete wound healing and suture removal, and adverse events were also recorded. Results: Socio-demographic and intra-oral characteristics were comparable between the groups. In Trusilk ® and Mersilk ® groups, a gradually decreasing pain score, starting from day 0 post-surgery (42.17±22.38 vs. 45.97±22.20) to day 7 (8.40±11.93 vs. 8.28±12.13) to day 30 (1.98±0.89 vs. 1.75±0.76) was witnessed. After the surgery, 21.54% and 17.19% subjects in Trusilk ® and Mersilk ® groups, respectively, had no post-operative swelling, while at the last two visits none of the subjects had swelling. Non-significant difference in wound infection, suture loosening, wound healing, bleeding, taste changes, operative time, amount of anesthesia, intraoperative suture handling, and time needed for complete wound healing and suture removal was noted among the groups. No suture-related adverse events were recorded. Conclusions: The results indicated that the Trusilk ® and Mersilk ® silk sutures are clinically equivalent and can be used for mucosal closure after removal of an impacted mandibular third molar with a minimal rate of pain, swelling and trismus. Clinical Trial Registry of India Registration: CTRI/2020/03/024100 (20/03/2020).

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Quality of life after laparoscopic removal of Essure® sterilization devices.

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Quality of life after laparoscopic removal of Essure<sup>®</sup> sterilization devices.

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