Laparoscopic Essure Device Removal

NCT04779658 | Unknown

• 1 other identifier: RECHMPL21_0087
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, several symptoms have been attributed to Essure, including pelvic pain and other general symptoms. Consequently, an increasing number of patients request Essure removal for alleged adverse reactions to the device. Study Objective: To evaluate the quality of life of patients who underwent Essure\_ device removal and morbidity of this surgery. Design: Prospective observational cohort study. Setting: Academic hospitals of La Conception, Marseille, and Arnaud-de-Villeneuve, Montpellier, France. Patients: Women who underwent Essure\_ device removal by salpingectomy, between February 2017 and August 2018. Methods : The following information have been collected during preoperative clinics: demographic data, medical history, clinical symptoms attributed to the Essure device, time between Essure sterilization and early symptoms, time between the beginning of symptoms and surgical removal. Follow-up visits have benne scheduled at one month and three months post-operation. The evolution of symptoms was collected during the follow-up visit at three months based on clinical reports and a dedicated questionnaire. Evaluation of Quality of life have been evaluated thanks to SF36 and HAD questionnaires. Alle these patients will be contacted by phone call to assess to evolution of symptoms and to complete SF 36 and HAD questionnaires. Hypothesis : Recovery of symptoms due to ESSURE device and improvement of quality of life after surgery.

Conditions

Contraception

Keywords

Essure device removal; Quality of life

Outcome Measures

Primary Outcomes (2)

• Evaluation of quality of life after ESSURE removal

  Evaluation of quality of life after ESSURE removal by SF 36 questionnaire Preoperative questionnaires will be collected from medical record. Patients will be contacted by phone call to answer to this questionnaire for the long term follow-up

  Preoperative

• Evaluation of quality of life after ESSURE removal

  Evaluation of quality of life after ESSURE removal by SF 36 questionnaire three-months post-operative questionnaires will be collected from medical record. Patients will be contacted by phone call to answer to this questionnaire for the long term follow-up

  three-months post-operative

Secondary Outcomes (1)

• Evaluation of morbidity of ESSURE removal

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who underwent Essure\_ device removal by salpingectomy, between February 2017 and August 2018.

You may qualify if:

• age \>18 years old
• symptoms related to ESSURE device
• salpingectomy for ESSURE removal

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

Study Officials

• Martha DURAES, Md

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GAUTHIER RATHAT

CONTACT

467336421; g-rathat@chu-montpllier.fr

Martha DURAES, MD

CONTACT

631329158; duraesmartha@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: March 3, 2021
• Study Start: January 1, 2021
• Primary Completion: December 29, 2021
• Study Completion: December 30, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-02

Locations

FR (1)