Quality of Life Assessment Before and After Essure Removal

NCT03401437 | Completed

• 1 other identifier: RECHMPL17_0154
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate quality of life before and after laparoscopic removal of the Essure® system. Women who complain about symptoms attributed to the Essure® device are expected to have an improved quality of life postoperatively.

Conditions

Patients Presenting Essure Device Attributed Symptoms

Keywords

adverse effects; Salpingectomy; Essure® device ablation; Cornual resection

Outcome Measures

Primary Outcomes (1)

• Improving the quality of life between pre and post-operative at 3 months

  The quality of life is measure with Short Form (36) Health Survey Questionnaire

  3 months after the surgery

Secondary Outcomes (5)

• General disorders and anxiety or depression

  One month before surgery and 3 months after surgery.

• Performance of 3D ultrasound

  Preoperatively

• Allergy to components

  Before removing the sterilization devices (Essure®)

• Allergy to components

  During surgical removal

• Defects in installation or secondary migration

  during surgery

Study Arms (2)

Retrospective cohorte

Patients seen in consultation between January 2017 and August 2017, who have already completed the SF-36 questionnaire (pre-operative, M1 and M3), the HAD and ANSM questionnaires (pre-operative and M3)

Prospective cohorte

Patients seen in consultation between August 2017

Behavioral: SF-36; Behavioral: HAD; Other: ANSM

Interventions

SF-36 BEHAVIORAL

Evaluation of the quality of life with an auto-questionnaire validated, with 8 dimensions: physical activity ; limitations due to physical condition; physical pain; perceived health; vitality; life and relationship with others; limitations due to physical condition; psychic health as well as the assessment of perceived health compared to a year ago. Evaluation done pre-operatively, at M1 and M3

Also known as: Short Form 36 Health Survey questionnaire

Prospective cohorte

HAD BEHAVIORAL

Evaluation of anxiety and depression with a scale validated with 14 items assess between 0 and 3. Evaluation done pre-operatively and at M3.

Also known as: Hospital Anxiety and Depression scale

Prospective cohorte

ANSM OTHER

Additional information requested by the ANSM (french National Agency for Medicines and Health Products Safety) following a materiovigilance report. Evaluation done pre-operatively and at M3.

Also known as: ANSM questionnaire

Prospective cohorte

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

Patient with definitive sterilization by Essure®

You may qualify if:

• Patients carrying Essure®
• Patients requesting surgical removal of Essure®
• Patients with adverse effect
• Being affiliated or benefiting from a French social security system

You may not qualify if:

• \- Patients with guardianship or curators

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• La Conception Hospital - Marseille - France: collaborator
• Public Assistance - Marseille Hospitals: collaborator
• Aix Marseille Université: collaborator

Study Sites (2)

Public Assistance - Marseille Hospitals

Marseille, 13005, France

Location

Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Study Officials

• PATRICE PC CROCHET, PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: January 17, 2018
• Study Start: January 10, 2017
• Primary Completion: January 31, 2018
• Study Completion: November 16, 2018
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

FR (2)