Quality of Life and Fertility of Patient With Deep Surgical Endometriosis: a Prospective Cohort

NCT ID: NCT03555903

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2028-02-29

Brief Summary

Endometriosis is a common gynaecologic disease affecting 5 to 15% women of reproductive age and up to 40% of infertile women. It is characterized by the presence of active endometrial tissue outside the uterine cavity, potentially causing invalidating chronic pelvic pain and infertility. It is therefore crucial to limit the progression and/or recurrence of the disease, and to improve the quality of life of affected women.

Deep infiltrating endometriosis (DIE), an advanced form of the disease, is defined by the invasion of an anatomical structure and organ close to the uterus (i.e. uterosacral ligament, rectovaginal space, recto-sigmoidal colon or bladder), or by a peritoneal invasion greater than 5mm. The management of DIE is unfortunately not yet based on high-level evidence data; it mainly depends on the localization of the disease, the extend of the invasion and the severity of the symptoms. In the absence of clear guidelines based on empirical data, the choice between surgical or medical treatment remains difficult and controversial.

To improve optimal DIE management, the investigators aim to create a prospective database reporting on DIE surgically treated in a teaching hospital in Lyon/France (Centre hospitalier universitaire Lyon Sud)

Data on known risks factors, symptoms (pain), quality of life, infertility history and disease management will be obtained using self-questionnaires, clinic, paraclinic, surgical and histological records as follow.

1. Each patient will be asked to fill in electronics protected on-line forms: the first one before surgery, followed by three follow-up forms at 1, 2 and 5 years after surgery.

2. The surgeon will be asked to fill in two electronic protected on-line forms: the first one at the time of surgery and the second one during a post-operative consultation (one month after surgery).

The questionnaires used in this study are similar to those used for the Endometriosis database "CIRENDO" (explain briefly what it is), which will ultimately allow us to pool the data from the 2 databases.

This French prospective study will advance the scientific knowledge on DIE surgical treatment and, by helping evaluate the impact of the surgery on the quality of life and fertility of affected women, will guide future recommendations for an optimal management of this invalidating disease.

Conditions

Deep Infiltrating Endometriosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endometriosis cohort

The aim of the study is to advance the scientific knowledge of deep infiltrating endometriosis (DIE) and to evaluate the impact of surgery on the quality of life and the fertility of affected women.

Endometriosis cohort

Intervention Type: OTHER

The investigator record data on risks factors, symptoms (pain), quality of life (using standardized quality of life questionnaires), infertility history, and management of the disease with a 5-years follow up.

Different surgical procedures exist to treat DIE and are they are described in the database, to allow comparison.

Interventions

Endometriosis cohort

The investigator record data on risks factors, symptoms (pain), quality of life (using standardized quality of life questionnaires), infertility history, and management of the disease with a 5-years follow up.

Different surgical procedures exist to treat DIE and are they are described in the database, to allow comparison.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• surgically management for deep endometriosis

Exclusion Criteria

• No surgical management necessary
• Isolated Adenomyosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre hospitalier Lyon sud

Pierre-Bénite, , France

Site Status: RECRUITING

Countries

France

Central Contacts

François GOLFIER, MD

Role: CONTACT

francois.golfier@chu-lyon.fr

0478864179 ext. +33

Alix SESQUES, MD

Role: CONTACT

alix.sesques@chu-lyon.fr

Facility Contacts

François GOLFIER, MD

Role: primary

francois.golfier@chu-lyon.fr

0478864179 ext. +33

Alix SESQUES, MD

Role: backup

alix.sesques@chu-lyon.fr

Other Identifiers

69HCL17_0813

Identifier Type: -

Identifier Source: org_study_id