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

NCT03555903 | Recruiting

• 1 other identifier: 69HCL17_0813
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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. 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. 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).

Conditions

Deep Infiltrating Endometriosis

Outcome Measures

Primary Outcomes (2)

• The impact of the management of deep endometriosis on the quality of life

  Evolution of SF 36 quality of life scores.

  5 years

• The impact of the management of deep endometriosis on the quality of life

  Evolution of EHP-30 quality of life scores.

  5 years

Secondary Outcomes (6)

• Describe endometriosis

  5 years

• Describe risk factors of the disease.

  5 years

• Describe diagnostic delay of the disease.

  5 years

• Describe diagnostic management of the disease.

  5 years

• Impact of the management of deep endometriosis on the use of assisted reproductive therapy.

  5 years

Study Arms (1)

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.

Other: Endometriosis cohort

Interventions

Endometriosis cohort 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.

Endometriosis cohort

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

Patients surgically managed for deep endometriosis in Centre hospitalier Lyon sud, Lyon, France

You may qualify if:

• surgically management for deep endometriosis

You may not qualify if:

• No surgical management necessary
• Isolated Adenomyosis

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre hospitalier Lyon sud

Pierre-Bénite, 69495, France

RECRUITING

Central Study Contacts

François GOLFIER, MD

CONTACT

0478864179; francois.golfier@chu-lyon.fr

Alix SESQUES, MD

CONTACT

alix.sesques@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: June 14, 2018
• Study Start: May 1, 2018
• Primary Completion: February 1, 2023
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

FR (1)