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

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.

Study Overview

• Status: Recruiting
• Conditions: Deep Infiltrating Endometriosis
• Intervention / Treatment: Other: Endometriosis cohort

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: François GOLFIER, MD; Phone Number: +33 0478864179; Email: francois.golfier@chu-lyon.fr
• Study Contact Backup: Name: Alix SESQUES, MD; Email: alix.sesques@chu-lyon.fr

Study Locations

• France
  • Pierre-Bénite, France, 69495
    • Recruiting
    • Centre Hospitalier Lyon Sud
    • Sub-Investigator: Pierre-Adrien BOLZE, MD
    • Contact: François GOLFIER, MD; Phone Number: +33 0478864179; Email: francois.golfier@chu-lyon.fr
    • Contact: Alix SESQUES, MD; Email: alix.sesques@chu-lyon.fr
    • Principal Investigator: François GOLFIER, MD
    • Sub-Investigator: Alix SESQUES, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• surgically management for deep endometriosis

Exclusion Criteria:

• No surgical management necessary
• Isolated Adenomyosis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe endometriosis	Description of the study population : Socio-demographic data	5 years
Describe risk factors of the disease.	Postoperative complications (DINDO classification)	5 years
Describe diagnostic delay of the disease.	Description of diagnostic.	5 years
Describe diagnostic management of the disease.	Description of therapeutic management : Diagnostic loadings	5 years
Impact of the management of deep endometriosis on the use of assisted reproductive therapy.	Impact on fertility.	5 years
Describe risk factors of the disease.	Recurrence of endometriosis.	5 years

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2028

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 69HCL17_0813

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No