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NCT Number: NCT03555903

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre hospitalier Lyon sud

Pierre-Bénite, 69495, France

Location status: Recruiting

Location contact

Alix SESQUES, MD

CONTACT

[email protected]

Alix SESQUES, MD

SUB_INVESTIGATOR

François GOLFIER, MD

CONTACT

[email protected]

0478864179 ext. +33

François GOLFIER, MD

PRINCIPAL_INVESTIGATOR

Pierre-Adrien BOLZE, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • surgically management for deep endometriosis

Exclusion criteria

  • No surgical management necessary
  • Isolated Adenomyosis

Treatment and study plan

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.

Primary outcomes

  1. The impact of the management of deep endometriosis on the quality of life

    Time frame: 5 years

    Evolution of SF 36 quality of life scores.

  2. The impact of the management of deep endometriosis on the quality of life

    Time frame: 5 years

    Evolution of EHP-30 quality of life scores.

Secondary outcomes

  1. Describe endometriosis

    Time frame: 5 years

    Description of the study population : Socio-demographic data

  2. Describe risk factors of the disease.

    Time frame: 5 years

    Postoperative complications (DINDO classification)

  3. Describe diagnostic delay of the disease.

    Time frame: 5 years

    Description of diagnostic.

  4. Describe diagnostic management of the disease.

    Time frame: 5 years

    Description of therapeutic management : Diagnostic loadings

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

    Time frame: 5 years

    Impact on fertility.

  6. Describe risk factors of the disease.

    Time frame: 5 years

    Recurrence of endometriosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Alix SESQUES, MD

CONTACT

[email protected]

François GOLFIER, MD

CONTACT

[email protected]

0478864179 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ENDORAA

Important dates

Study start
2018
Primary completion
2023
Study completion
2028
First posted
Jun 14, 2018
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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