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Completed

NCT Number: NCT05499884

Feasibility and Potential Aids of Intra-operative Endo-vaginal Ultrasound When Performing Rectal Shaving for Endometriosis

The protocol of this study consists in the inclusion of patients with endometriosic rectal involvement with a scheduled intervention. An endovaginal ultrasound will be performed in the operating room by the radiology team to confirm the operative indication of rectal shaving then in a second step a second ultrasound in the operating room will confirm the complete excision of the lesion or the case will allow to perform a more complete gesture (discoid or segmental resection) if the shaving is not sufficient with ultrasound and / or macroscopically

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Service DE CHIRURGIE GYNECOLOGIE CHU LILLE

Lille, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >18 years
  • Deep pelvic endometriosis with symptomatic rectal involvement
  • With surgical indication of rectal shaving validated in "RCP" or during the pre-operative consultation by the surgeon

Exclusion criteria

  • History of inflammatory digestive pathology

Treatment and study plan

Endovaginal ultrasound

Procedure

Endovaginal ultrasound will be performed in the operating room by the radiology team to:

  • to confirm the operative indication for a rectal shaving ;
  • to confirm the complete removal of the lesion

Primary outcomes

  1. Questioning the choice of surgical technique (performing a more complete procedure, such as discoid or segmental resection, immediately or after shaving)

    Time frame: during the procedure/surgery

    if endovaginal ultrasound performed in the operating room (before or after shaving) modifies the choice of surgical technique in at least 2 cases out of 10, the value of endovaginal ultrasound in the operating room in the management of rectal damage by shaving will be validated

Secondary outcomes

  1. anatomo-pathological analysis of the operating piece.

    Time frame: during the procedure/surgery

    The anatomo-pathological data will be available if the choice of surgical technique is modified following one of the endovaginal ultrasound scans carried out in the operating theatre - and therefore if a discoid or segmental resection is carried out. By confirming damage to the rectal mucosa and/or stenosis of the digestive lumen, these anatomo-pathological analyses will make it possible to validate the questioning of the choice of surgical technique.

    This information is thus complementary to the main evaluation criterion, by providing an external validity criterion.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: ECHOENDO

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2022
Registry last updated
Dec 26, 2025

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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