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

NCT05499884 | Completed

• 2 other identifiers: 2021_02732022-A01264-39
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometriosis

Keywords

deep pelvic endometriosis; rectal shaving segmental digestive resection; endovaginal ultrasound

Outcome Measures

Primary Outcomes (1)

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

  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

  during the procedure/surgery

Secondary Outcomes (1)

• anatomo-pathological analysis of the operating piece.

  during the procedure/surgery

Study Arms (1)

Experimental group

EXPERIMENTAL

Procedure: Endovaginal ultrasound

Interventions

Endovaginal ultrasound PROCEDURE

Endovaginal ultrasound will be performed in the operating room by the radiology team to: 1. to confirm the operative indication for a rectal shaving ; 2. to confirm the complete removal of the lesion

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients with scheduled surgery for pelvic endometriosis with rectal involvement
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of inflammatory digestive pathology

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Service DE CHIRURGIE GYNECOLOGIE CHU LILLE

Lille, France

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Chrystele RUBOD, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 12, 2022
• Study Start: April 3, 2023
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)