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

NCT ID: NCT05499884

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2024-07-15

Brief Summary

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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

Detailed Description

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Conditions

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Endometriosis

Keywords

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deep pelvic endometriosis rectal shaving segmental digestive resection endovaginal ultrasound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

Group Type EXPERIMENTAL

Endovaginal ultrasound

Intervention Type 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

Interventions

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Endovaginal ultrasound

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chrystele RUBOD, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Service DE CHIRURGIE GYNECOLOGIE CHU LILLE

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2022-A01264-39

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0273

Identifier Type: -

Identifier Source: org_study_id