Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis (ENDO-SHAVING)

November 16, 2020 updated by: Fabio Barra, Ospedale Policlinico San Martino

Persistence of Rectal Endometriosis After Laparoscopic Shaving of Rectovaginal Endometriosis Infiltrating the Rectum

When performing shaving of a rectal endometriotic nodule, the surgeon can use the macroscopic appearance of the nodule and the tactile feedback provided by the laparoscopic instruments to decide the area of the bowel that needs to be excised. Theoretically, compared with segmental bowel resection, the shaving technique may expose the patients to a higher risk of persistence of intestinal endometriosis. The objective of this ultrasonographic study was to assess the risk of rectal endometriosis persistence following laparoscopic shaving of rectovaginal nodules.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genoa, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 underwent shaving of rectal endometriosis

Description

Inclusion Criteria:

  • patients underwent laparoscopic shaving of rectovaginal endometriosis infiltrating the rectum

Exclusion Criteria:

  • patients underwent previous bowel surgery (except appendectomy);
  • patients experienced postoperative complications (such as pelvic abscess, rectovaginal fistula, ureteral injuries)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women who underwent shaving for rectal endometriosis
Diagnostic test: Transvaginal ultrasound
Transvaginal ultrasonographic scan to diagnosis the recurrence of rectal endometriosis
Behavioral: 5-point Likert scale
Subjective scale to evaluate satisfaction to previous surgical treatment for rectal endometriosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with rectal recurrence of endometriosis
Time Frame: 3 months after the surgical approach
Evaluated by ultrasound
3 months after the surgical approach
Number of patients with rectal recurrence of endometriosis
Time Frame: 6 months after the surgical approach
Evaluated by ultrasound
6 months after the surgical approach

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction of patients to the previous surgical treatment
Time Frame: 3 months after the surgical approach
Evaluated by five-point Likert scale
3 months after the surgical approach
Volume of nodules in patients with rectal recurrence of endometriosis
Time Frame: 3 months after the surgical approach
Evaluated by ultrasound
3 months after the surgical approach
Satisfaction of patients to the previous surgical treatment
Time Frame: 6 months after the surgical approach
Evaluated by five-point Likert scale
6 months after the surgical approach
Volume of nodules in patients with rectal recurrence of endometriosis
Time Frame: 6 months after the surgical approach
Evaluated by ultrasound
6 months after the surgical approach

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Policlinico San Martino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO-SHAVING

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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