Long-term Results of the Stapled Transanal Rectal Resection (STARR) Operation Proposed in the Treatment of a Rectocele (STARRLOC)

January 2, 2024 updated by: University Hospital, Grenoble

Single-center Retrospective Study of the Long-term Results of the Stapled TransAnal Rectal Resection (STARR) Operation Proposed in the Treatment of a Rectocele in Consecutive Patients

Rectal static disorders, including the rectocele, represent a frequent functional pathology which affects the quality of life of affected patients. Among vaginal treatments, the STARR technique corresponds to rectal resection by transanal approach using a stapler. The American Gastroenterology Association (AGA) has concluded that service to patients is insufficient. The technical and functional results published are mostly short-term studies. The investigators seek to assess the technical and functional results of Operation STARR, based on a series of consecutive expert center cases, to confirm or refute the conclusions of the AGA recommendations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

77

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Grenoble, France
        • Recruiting
        • CHU Grenoble Alpes, Service de chirurgie digestive et de l'urgence
        • Contact:

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

N/A

Sampling Method

Non-Probability Sample

Study Population

All adult patients operated on for rectocele in the digestive surgery and emergency department of the CHU de Grenoble will be included, provided they are not opposed.

Description

Inclusion Criteria:

  • Patient operated for rectocele for 10 or more
  • Age 18 and over
  • Informed patients

Exclusion Criteria:

  • Patient objection

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: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term results of the STARR operation.
Time Frame: 10 years
Dyschezia postoperatively
10 years

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Luc Faucheron, MD, CHU Grenoble Alpes

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)

October 16, 2021

Primary Completion (Estimated)

October 24, 2024

Study Completion (Estimated)

November 24, 2024

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 8, 2021

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC21.144

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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