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

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ClinicalTrials.gov Identifier: NCT05037422
Recruitment Status : Recruiting
First Posted : September 8, 2021
Last Update Posted : January 3, 2024
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Rectocele; Female Procedure: STARR surgery

Study Design
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Study Type : Observational
Estimated Enrollment : 77 participants
Observational Model: Other
Time Perspective: Other
Official Title: 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
Actual Study Start Date : October 16, 2021
Estimated Primary Completion Date : October 24, 2024
Estimated Study Completion Date : November 24, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: STARR surgery
    This intervention is carried out under general anesthesia or spinal anesthesia. It consists of the circular resection of the "surplus" of rectal mucosa. Rectal resection and suturing is performed using automatic mechanical forceps introduced through the anus.

Outcome Measures
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Primary Outcome Measures :
  1. Long term results of the STARR operation. [ Time Frame: 10 years ]
    Dyschezia postoperatively


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient objection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05037422


Contacts
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Contact: Sandrine BARBOIS, MD 0033476765526 sandrinebarbois@yahoo.fr

Locations
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France
CHU Grenoble Alpes, Service de chirurgie digestive et de l'urgence Recruiting
Grenoble, France
Contact: Jean-Luc FAUCHERON, PU-PH    33476765371    JLFaucheron@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Jean-Luc Faucheron, MD CHU Grenoble Alpes
More Information
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Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT05037422    
Other Study ID Numbers: 38RC21.144
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: January 3, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectocele
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Hernia
Pathological Conditions, Anatomical