NCT05037422

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 16, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2024

Completed
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

April 29, 2021

Last Update Submit

January 2, 2024

Conditions

Rectocele; Female

Outcome Measures

Primary Outcomes (1)

  • Long term results of the STARR operation.

    Dyschezia postoperatively

    10 years

Interventions

STARR surgeryPROCEDURE

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patient objection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble Alpes, Service de chirurgie digestive et de l'urgence

Grenoble, France

RECRUITING

Related Publications (4)

  • Lehur PA, Stuto A, Fantoli M, Villani RD, Queralto M, Lazorthes F, Hershman M, Carriero A, Pigot F, Meurette G, Narisetty P, Villet R; ODS II Study Group. Outcomes of stapled transanal rectal resection vs. biofeedback for the treatment of outlet obstruction associated with rectal intussusception and rectocele: a multicenter, randomized, controlled trial. Dis Colon Rectum. 2008 Nov;51(11):1611-8. doi: 10.1007/s10350-008-9378-1. Epub 2008 Jul 19.

    PMID: 18642046BACKGROUND

  • Slim K, Mezoughi S, Launay-Savary MV, Tuech JJ, Michot F, Sielezneff I, Sastre B, Pigot F, Juguet F, Faucheron JL, Voirin D, Chipponi J. [Repair of rectocele using the Stapled TransAnal Rectal Resection (STARR) technique: intermediate results from a multicenter French study]. J Chir (Paris). 2008 Jan-Feb;145(1):27-31. doi: 10.1016/s0021-7697(08)70298-9. French.

    PMID: 18438279BACKGROUND

  • Gagliardi G, Pescatori M, Altomare DF, Binda GA, Bottini C, Dodi G, Filingeri V, Milito G, Rinaldi M, Romano G, Spazzafumo L, Trompetto M; Italian Society of Colo-Rectal Surgery (SICCR). Results, outcome predictors, and complications after stapled transanal rectal resection for obstructed defecation. Dis Colon Rectum. 2008 Feb;51(2):186-95; discussion 195. doi: 10.1007/s10350-007-9096-0. Epub 2007 Dec 22.

    PMID: 18157718BACKGROUND

  • Liu WC, Wan SL, Yaseen SM, Ren XH, Tian CP, Ding Z, Zheng KY, Wu YH, Jiang CQ, Qian Q. Transanal surgery for obstructed defecation syndrome: Literature review and a single-center experience. World J Gastroenterol. 2016 Sep 21;22(35):7983-98. doi: 10.3748/wjg.v22.i35.7983.

    PMID: 27672293BACKGROUND

MeSH Terms

Conditions

Rectocele

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Luc Faucheron, MD

    CHU Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandrine BARBOIS, MD

CONTACT

0033476765526sandrinebarbois@yahoo.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2021

First Posted

September 8, 2021

Study Start

October 16, 2021

Primary Completion

October 24, 2024

Study Completion

November 24, 2024

Last Updated

January 3, 2024

Record last verified: 2024-01

Locations

FR(1)