STARRLOC: Long-term Results of the Stapled Transanal Rectal Resection (STARR) Operation Proposed in the Treatment of a Rectocele
Sponsor
University Hospital, Grenoble (Other)
Overall Status
Recruiting
CT.gov ID
NCT05037422
Collaborator
(none)
77
1
13
5.9
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated 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
:
Oct 16, 2021
Anticipated Primary Completion Date
:
Oct 16, 2022
Anticipated Study Completion Date
:
Nov 16, 2022
Outcome Measures
Primary Outcome Measures
- Long term results of the STARR operation. [10 years]
Dyschezia postoperatively
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Inclusion Criteria:
-
Patient operated for rectocele for 10 or more
-
Age 18 and over
-
Informed patients
Exclusion Criteria:
- Patient objection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Grenoble Alpes, Service de chirurgie digestive et de l'urgence | Grenoble | France |
Sponsors and Collaborators
- University Hospital, Grenoble
Investigators
- Principal Investigator: Jean-Luc Faucheron, MD, CHU Grenoble Alpes
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Epub 2007 Dec 22.
- 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. Erratum in: Dis Colon Rectum. 2008 Nov;51(11):1739. Narisetty, Prashanty [corrected to Narisetty, Prashanthi].
- 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. Review.
- 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. French.
Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT05037422
Other Study ID Numbers:
- 38RC21.144
First Posted:
Sep 8, 2021
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: