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

Rectocele; Female Clinical Trial

— STARRLOC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05037422
• Other study ID #: 38RC21.144
• Status: Recruiting
• Start date: October 16, 2021
• Est. completion date: November 24, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Grenoble
• Contact: Sandrine BARBOIS, MD
• Phone: 0033476765526
• Email: sandrinebarbois[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77
• Est. completion date: November 24, 2024
• Est. primary completion date: October 24, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient operated for rectocele for 10 or more

• Age 18 and over

• Informed patients

Exclusion Criteria:

• Patient objection

Related Conditions & MeSH terms

• Rectocele
• Rectocele; Female

Intervention

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.

Locations

Country	Name	City	State
France	CHU Grenoble Alpes, Service de chirurgie digestive et de l'urgence	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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]. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term results of the STARR operation.	Dyschezia postoperatively	10 years