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RecruitingNCT05037422STARRLOCUpdated Jan 3, 2024

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

An observational study in Rectocele; Female, sponsored by University Hospital, Grenoble. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by University Hospital, Grenoble · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Oct 2021; still recruiting 5 years later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
77
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Rectocele; Female

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In context

Rectocele

50 studies on the registry are indexed under Rectocele; 9 are open to participants now.

This study's planned enrollment of 77 is below the median of 113 across 13 observational studies indexed under Rectocele.

Browse Rectocele studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient objection
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Study design

Observational model
Other
Time perspective
Other
Enrollment
77 participants (estimated)
Patient registry
No

Interventions

  • ProcedureSTARR 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.

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What researchers measure

Primary outcomes

  1. Long term results of the STARR operation.

    Dyschezia postoperatively

    Time frame: 10 years

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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]. PubMed 18642046 ↗
  • 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. PubMed 18438279 ↗
  • 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. PubMed 18157718 ↗
  • 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. PubMed 27672293 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05037422
Responsible party
Sponsor
First posted
Sep 8, 2021
Start date
Oct 16, 2021
Primary completion
Oct 24, 2024 (estimated)
Completion
Nov 24, 2024 (estimated)
Last update
Jan 3, 2024

Study contacts

Sandrine BARBOIS, MD
Contact
sandrinebarbois@yahoo.fr
0033476765526
Jean-Luc Faucheron, MD
principal investigator · CHU Grenoble Alpes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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