STARR: Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ? (Compli-STARR)
Trial Overview
| Acronym | STARR |
|---|---|
| Number | NCT02052063 |
| Protocol Link | https://clinicaltrials.gov/ct2/show/NCT02052063 |
| Public Trial Registry Link | https://clinicaltrials.gov/ct2/show/NCT02052063 |
| Status | Open/recruiting |
| Category | Functional |
| Treatment Course | Surgery |
Trial Description
| The stapled transanal rectal resection (STARR) has recently been recommended for patients with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall intussusception. The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for endorectal resection of the distal rectum. This technique significantly improves constipation. |
Chief Investigator
|
Valérie Bridoux MD |
| Profile Link |
Lead Centre
|
University Hospital, Rouen 37 Boulevard Gambetta Rouen 76000 France |
| Website |
Collaboration and Funding
Collaborative Sites
| 1. St. Louis Missouri 63110 United States |
Funding Sponsors
| 1. University Hospital, Rouen |
Additional Information
Full Research Summary| Objective: | . |
| Aim: | The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for endorectal resection of the distal rectum. This technique significantly improves constipation. However, there are several reports of new-onset faecal incontinence after STARR and urgency has been identified as the major side-effect of this procedure. |
| Methods: | Twenty-eight patients will be enrolled in this study over a period of 36 months. Preoperative assessment will include - clinical examination - the Wexner Incontinence Score and the Faecal Incontinence Quality-of-Life Index (FIQL) to rate anal incontinence - video defecography, anorectal manometry, anal ultrasound (AUS) and measure of anal sphincter distensibility using endoFLIP Follow-up evaluation will scheduled for 3 months after surgery, and will include symptom evaluation (using the same standard questionnaires for incontinence), clinical examination and investigation using anal ultrasound and endoFLIP. |
| Reason for International Trial: | . |