Trials / Completed
CompletedNCT00556283
RCT: STARR vs Biofeedback
Outcomes of Stapled Trans-Anal Rectal Resection (STARR) vs. Biofeedback in the Treatment of Outlet Obstruction Associated With Rectal Intussusception and Rectocele: A Multi-center Randomized Controlled Trial
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Ethicon Endo-Surgery (Europe) GmbH · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aimed to evaluate the safety and symptomatic outcomes achieved with Stapled Transanal Rectal Resection (STARR) compared to biofeedback training in patients with obstructed defecation syndrome (ODS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | STARR | Stapled Trans-Anal Rectal Resection for the treatment of ODS |
| BEHAVIORAL | Biofeedback | electromyographic-based treatment sessions |
Timeline
- Start date
- 2004-02-01
- Completion
- 2007-05-01
- First posted
- 2007-11-09
- Last updated
- 2013-12-18
Locations
9 sites across 3 countries: France, Italy, United Kingdom
Source: ClinicalTrials.gov record NCT00556283. Inclusion in this directory is not an endorsement.