CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 75 enrolled
Drug / intervention
Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Staplerprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00256984
NCT00256984Phase 4Completed
CompareCT.gov

A Multi-center Study to Assess the Outcomes of Stapled Trans-Anal Rectal Resection (STARR) in the Treatment of Obstructed Defecation Syndrome (ODS)

Ethicon Endo-Surgery·interventional·Posted Nov 22, 2005·Updated Jul 16, 2018

In Brief

A Phase 4 clinical trial evaluating Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler for Obstructive Defecation Syndrome and 3 related conditions. Completed, enrolled 75 participants across 7 sites.

Detailed Summary

The primary purpose of this study is to determine how effective and how durable STARR (stapled transanal rectal resection) surgery is in relieving symptoms of intractable constipation associated with obstructive defecation syndrome (ODS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Defecation Syndrome, Chronic Constipation, Rectocele, Intussusception
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 22, 2005
Enrollment StartOct 1, 2005
Primary CompletionMar 1, 2008
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.6 years ago

Interventions

Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Staplerprocedure