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NCT00256984 · ClinicalTrials.gov registry record · Phase 4
Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)
A Phase 4 study, sponsored by Ethicon Endo-Surgery.
- Completed
- Registry status
- Phase 4
- Development phase
- 75
- Enrollment target
NCT00256984: Completed Phase 4 study, sponsored by Ethicon Endo-Surgery.
NCT00256984 is a Phase 4 study that has completed, run by Ethicon Endo-Surgery. The registered enrollment target is 75 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00256984, a Phase 4 study, has completed, sponsored by Ethicon Endo-Surgery.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 75 participants
- Enrollment target
Study 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).
Primary Outcome
The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.
Interventions
- PROCEDURE Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2005-10-01 |
| Est. Completion | 2008-06-01 |
| Phase | Phase 4 |
What the finished NCT00256984 record still lists
NCT00256984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler is the first listed.
NCT00256984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00256984 about?
NCT00256984 is a clinical study titled "Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)". 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).
What is the current status of trial NCT00256984?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 75 participants. The study started on 2005-10-01. Estimated completion is 2008-06-01.
What interventions are being tested in trial NCT00256984?
The interventions under investigation include: Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler (PROCEDURE).
Who is sponsoring clinical trial NCT00256984?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00256984's enrollment target sits among peer trials
75 1002nd of 2000 higher than 974 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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