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Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)

NCT00256984 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-07-16

Study results available
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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).

Conditions

  • Obstructive Defecation Syndrome
  • Chronic Constipation
  • Rectocele
  • Intussusception

Interventions

PROCEDURE

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

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    lead INDUSTRY

Principal Investigators

  • Robin F Scamuffa, MS · Ethicon Endo-Surgery

  • William Bernie, MD · Ethicon Endo-Surgery

  • Anthony J Senagore, MD · Medical University of Ohio

  • Anders F Mellgren, MD, PhD · University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-01
Primary Completion
2008-03-01
Completion
2008-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00256984 on ClinicalTrials.gov