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RCT: STARR vs Biofeedback

NCT00556283 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2013-12-18

No results posted yet for this study

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

  • Gastric Outlet Obstruction
  • Rectocele
  • Intussusception
  • Anismus

Interventions

DEVICE

STARR

Stapled Trans-Anal Rectal Resection for the treatment of ODS

BEHAVIORAL

Biofeedback

electromyographic-based treatment sessions

Sponsors & Collaborators

  • Aysgarth Statistics

    collaborator UNKNOWN

  • Physicians World GmbH

    collaborator UNKNOWN

  • Ethicon Endo-Surgery (Europe) GmbH

    lead INDUSTRY

Principal Investigators

  • Paul A Lehur, MD · Institut des Maladies de l'Appareil Digestif (IMAD), University Hospital of Nantes, 1 place A Ricordeau, F-44093 Nantes Cedex 01

  • Goran Ribaric, MD, PhD · Ethicon Endo-Surgery (Europe) GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Completion
2007-05-31

Countries

  • France
  • Italy
  • United Kingdom

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 NCT00556283 on ClinicalTrials.gov