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Clinical Trials/NCT00556283
NCT00556283
Completed
Phase 4

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

Ethicon Endo-Surgery (Europe) GmbH9 sites in 3 countries121 target enrollmentFebruary 2004
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ConditionsGastric Outlet ObstructionRectoceleIntussusceptionAnismus

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Gastric Outlet Obstruction
Sponsor
Ethicon Endo-Surgery (Europe) GmbH
Enrollment
121
Locations
9
Primary Endpoint
ODS total score
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
February 2004
End Date
May 2007
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Female patients \>18 years old
  • •Able to comprehend, follow, and provide written informed consent.
  • •Minimum ODS Score of seven at screening.
  • •Negative pregnancy test, by urine.
  • •'Obstructed' defecation requiring straining/digitation as presenting lead symptom.
  • •Adequate external sphincter on rectal digital examination.
  • •Evidence of anterior rectocele and/or rectal intussusception on dynamic defecography. (Note: dynamic defecography taken within 12 months will be acceptable)
  • •Willingness to comply with study requirements including follow-up visits

Exclusion Criteria

  • •Evidence of external sphincter injury associated with incontinence.
  • •Enterocele at rest- requiring surgery.
  • •Faecal incontinence (soiling and faecal urgency is admissible).
  • •Any anterior defect, colpocele or cystocele requiring a combined surgical approach.
  • •Physical or psychological condition which would impair participation in the study.
  • •Participation in any other device or drug study within 90 days prior to enrollment.
  • •Planned participation in any other device study during the timeframe of this study.
  • •General contraindication for surgery.
  • •Previous transanal surgery for ODS.
  • •Immunocompromised subjects

Outcomes

Primary Outcomes

ODS total score

Time Frame: 12 months

Secondary Outcomes

  • PAC-QoL score(12 months)

Study Sites (9)

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