Skip to main content
OpenTrials
Completed

NCT Number: NCT00556283

RCT: STARR vs Biofeedback

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Outlet Obstruction Anismus Digestive System Diseases Gastrointestinal Diseases Hernia Intestinal Diseases Intestinal Obstruction Intussusception Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectocele Stomach Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Chirurgie Proctologique, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STARR

Device

Stapled Trans-Anal Rectal Resection for the treatment of ODS

Biofeedback

Behavioral

electromyographic-based treatment sessions

Primary outcomes

  1. ODS total score

    Time frame: 12 months

Secondary outcomes

  1. PAC-QoL score

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery (Europe) GmbH

Industry

Collaborators

  • Aysgarth Statistics
  • Physicians World GmbH

Registry information

Official study title

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

Acronym: ODS II

Important dates

Study start
2004
Study completion
2007
First posted
Nov 9, 2007
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.