RCT: STARR vs Biofeedback (ODS II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00556283
Recruitment Status : Completed
First Posted : November 9, 2007
Last Update Posted : December 18, 2013
Aysgarth Statistics
Physicians World GmbH
Information provided by:
Ethicon Endo-Surgery (Europe) GmbH

November 8, 2007
November 9, 2007
December 18, 2013
February 2004
Not Provided
ODS total score [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT00556283 on Archive Site
PAC-QoL score [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
RCT: STARR vs Biofeedback
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
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).
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Gastric Outlet Obstruction
  • Rectocele
  • Intussusception
  • Anismus
  • Device: STARR
    Stapled Trans-Anal Rectal Resection for the treatment of ODS
  • Behavioral: Biofeedback
    electromyographic-based treatment sessions
  • Experimental: 1
    Intervention: Device: STARR
  • Active Comparator: 2
    Intervention: Behavioral: Biofeedback
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2007
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

Evidence of external sphincter injury associated with incontinence.

  1. Enterocele at rest- requiring surgery.
  2. Faecal incontinence (soiling and faecal urgency is admissible).
  3. Any anterior defect, colpocele or cystocele requiring a combined surgical approach.
  4. Physical or psychological condition which would impair participation in the study.
  5. Participation in any other device or drug study within 90 days prior to enrollment.
  6. Planned participation in any other device study during the timeframe of this study.
  7. General contraindication for surgery.
  8. Previous transanal surgery for ODS.
  9. Immunocompromised subjects
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   United Kingdom
Not Provided
Not Provided
Not Provided
Ethicon Endo-Surgery (Europe) GmbH
  • Aysgarth Statistics
  • Physicians World GmbH
Principal Investigator: 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
Study Director: Goran Ribaric, MD, PhD Ethicon Endo-Surgery (Europe) GmbH
Ethicon Endo-Surgery (Europe) GmbH
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP