RCT: STARR vs Biofeedback (ODS II)

This study has been completed.
Sponsor:
Collaborators:
Aysgarth Statistics
Physicians World GmbH
Information provided by:
Ethicon Endo-Surgery (Europe) GmbH
ClinicalTrials.gov Identifier:
NCT00556283
First received: November 8, 2007
Last updated: December 17, 2013
Last verified: December 2013

November 8, 2007
December 17, 2013
February 2004
Not Provided
ODS total score [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT00556283 on ClinicalTrials.gov 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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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
    STARR
    Intervention: Device: STARR
  • Active Comparator: 2
    Biofeedback
    Intervention: Behavioral: Biofeedback
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   United Kingdom
 
NCT00556283
ODS-HJH-4
Yes
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