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RCT: STARR vs Biofeedback (ODS II)

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

Condition Intervention Phase
Gastric Outlet Obstruction
Device: STARR
Behavioral: Biofeedback
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Ethicon Endo-Surgery (Europe) GmbH:

Primary Outcome Measures:
  • ODS total score [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • PAC-QoL score [ Time Frame: 12 months ]

Enrollment: 121
Study Start Date: February 2004
Study Completion Date: May 2007
Arms Assigned Interventions
Experimental: 1
Device: STARR
Stapled Trans-Anal Rectal Resection for the treatment of ODS
Active Comparator: 2
Behavioral: Biofeedback
electromyographic-based treatment sessions


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00556283

Chirurgie Proctologique
Besancon, France, 25000
Clinique des Cèdres
Cornebarrieu, France, 31700
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, France, 75012
Hopital Bagatelle
Talence, France, 33401
CHU Purpan
Toulouse, France, 31055
Ospedale S. Giuseppe
Milan, Italy, 20123
Ospedale "Franchini" di Montecchio Emilia
Montecchio Emilia, Italy, 42027
Ospedale Santa Maria degli Angeli
Pordenone, Italy, 33170
United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
Sponsors and Collaborators
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
  More Information Identifier: NCT00556283     History of Changes
Other Study ID Numbers: ODS-HJH-4
Study First Received: November 8, 2007
Last Updated: December 17, 2013

Keywords provided by Ethicon Endo-Surgery (Europe) GmbH:
outlet obstruction

Additional relevant MeSH terms:
Gastric Outlet Obstruction
Pyloric Stenosis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Obstruction processed this record on April 25, 2017