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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

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).

Condition or disease Intervention/treatment Phase
Gastric Outlet Obstruction Rectocele Intussusception Anismus Device: STARR Behavioral: Biofeedback Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2004
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Device: STARR
Stapled Trans-Anal Rectal Resection for the treatment of ODS

Active Comparator: 2
Behavioral: Biofeedback
electromyographic-based treatment sessions

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00556283

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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
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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

Layout table for additonal information Identifier: NCT00556283     History of Changes
Other Study ID Numbers: ODS-HJH-4
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2013

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

Additional relevant MeSH terms:
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Gastric Outlet Obstruction
Pyloric Stenosis
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Intestinal Obstruction
Stomach Diseases