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
  Purpose

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
Rectocele
Intussusception
Anismus
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
STARR
Device: STARR
Stapled Trans-Anal Rectal Resection for the treatment of ODS
Active Comparator: 2
Biofeedback
Behavioral: Biofeedback
electromyographic-based treatment sessions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556283

Locations
France
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
Italy
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
Investigators
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

No publications provided

ClinicalTrials.gov Identifier: NCT00556283     History of Changes
Other Study ID Numbers: ODS-HJH-4
Study First Received: November 8, 2007
Last Updated: December 17, 2013
Health Authority: France: CNIL (Commission nationale de l'informatique et des libertés); EC
Italy: Ethics Committee
France: local EC
UK: local EC

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

Additional relevant MeSH terms:
Intussusception
Gastric Outlet Obstruction
Pyloric Stenosis
Rectocele
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 22, 2014