ODS II: RCT: STARR vs Biofeedback

• Sponsor: Ethicon Endo-Surgery (Europe) GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00556283
• Collaborator: Aysgarth Statistics (Other), Physicians World GmbH (Other)
• Enrollment: 121
• Locations: 9
• Arms: 2
• Duration (Months): 38.9
• Patients Per Site: 13.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Feb 1, 2004
• Actual Study Completion Date: May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. ODS total score [12 months]

Secondary Outcome Measures

1. PAC-QoL score [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chirurgie Proctologique	Besancon		France	25000
2	Clinique des Cèdres	Cornebarrieu		France	31700
3	Groupe Hospitalier Diaconesses Croix Saint-Simon	Paris		France	75012
4	Hopital Bagatelle	Talence		France	33401
5	CHU Purpan	Toulouse		France	31055
6	Ospedale S. Giuseppe	Milan		Italy	20123
7	Ospedale "Franchini" di Montecchio Emilia	Montecchio Emilia		Italy	42027
8	Ospedale Santa Maria degli Angeli	Pordenone		Italy	33170
9	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00556283
• Other Study ID Numbers: ODS-HJH-4
• First Posted: Nov 9, 2007
• Last Update Posted: Dec 18, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by , ,: outlet obstruction; rectocele
• Additional relevant MeSH terms: Rectocele; Intussusception; Gastric Outlet Obstruction; Pyloric Stenosis

Study Results

No Results Posted as of Dec 18, 2013