RCT: STARR vs Biofeedback

Phase 4

Completed

• Conditions: Gastric Outlet Obstruction; Anismus; Intussusception; Rectocele
• Interventions: Device: STARR; Behavioral: Biofeedback

• Registration Number: NCT00556283
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study Completion: 2007-05
• Study First Submitted: 2007-11-08
• Study First Submitted QC: 2007-11-08
• Study First Posted: 2007-11-09
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	STARR	STARR
2	Biofeedback	Biofeedback

Primary Outcome Measures

Name	Time	Method
ODS total score	12 months

Secondary Outcome Measures

Name	Time	Method
PAC-QoL score	12 months

Trial Locations

Locations (9)

Clinique des Cèdres; 🇫🇷 Cornebarrieu, France

Chirurgie Proctologique; 🇫🇷 Besancon, France

Hopital Bagatelle; 🇫🇷 Talence, France

CHU Purpan; 🇫🇷 Toulouse, France

Groupe Hospitalier Diaconesses Croix Saint-Simon; 🇫🇷 Paris, France

Ospedale S. Giuseppe; 🇮🇹 Milan, Italy

Ospedale Santa Maria degli Angeli; 🇮🇹 Pordenone, Italy

Ospedale "Franchini" di Montecchio Emilia; 🇮🇹 Montecchio Emilia, Italy

Royal Liverpool University Hospital; 🇬🇧 Liverpool, United Kingdom