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NCT00556283 Clinical Trial

RCT: STARR vs Biofeedback

Rectocele Clinical Trial

— ODS II  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00556283
Other study ID # ODS-HJH-4
Secondary ID
Status Completed
Phase Phase 4
First received November 8, 2007
Last updated December 17, 2013
Start date February 2004
Est. completion date May 2007

Study information
Verified date December 2013
Source Ethicon Endo-Surgery (Europe) GmbH
Contact n/a
Is FDA regulated No
Health authority France: CNIL (Commission nationale de l'informatique et des libertés); ECItaly: Ethics CommitteeFrance: local ECUK: local EC
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 121
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• STARR
Stapled Trans-Anal Rectal Resection for the treatment of ODS
Behavioral:
• Biofeedback
electromyographic-based treatment sessions

Locations
Country Name City State
France Chirurgie Proctologique Besancon
France Clinique des Cèdres Cornebarrieu
France Groupe Hospitalier Diaconesses Croix Saint-Simon Paris
France Hopital Bagatelle Talence
France CHU Purpan Toulouse
Italy Ospedale S. Giuseppe Milan
Italy Ospedale "Franchini" di Montecchio Emilia Montecchio Emilia
Italy Ospedale Santa Maria degli Angeli Pordenone
United Kingdom Royal Liverpool University Hospital Liverpool

Sponsors (3)
Lead Sponsor Collaborator
Ethicon Endo-Surgery (Europe) GmbH Aysgarth Statistics, Physicians World GmbH

Countries where clinical trial is conducted

France,  Italy,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary ODS total score 12 months
Secondary PAC-QoL score 12 months
See also
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Completed NCT02280382 - An Intervention to Improve Prolapse Using Femmeze® (v1) N/A
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Completed NCT05894226 - Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele N/A
Completed NCT02971332 - Long Term Results of STARR With Contour Transtar N/A
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Recruiting NCT04547816 - Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse Phase 3
Active, not recruiting NCT02231099 - Effectiveness Prolift+M Versus Conventional Vaginal Prolapse Surgery N/A