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RCT: STARR vs Biofeedback

NCT ID: NCT00556283

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2007-05-31

Brief Summary

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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

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Conditions

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Gastric Outlet Obstruction Rectocele Intussusception Anismus

Keywords

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outlet obstruction rectocele

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

STARR

Group Type EXPERIMENTAL

STARR

Intervention Type DEVICE

Stapled Trans-Anal Rectal Resection for the treatment of ODS

2

Biofeedback

Group Type ACTIVE_COMPARATOR

Biofeedback

Intervention Type BEHAVIORAL

electromyographic-based treatment sessions

Interventions

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STARR

Stapled Trans-Anal Rectal Resection for the treatment of ODS

Intervention Type DEVICE

Biofeedback

electromyographic-based treatment sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aysgarth Statistics

UNKNOWN

Sponsor Role collaborator

Physicians World GmbH

UNKNOWN

Sponsor Role collaborator

Ethicon Endo-Surgery (Europe) GmbH

INDUSTRY

Sponsor Role lead

Principal Investigators

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Paul A Lehur, MD

Role: PRINCIPAL_INVESTIGATOR

Institut des Maladies de l'Appareil Digestif (IMAD), University Hospital of Nantes, 1 place A Ricordeau, F-44093 Nantes Cedex 01

Goran Ribaric, MD, PhD

Role: STUDY_DIRECTOR

Ethicon Endo-Surgery (Europe) GmbH

Locations

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Chirurgie Proctologique

Besançon, , France

Site Status

Clinique des Cèdres

Cornebarrieu, , France

Site Status

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, , France

Site Status

Hopital Bagatelle

Talence, , France

Site Status

CHU Purpan

Toulouse, , France

Site Status

Ospedale S. Giuseppe

Milan, , Italy

Site Status

Ospedale "Franchini" di Montecchio Emilia

Montecchio Emilia, , Italy

Site Status

Ospedale Santa Maria degli Angeli

Pordenone, , Italy

Site Status

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Site Status

Countries

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France Italy United Kingdom

Other Identifiers

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ODS-HJH-4

Identifier Type: -

Identifier Source: org_study_id