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RCT: STARR vs Biofeedback (ODS II)

Primary Purpose

Gastric Outlet Obstruction, Rectocele, Intussusception

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
STARR
Biofeedback
Sponsored by
Ethicon Endo-Surgery (Europe) GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Outlet Obstruction focused on measuring outlet obstruction, rectocele

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chirurgie Proctologique
  • Clinique des Cèdres
  • Groupe Hospitalier Diaconesses Croix Saint-Simon
  • Hopital Bagatelle
  • CHU Purpan
  • Ospedale S. Giuseppe
  • Ospedale "Franchini" di Montecchio Emilia
  • Ospedale Santa Maria degli Angeli
  • Royal Liverpool University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

STARR

Biofeedback

Outcomes

Primary Outcome Measures

ODS total score

Secondary Outcome Measures

PAC-QoL score

Full Information

First Posted
November 8, 2007
Last Updated
December 17, 2013
Sponsor
Ethicon Endo-Surgery (Europe) GmbH
Collaborators
Aysgarth Statistics, Physicians World GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00556283
Brief Title
RCT: STARR vs Biofeedback
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ethicon Endo-Surgery (Europe) GmbH
Collaborators
Aysgarth Statistics, Physicians World GmbH

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Outlet Obstruction, Rectocele, Intussusception, Anismus
Keywords
outlet obstruction, rectocele

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
STARR
Arm Title
2
Arm Type
Active Comparator
Arm Description
Biofeedback
Intervention Type
Device
Intervention Name(s)
STARR
Intervention Description
Stapled Trans-Anal Rectal Resection for the treatment of ODS
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Intervention Description
electromyographic-based treatment sessions
Primary Outcome Measure Information:
Title
ODS total score
Time Frame
12 months
Secondary Outcome Measure Information:
Title
PAC-QoL score
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients >18 years old Able to comprehend, follow, and provide written informed consent. Minimum ODS Score of seven at screening. Negative pregnancy test, by urine. 'Obstructed' defecation requiring straining/digitation as presenting lead symptom. Adequate external sphincter on rectal digital examination. Evidence of anterior rectocele and/or rectal intussusception on dynamic defecography. (Note: dynamic defecography taken within 12 months will be acceptable) Willingness to comply with study requirements including follow-up visits Exclusion Criteria: Evidence of external sphincter injury associated with incontinence. Enterocele at rest- requiring surgery. Faecal incontinence (soiling and faecal urgency is admissible). Any anterior defect, colpocele or cystocele requiring a combined surgical approach. Physical or psychological condition which would impair participation in the study. Participation in any other device or drug study within 90 days prior to enrollment. Planned participation in any other device study during the timeframe of this study. General contraindication for surgery. Previous transanal surgery for ODS. Immunocompromised subjects
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Lehur, MD
Organizational Affiliation
Institut des Maladies de l'Appareil Digestif (IMAD), University Hospital of Nantes, 1 place A Ricordeau, F-44093 Nantes Cedex 01
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Goran Ribaric, MD, PhD
Organizational Affiliation
Ethicon Endo-Surgery (Europe) GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Chirurgie Proctologique
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Clinique des Cèdres
City
Cornebarrieu
ZIP/Postal Code
31700
Country
France
Facility Name
Groupe Hospitalier Diaconesses Croix Saint-Simon
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Bagatelle
City
Talence
ZIP/Postal Code
33401
Country
France
Facility Name
CHU Purpan
City
Toulouse
ZIP/Postal Code
31055
Country
France
Facility Name
Ospedale S. Giuseppe
City
Milan
ZIP/Postal Code
20123
Country
Italy
Facility Name
Ospedale "Franchini" di Montecchio Emilia
City
Montecchio Emilia
ZIP/Postal Code
42027
Country
Italy
Facility Name
Ospedale Santa Maria degli Angeli
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom

12. IPD Sharing Statement

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RCT: STARR vs Biofeedback

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