NCT00556283

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2004

Typical duration for phase_4

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

First QC Date

November 8, 2007

Last Update Submit

December 17, 2013

Conditions

Gastric Outlet ObstructionRectoceleIntussusceptionAnismus

Keywords

outlet obstructionrectocele

Outcome Measures

Primary Outcomes (1)

  • ODS total score

    12 months

Secondary Outcomes (1)

  • PAC-QoL score

    12 months

Study Arms (2)

1

EXPERIMENTAL

STARR

Device: STARR

2

ACTIVE COMPARATOR

Biofeedback

Behavioral: Biofeedback

Interventions

STARRDEVICE

Stapled Trans-Anal Rectal Resection for the treatment of ODS

1
BiofeedbackBEHAVIORAL

electromyographic-based treatment sessions

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Chirurgie Proctologique

Besançon, 25000, France

Location

Clinique des Cèdres

Cornebarrieu, 31700, France

Location

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, 75012, France

Location

Hopital Bagatelle

Talence, 33401, France

Location

CHU Purpan

Toulouse, 31055, France

Location

Ospedale S. Giuseppe

Milan, 20123, Italy

Location

Ospedale "Franchini" di Montecchio Emilia

Montecchio Emilia, 42027, Italy

Location

Ospedale Santa Maria degli Angeli

Pordenone, 33170, Italy

Location

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

MeSH Terms

Conditions

Gastric Outlet ObstructionRectoceleIntussusception

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesRectal DiseasesIntestinal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsIntestinal Obstruction

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Goran Ribaric, MD, PhD

    Ethicon Endo-Surgery (Europe) GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 9, 2007

Study Start

February 1, 2004

Study Completion

May 1, 2007

Last Updated

December 18, 2013

Record last verified: 2013-12

Locations

FR(5)IT(3)GB(1)