Clinical trial NCT00556283: RCT: STARR vs Biofeedback
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Outlet Obstruction
Rectocele
Intussusception
Anismus
Keywords: outlet obstruction
rectocele
Lead sponsor: Ethicon Endo-Surgery (Europe) GmbH
Sponsor class: INDUSTRY
Collaborators: name: Aysgarth Statistics
name: Physicians World GmbH
First posted: 2007-11-09
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: ODS total score
timeFrame: 12 months
Secondary outcomes:
measure: PAC-QoL score
timeFrame: 12 months
Other outcomes:
Locations:
city: Besancon
country: France
facility: Chirurgie Proctologique
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint-Simon
city: Talence
country: France
facility: Hopital Bagatelle
city: Toulouse
country: France
facility: CHU Purpan
city: Milan
country: Italy
facility: Ospedale S. Giuseppe
city: Montecchio Emilia
country: Italy
facility: Ospedale "Franchini" di Montecchio Emilia
city: Pordenone
country: Italy
facility: Ospedale Santa Maria degli Angeli
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
Study officials:
affiliation: Institut des Maladies de l'Appareil Digestif (IMAD), University Hospital of Nantes, 1 place A Ricordeau, F-44093 Nantes Cedex 01
name: Paul A Lehur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ethicon Endo-Surgery (Europe) GmbH
name: Goran Ribaric, MD, PhD
role: STUDY_DIRECTOR
References: