RCT: STARR vs Biofeedback

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00556283

Acronym

ODS II

Enrollment

121

Registered

2007-11-09

Start date

2004-02-29

Completion date

2007-05-31

Last updated

2013-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anismus, Gastric Outlet Obstruction, Intussusception, Rectocele

Keywords

outlet obstruction, rectocele

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).

Interventions

BEHAVIORALBiofeedback

electromyographic-based treatment sessions

DEVICESTARR

Stapled Trans-Anal Rectal Resection for the treatment of ODS

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
ODS total score	12 months

Secondary

Measure	Time frame
PAC-QoL score	12 months

Countries

France, Italy, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026