Surgical Treatment of Obstructed Defecation Syndrome

Obstructed Defecation Caused by Rectal Intussusception and Rectocele:STARR Versus Laparoscopic Ventral Rectopexy

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01899209

Acronym

PRO-REST

Enrollment

Registered

2013-07-15

Start date

2013-08-31

Completion date

Unknown

Last updated

2014-06-27

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

Conditions

Rectal Prolapse, Rectocele, Sensation of Inadequate Defecation

Keywords

Obstructed Defecation, Rectal rectocele, Intussusception, STARR, Ventral Rectopexy

Brief summary

Obstructed Defecation is a profoundly disabling condition. Many different surgical procedures has been introduced to treat patients affected by this disease. The most used are STARR and ventral rectopexy. Because of the heterogenity of studies and overall the lack of comparison trials, there is no accepted standard surgical treatment.PRO-REST aimed to compare these two procedures (STARR and Ventral Rectopexy) evaluating functional and anatomical results.

Interventions

PROCEDURESTARR

PROCEDURELaparoscopic Ventral Rectopexy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients affected by Obstructed Defecation with ODS score \>11 * Symptomatic rectal Intussusception and/or defecographic finding of rectocele\>2 cm * Failure of at least 6 months of medical therapy * Exclusion of neoplasm by rectosigmoidoscopy/colonoscopy

Exclusion criteria

* Patients affected by complete rectal prolapse * Patients affected by slow transit constipation * Patients affected by anismus * Patients affected by pelvic organ prolapse * Patients with previous rectal or anal surgery

Design outcomes

Primary

Measure	Time frame	Description
Functional result	12 months	comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery

Secondary

Measure	Time frame	Description
Anatomical result	12 months	Comparison of clinical and radiological data before and 12 months after surgery

Other

Measure	Time frame	Description
Quality of life and safety	12 months	Comparison of Constipation-Related Quality of Life questionnaire (CRQoL) before and 12 months after surgery Comparison of morbidity and mortality rate between the two procedures

Countries

Italy

Contacts

Primary ContactDajana Cuicchi, MD PhD

dajana.cuicchi@aosp.bo.it0516363236

Outcome results

None listed

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