Surgical Treatment of Obstructed Defecation Syndrome (PRO-REST)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Unknown

Conditions: Rectal Prolapse; Sensation of Inadequate Defecation; Rectocele

Treatments: Procedure: STARR; Procedure: Laparoscopic Ventral Rectopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT01899209

PRO-REST

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group A

Experimental group

Description:

STARR

Treatment:

Procedure: STARR

Group B

Experimental group

Description:

Laparoscopic ventral Rectopexy

Treatment:

Procedure: Laparoscopic Ventral Rectopexy