Surgical Treatment of Obstructed Defecation Syndrome (PRO-REST)

June 26, 2014 updated by: Dajana Cuicchi, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • University Hospital
        • Contact:
        • Sub-Investigator:
          • Dajana Cuicchi, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
STARR
Procedure: STARR
Experimental: Group B
Laparoscopic ventral Rectopexy
Procedure: Laparoscopic Ventral Rectopexy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life and safety
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborators

University of Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 26, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-REST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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