PRO-REST: Surgical Treatment of Obstructed Defecation Syndrome

Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)
Overall Status
Unknown status
CT.gov ID
NCT01899209
Collaborator
University of Bologna (Other)
40
1
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: STARR
  • Procedure: Laparoscopic Ventral Rectopexy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Obstructed Defecation Caused by Rectal Intussusception and Rectocele:STARR Versus Laparoscopic Ventral Rectopexy
Study Start Date :
Aug 1, 2013
Anticipated Primary Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

STARR

Procedure: STARR

Experimental: Group B

Laparoscopic ventral Rectopexy

Procedure: Laparoscopic Ventral Rectopexy

Outcome Measures

Primary Outcome Measures

  1. Functional result [12 months]

    comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery

Secondary Outcome Measures

  1. Anatomical result [12 months]

    Comparison of clinical and radiological data before and 12 months after surgery

Other Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Bologna Italy 40138

Sponsors and Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • University of Bologna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dajana Cuicchi, Dr Dajana Cuicchi, IRCCS Azienda Ospedaliero-Universitaria di Bologna
ClinicalTrials.gov Identifier:
NCT01899209
Other Study ID Numbers:
  • PRO-REST
First Posted:
Jul 15, 2013
Last Update Posted:
Jun 27, 2014
Last Verified:
Jun 1, 2014
Keywords provided by Dajana Cuicchi, Dr Dajana Cuicchi, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2014