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Surgical Treatment of Obstructed Defecation Syndrome (PRO-REST)

Primary Purpose

Sensation of Inadequate Defecation, Rectal Prolapse, Rectocele

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
STARR
Laparoscopic Ventral Rectopexy
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensation of Inadequate Defecation focused on measuring Obstructed Defecation, Rectal rectocele, Intussusception, STARR, Ventral Rectopexy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

STARR

Laparoscopic ventral Rectopexy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 8, 2013
Last Updated
June 26, 2014
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT01899209
Brief Title
Surgical Treatment of Obstructed Defecation Syndrome
Acronym
PRO-REST
Official Title
Obstructed Defecation Caused by Rectal Intussusception and Rectocele:STARR Versus Laparoscopic Ventral Rectopexy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
University of Bologna

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensation of Inadequate Defecation, Rectal Prolapse, Rectocele
Keywords
Obstructed Defecation, Rectal rectocele, Intussusception, STARR, Ventral Rectopexy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
STARR
Arm Title
Group B
Arm Type
Experimental
Arm Description
Laparoscopic ventral Rectopexy
Intervention Type
Procedure
Intervention Name(s)
STARR
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Ventral Rectopexy
Primary Outcome Measure Information:
Title
Functional result
Description
comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Anatomical result
Description
Comparison of clinical and radiological data before and 12 months after surgery
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Quality of life and safety
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dajana Cuicchi, MD PhD
Phone
0516363236
Ext
0039
Email
dajana.cuicchi@aosp.bo.it
Facility Information:
Facility Name
University Hospital
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dajana Cuicchi, MD PhD
Phone
0516363236
Ext
0039
Email
cuicchidajana@yahoo.it
First Name & Middle Initial & Last Name & Degree
Dajana Cuicchi, MD PhD

12. IPD Sharing Statement

Learn more about this trial

Surgical Treatment of Obstructed Defecation Syndrome

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