Surgical Treatment of Obstructed Defecation Syndrome

NCT ID: NCT01899209

Last Updated: 2014-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sensation of Inadequate Defecation Rectal Prolapse Rectocele

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

STARR

Group Type EXPERIMENTAL

STARR

Intervention Type PROCEDURE

Group B

Laparoscopic ventral Rectopexy

Group Type EXPERIMENTAL

Laparoscopic Ventral Rectopexy

Intervention Type PROCEDURE

Interventions

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STARR

Intervention Type PROCEDURE

Laparoscopic Ventral Rectopexy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bologna

OTHER

Sponsor Role collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Dajana Cuicchi

Dr Dajana Cuicchi

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital

Bologna, Bologna, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Dajana Cuicchi, MD PhD

Role: CONTACT

0516363236 ext. 0039

Facility Contacts

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Dajana Cuicchi, MD PhD

Role: primary

0516363236 ext. 0039

Other Identifiers

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PRO-REST

Identifier Type: -

Identifier Source: org_study_id

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