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Surgical Treatment of Obstructed Defecation Syndrome (PRO-REST)

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ClinicalTrials.gov Identifier: NCT01899209
Recruitment Status : Unknown
Verified June 2014 by Dajana Cuicchi, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
Recruitment status was:  Recruiting
First Posted : July 15, 2013
Last Update Posted : June 27, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Sensation of Inadequate Defecation Rectal Prolapse Rectocele Procedure: STARR Procedure: Laparoscopic Ventral Rectopexy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2013
Estimated Primary Completion Date : August 2015

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U.S. FDA Resources

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 [ Time Frame: 12 months ]
    comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery


Secondary Outcome Measures :
  1. Anatomical result [ Time Frame: 12 months ]
    Comparison of clinical and radiological data before and 12 months after surgery


Other Outcome Measures:
  1. 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899209


Contacts
Contact: Dajana Cuicchi, MD PhD 0516363236 ext 0039 dajana.cuicchi@aosp.bo.it

Locations
Italy
University Hospital Recruiting
Bologna, Italy, 40138
Contact: Dajana Cuicchi, MD PhD    0516363236 ext 0039    cuicchidajana@yahoo.it   
Sub-Investigator: Dajana Cuicchi, MD PhD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
University of Bologna
More Information

Responsible Party: Dajana Cuicchi, Dr Dajana Cuicchi, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT01899209     History of Changes
Other Study ID Numbers: PRO-REST
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: June 27, 2014
Last Verified: June 2014

Keywords provided by Dajana Cuicchi, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Obstructed Defecation
Rectal rectocele
Intussusception
STARR
Ventral Rectopexy

Additional relevant MeSH terms:
Prolapse
Rectal Prolapse
Rectocele
Intussusception
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse
Hernia
Intestinal Obstruction