Trial record 1 of 7 for:    Open Studies | rectocele
Previous Study | Return to List | Next Study

Surgical Treatment of Obstructed Defecation Syndrome (PRO-REST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Sponsor:
Collaborator:
University of Bologna
Information provided by (Responsible Party):
Dajana Cuicchi, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT01899209
First received: July 8, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Obstructed Defecation Caused by Rectal Intussusception and Rectocele:STARR Versus Laparoscopic Ventral Rectopexy

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

Primary Outcome Measures:
  • Functional result [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery


Secondary Outcome Measures:
  • Anatomical result [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Comparison of clinical and radiological data before and 12 months after surgery


Other Outcome Measures:
  • Quality of life and safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 40
Study Start Date: August 2013
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
STARR
Procedure: STARR
Experimental: Group B
Laparoscopic ventral Rectopexy
Procedure: Laparoscopic Ventral Rectopexy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 8, 2013
Last Updated: June 26, 2014
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 20, 2014