Surgical Treatment of Obstructed Defecation Syndrome

Rectal Prolapse Clinical Trial

— PRO-REST  

Official title:

Obstructed Defecation Caused by Rectal Intussusception and Rectocele:STARR Versus Laparoscopic Ventral Rectopexy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01899209
• Other study ID #: PRO-REST
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2013
• Last updated: June 26, 2014
• Start date: August 2013

Study information

• Verified date: June 2014
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Dajana Cuicchi, MD PhD
• Phone: 0516363236
• Email: dajana.cuicchi[@]aosp.bo.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Prolapse
• Rectocele
• Sensation of Inadequate Defecation

Intervention

Procedure:
• STARR

• Laparoscopic Ventral Rectopexy

Locations

Country	Name	City	State
Italy	University Hospital	Bologna

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi	University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life and safety	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	12 months	Yes
Primary	Functional result	comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery	12 months	Yes
Secondary	Anatomical result	Comparison of clinical and radiological data before and 12 months after surgery	12 months	Yes