An interventional study of STARR and Laparoscopic Ventral Rectopexy in Sensation of Inadequate Defecation, Rectal Prolapse and Rectocele, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-27.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Not applicable, Interventional, and Treatment
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.
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's planned enrollment of 40 is below the median of 55 across 34 interventional studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
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Exclusion Criteria:
STARR
Procedure: STARR
Laparoscopic ventral Rectopexy
Procedure: Laparoscopic Ventral Rectopexy
Functional result
comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery
Time frame: 12 months
Anatomical result
Comparison of clinical and radiological data before and 12 months after surgery
Time frame: 12 months
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
Time frame: 12 months
The record gives a start of Aug 2013 and a primary completion of Aug 2015. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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