An observational study in Rectal Prolapse, Rectocele and Intussusception of Rectum, sponsored by University of Roma La Sapienza. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-22.
Sponsored by University of Roma La Sapienza · Observational
Obstructed defecation syndrome (ODS) is a widespread and disabling syndrome. With this study the investigators want to evaluate the long term results of Stapled Transanal Rectal Resection (STARR) performed with Contour Transtar device in the treatment of ODS. A re-evaluation of 113 patients subjected to STARR from June 2007 to January 2010 was conducted.
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's enrollment of 113 is below the median of 200 across 21 observational studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
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patients with symptomatic ODS after failure of medical and dietary therapy and with the presence determined through cinedefecography of a rectocele that did not empty and/or a recto-rectal or recto-anal intussusception, in the absence of anal sphincter contractile deficiency
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Exclusion Criteria:
Patients candidated to STARR after the failure of medical and dietary therapy and after a complete radiological and functional study.
Procedure: Stapled Transanal Rectal Resection
The prolapsed tissue is pulled out through the CAD using e gauze pad and Allis forceps; this allows us to identify the extent of the prolapse to be resected. Four to five parachute stitches are then apposed circumferentially, like parachute cords, at the apex of the prolapse, in order to control the tissue during resection. The prolapse is then opened longitudinally at 3 o'clock with the electric scalpel between two Kocher clamps. Two traction stitches are applied at the deep vertex of the prolapse, one for each Kocher apex. The longitudinal opening then allows the surgeon to begin circumferential resection of the rectum by pulling on the parachute stitches. This maneuver is performed counterclockwise using an average of 4-6 recharges, with care to always place the stapler at the base of the prolapse. The resected specimen was always inspected before the end of the procedure.
Also known as: STARR
degree of constipation
Cleveland Clinic Constipation Score
Time frame: 6 months
degree of constipation
Cleveland Clinic Constipation Score
Time frame: 5 years
Surgical Complications
intraoperative and postoperative surgical complications
Time frame: 0-6 months
Defecatory aids
the use of laxatives or digitation to defecate
Time frame: 6 months
Defecatory aids
the use of laxatives or digitation to defecate
Time frame: 5 years
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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