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Long Term Results of STARR With Contour Transtar

STARR With Contour Transtar for Obstructed Defecation Syndrome: Long Term Results

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02971332
Acronym
LTSTARR
Enrollment
113
Registered
2016-11-22
Start date
2007-06-30
Completion date
2016-01-31
Last updated
2016-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intussusception of Rectum, Rectal Prolapse, Rectocele

Brief summary

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.

Interventions

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.

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ODS * presence of a rectocele that did not empty and/or a recto-rectal or recto-anal intussusception.

Exclusion criteria

* anal sphincter contractile deficiency * previous rectal resection

Design outcomes

Primary

MeasureTime frameDescription
degree of constipation6 monthsCleveland Clinic Constipation Score

Secondary

MeasureTime frameDescription
Surgical Complications0-6 monthsintraoperative and postoperative surgical complications

Other

MeasureTime frameDescription
Defecatory aids6 monthsthe use of laxatives or digitation to defecate

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026