LTSTARR: Long Term Results of STARR With Contour Transtar

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Completed

CT.gov ID

NCT02971332

Collaborator

(none)

113

Enrollment

103

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Prolapse Rectocele Intussusception of Rectum	Procedure: Stapled Transanal Rectal Resection

Study Design

Study Type:

Observational

Actual Enrollment :

113 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Treatment Group 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. Other Names: STARR

Arm

Intervention/Treatment

Treatment Group

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.

Other Names:

STARR

Outcome Measures

Primary Outcome Measures

degree of constipation [6 months]
Cleveland Clinic Constipation Score
degree of constipation [5 years]
Cleveland Clinic Constipation Score

Secondary Outcome Measures

Surgical Complications [0-6 months]
intraoperative and postoperative surgical complications

Other Outcome Measures

Defecatory aids [6 months]
the use of laxatives or digitation to defecate
Defecatory aids [5 years]
the use of laxatives or digitation to defecate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Francesco Saverio Mari, MD, PhD, FACS, MD, PhD, FACS, University of Roma La Sapienza

ClinicalTrials.gov Identifier:

NCT02971332

Other Study ID Numbers:

STR016a

First Posted:

Nov 22, 2016

Last Update Posted:

Nov 22, 2016

Last Verified:

Nov 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2016