Long Term Results of STARR With Contour Transtar

Rectal Prolapse Clinical Trial

— LTSTARR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971332
• Other study ID #: STR016a
• Status: Completed
• Phase: N/A
• First received: November 20, 2016
• Last updated: November 21, 2016
• Start date: June 2007
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: January 2016
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intussusception
• Intussusception of Rectum
• Prolapse
• Rectal Prolapse
• Rectocele

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Defecatory aids	the use of laxatives or digitation to defecate	6 months	No
Other	Defecatory aids	the use of laxatives or digitation to defecate	5 years	No
Primary	degree of constipation	Cleveland Clinic Constipation Score	6 months	No
Primary	degree of constipation	Cleveland Clinic Constipation Score	5 years	No
Secondary	Surgical Complications	intraoperative and postoperative surgical complications	0-6 months	Yes