Long Term Results of STARR With Contour Transtar

NCT02971332 | Completed

• 1 other identifier: STR016a
• Study Type: observational
• Target: 113
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rectal Prolapse; Rectocele; Intussusception of Rectum

Outcome Measures

Primary Outcomes (2)

• degree of constipation

  Cleveland Clinic Constipation Score

  6 months

• degree of constipation

  Cleveland Clinic Constipation Score

  5 years

Secondary Outcomes (1)

• Surgical Complications

  0-6 months

Other Outcomes (2)

• Defecatory aids

  6 months

• Defecatory aids

  5 years

Study Arms (1)

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

Interventions

Stapled Transanal Rectal Resection PROCEDURE

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

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• anal sphincter contractile deficiency
• previous rectal resection

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Related Publications (1)

• Mari FS, Pezzatini M, Gasparrini M, Antonio B. STARR with Contour Transtar for Obstructed Defecation Syndrome: Long-Term Results. World J Surg. 2017 Nov;41(11):2906-2911. doi: 10.1007/s00268-017-4084-6.

  PMID: 28600694 DERIVED

MeSH Terms

Conditions

Rectal Prolapse; Rectocele

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hernia

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FACS

Study Record Dates

• First Submitted: November 20, 2016
• First Posted: November 22, 2016
• Study Start: June 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2016
• Last Updated: November 22, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share