Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial

Rectal Cancer Clinical Trial

— CSAR  

Official title:

Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03074461
• Other study ID #: 17-129
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2017
• Last updated: May 31, 2017
• Start date: April 5, 2017
• Est. completion date: March 2020

Study information

• Verified date: May 2017
• Source: Ludwig-Maximilians - University of Munich
• Contact: Markus Rentsch, MD
• Phone: 0049/89/4400/711213
• Email: markus.rentsch[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end anastomosis as rectal reservoir reconstruction offers the best functional results.

Description:

This study directly compares two neorectal reservoir-techniques, the transverse coloplasty and the side-to-end anastomosis, in low anterior resection in distal rectal cancer for the first time. Its focus is on the functional results. Besides stool frequency, the quality of life, safety of the procedures and the usage of stool modulating drugs is monitored in an 12 months-follow up regime.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled low anterior resection in patients with distal rectal carcinoma and planned anastomosis in mid/distal third of rectum

• Local curative approach

• Normal continence preoperatively

• Non-IBD-associated carcinoma

• Possible sphincter salvage

• Signed informed consent

Exclusion Criteria:

• Non-curative approaches

• Emergency surgery in cases of tumor perforation, abscess, sepsis

• Proximal rectal carcinoma (> 12 cm from anocutaneous line)

• Lack of informed consent

• Age <18 years

• Inclusion in other trials with interference of endpoints

• Life expectancy less than 24 months (as estimated by the treating physicians)

• Pregnancy

• Immunosuppression

Related Conditions & MeSH terms

• Fecal Incontinence
• Rectal Cancer
• Rectal Neoplasms
• Rectal Tumors

Intervention

Procedure:
• Side-to-End Anastomosis
During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a side-to-end colorectal anastomosis.
• Transverse Coloplasty
During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a transverse coloplasty pouch. For this purpose an end-to-end colorectal anastomosis is initially performed, followed by a longitudinal incision of approx. 8-10 cm length proximal of the anastomosis and a subsequent transverse suture in terms of the coloplasty technique.

Locations

Country	Name	City	State
Germany	Klinikum der Universität München	München	Bayern
Germany	Krankenhaus Barmherzige Brüder München	München	Bayern
Germany	Maria-Theresia-Klinik	München	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool frequency	Between group differences in stool frequency at t = 6 months postoperative	time = 6 months postoperative
Secondary	Postoperative complications	Septic intraabdominal complications related to anastomosis (anastomotic insufficiencies, suture insufficiencies, abscesses); Wound infection	through study completion (an average of 12 months postoperative)
Secondary	Quality of Life	Quality of Life with focus on colorectally specialized questionnaires	baseline, postoperative (2-3 months, 6 months, 12 months)
Secondary	Antimotility drug usage	Usage of antimotility drugs (e.g. loperamide) evaluated by standardized questionnaires	baseline, postoperative (2-3 months, 6 months, 12 months)