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

Not Applicable

• Conditions: Fecal Incontinence; Rectal Cancer; Rectal Neoplasms; Rectal Tumors
• Interventions: Procedure: Side-to-End Anastomosis; Procedure: Transverse Coloplasty

• Registration Number: NCT03074461
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-02-26
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-08
• Study Start: 2017-04-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01
• Primary Completion: 2019-09
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Side-to-End	Side-to-End Anastomosis	Side-to-End Anastomosis as neorectal reconstruction technique in low anterior resection (LAR)
Transverse Coloplasty	Transverse Coloplasty	Transverse Coloplasty pouch as neorectal reconstruction technique in low anterior resection (LAR)

Primary Outcome Measures

Name	Time	Method
Stool frequency	time = 6 months postoperative	Between group differences in stool frequency at t = 6 months postoperative

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	through study completion (an average of 12 months postoperative)	* Septic intraabdominal complications related to anastomosis (anastomotic insufficiencies, suture insufficiencies, abscesses); * Wound infection
Quality of Life	baseline, postoperative (2-3 months, 6 months, 12 months)	Quality of Life with focus on colorectally specialized questionnaires
Antimotility drug usage	baseline, postoperative (2-3 months, 6 months, 12 months)	Usage of antimotility drugs (e.g. loperamide) evaluated by standardized questionnaires

Trial Locations

Locations (3)

Maria-Theresia-Klinik; 🇩🇪 München, Bayern, Germany

Krankenhaus Barmherzige Brüder München; 🇩🇪 München, Bayern, Germany

Klinikum der Universität München; 🇩🇪 München, Bayern, Germany