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

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer; Rectal Neoplasms; Fecal Incontinence; Rectal Tumors
• Intervention / Treatment: Procedure: Side-to-End Anastomosis; Procedure: Transverse Coloplasty

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • München, Bayern, Germany, 80336
      • Not yet recruiting
      • Maria-Theresia-Klinik
      • Contact: Andreas Hölscher, MD; Phone Number: 0049/89/7207325; Email: dr.hoelscher@maria-theresia-klinik.de
      • Contact: Carolin Orlitsch, MD; Phone Number: 0049/89/7207325; Email: dr.orlitsch@maria-theresia-klinik.de
    • München, Bayern, Germany, 80639
      • Not yet recruiting
      • Krankenhaus Barmherzige Brüder München
      • Contact: Johann Spatz, MD; Phone Number: 0049/89/17972302; Email: johann.spatz@barmherzige-muenchen.de
    • München, Bayern, Germany, 81377
      • Recruiting
      • Klinikum der Universität München
      • Contact: Markus Rentsch, MD; Phone Number: 0049/89/4400/711213; Email: markus.rentsch@med.uni-muenchen.de
      • Contact: Sandro M Hasenhütl, MD; Phone Number: 0049/89/4400/711242; Email: sandro.hasenhuetl@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Side-to-End; Side-to-End Anastomosis as neorectal reconstruction technique in low anterior resection (LAR)	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.
Active Comparator: Transverse Coloplasty; Transverse Coloplasty pouch as neorectal reconstruction technique in low anterior resection (LAR)	Procedure: 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.; Other Names: Coloplasty Pouch, Transverse Coloplasty Pouch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool frequency	Between group differences in stool frequency at t = 6 months postoperative	time = 6 months postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Markus Rentsch, MD, Department of General, Visceral, and Transplantation Surgery

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: February 26, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Quality of Life; Rectal Cancer; Continence; Low Anterior Resection; Coloplasty Pouch; Side-to-end Anastomosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Fecal Incontinence
• Other Study ID Numbers: 17-129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make individual participant data available to third parties beyond the study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No