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

NCT03074461 | Unknown

• 1 other identifier: 17-129
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Rectal Cancer; Rectal Neoplasms; Rectal Tumors; Fecal Incontinence

Keywords

Rectal Cancer; Low Anterior Resection; Coloplasty Pouch; Side-to-end Anastomosis; Continence; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Stool frequency

  Between group differences in stool frequency at t = 6 months postoperative

  time = 6 months postoperative

Secondary Outcomes (3)

• Postoperative complications

  through study completion (an average of 12 months postoperative)

• Quality of Life

  baseline, postoperative (2-3 months, 6 months, 12 months)

• Antimotility drug usage

  baseline, postoperative (2-3 months, 6 months, 12 months)

Study Arms (2)

Side-to-End

EXPERIMENTAL

Side-to-End Anastomosis as neorectal reconstruction technique in low anterior resection (LAR)

Procedure: Side-to-End Anastomosis

Transverse Coloplasty

ACTIVE COMPARATOR

Transverse Coloplasty pouch as neorectal reconstruction technique in low anterior resection (LAR)

Procedure: Transverse Coloplasty

Interventions

Side-to-End Anastomosis PROCEDURE

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.

Side-to-End

Transverse Coloplasty PROCEDURE

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.

Also known as: Coloplasty Pouch, Transverse Coloplasty Pouch

Transverse Coloplasty

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (3)

Maria-Theresia-Klinik

München, Bavaria, 80336, Germany

NOT YET RECRUITING

Krankenhaus Barmherzige Brüder München

München, Bavaria, 80639, Germany

NOT YET RECRUITING

Klinikum der Universität München

München, Bavaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Fecal Incontinence

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Markus Rentsch, MD

  Department of General, Visceral, and Transplantation Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus Rentsch, MD

CONTACT

0049/89/4400/711213; markus.rentsch@med.uni-muenchen.de

Sandro M Hasenhütl, MD

CONTACT

0049/89/4400/711242; sandro.hasenhuetl@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking in the CSAR Trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study participants will be randomized in two parallel study arms regarding their neorectal reconstruction in low anterior resection, the experimental arm using the side-to-end anastomosis and the control group using the transverse coloplasty technique.

Study Record Dates

• First Submitted: February 26, 2017
• First Posted: March 8, 2017
• Study Start: April 5, 2017
• Primary Completion: September 1, 2019
• Study Completion: March 1, 2020
• Last Updated: June 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)