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

NCT ID: NCT03074461

Last Updated: 2017-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-05
• Study Completion Date: 2020-03-31

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.

Conditions

Rectal Cancer; Rectal Neoplasms; Rectal Tumors; Fecal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Side-to-End

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

Group Type: EXPERIMENTAL

Side-to-End Anastomosis

Intervention Type: 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.

Transverse Coloplasty

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

Group Type: ACTIVE_COMPARATOR

Transverse Coloplasty

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Coloplasty Pouch, Transverse Coloplasty Pouch

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Markus Rentsch

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Markus Rentsch, MD

Role: PRINCIPAL_INVESTIGATOR

Department of General, Visceral, and Transplantation Surgery

Locations

Maria-Theresia-Klinik

München, Bavaria, Germany

Site Status: NOT_YET_RECRUITING

Krankenhaus Barmherzige Brüder München

München, Bavaria, Germany

Site Status: NOT_YET_RECRUITING

Klinikum der Universität München

München, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Markus Rentsch, MD

Role: CONTACT

markus.rentsch@med.uni-muenchen.de

0049/89/4400/711213

Sandro M Hasenhütl, MD

Role: CONTACT

sandro.hasenhuetl@med.uni-muenchen.de

0049/89/4400/711242

Facility Contacts

Andreas Hölscher, MD

Role: primary

dr.hoelscher@maria-theresia-klinik.de

0049/89/7207325

Carolin Orlitsch, MD

Role: backup

dr.orlitsch@maria-theresia-klinik.de

0049/89/7207325

Johann Spatz, MD

Role: primary

johann.spatz@barmherzige-muenchen.de

0049/89/17972302

Markus Rentsch, MD

Role: primary

markus.rentsch@med.uni-muenchen.de

0049/89/4400/711213

Sandro M Hasenhütl, MD

Role: backup

sandro.hasenhuetl@med.uni-muenchen.de

0049/89/4400/711242

Other Identifiers

17-129

Identifier Type: -

Identifier Source: org_study_id