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

Ludwig Maximilian University of Munich

Status: Unknown

Conditions: Rectal Tumors; Fecal Incontinence; Rectal Neoplasms; Rectal Cancer

Treatments: Procedure: Side-to-End Anastomosis; Procedure: Transverse Coloplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03074461

17-129

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Side-to-End

Experimental group

Description:

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

Treatment:

Procedure: Side-to-End Anastomosis

Transverse Coloplasty

Active Comparator group

Description:

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

Treatment:

Procedure: Transverse Coloplasty