Clinical trial NCT03074461: Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial
Official title: Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stool frequency
timeFrame: time = 6 months postoperative
Secondary outcomes:
measure: Postoperative complications
timeFrame: through study completion (an average of 12 months postoperative)
measure: Quality of Life
timeFrame: baseline, postoperative (2-3 months, 6 months, 12 months)
measure: Antimotility drug usage
timeFrame: baseline, postoperative (2-3 months, 6 months, 12 months)
Other outcomes:
Locations:
city: München
country: Germany
facility: Maria-Theresia-Klinik
state: Bayern
city: München
country: Germany
facility: Krankenhaus Barmherzige Brüder München
state: Bayern
city: München
country: Germany
facility: Klinikum der Universität München
state: Bayern
Study officials:
affiliation: Department of General, Visceral, and Transplantation Surgery
name: Markus Rentsch, MD
role: PRINCIPAL_INVESTIGATOR
References: