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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Cancer, Rectal Neoplasms, Rectal Tumors, Fecal Incontinence

Intervention / Treatment
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* Procedure: Side-to-End Anastomosis
* Procedure: Transverse Coloplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal Cancer, Low Anterior Resection, Coloplasty Pouch, Side-to-end Anastomosis, Continence, Quality of Life