Fecal Incontinence, Rectal Cancer, Rectal Neoplasms, Rectal Tumors
Conditions
Keywords
Rectal Cancer, Low Anterior Resection, Coloplasty Pouch, Side-to-end Anastomosis, Continence, Quality of Life
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.
Interventions
PROCEDURESide-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.
PROCEDURETransverse 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.
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
There is no masking in the CSAR Trial
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool frequency | time = 6 months postoperative | Between group differences in stool frequency at t = 6 months postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | through study completion (an average of 12 months postoperative) | * Septic intraabdominal complications related to anastomosis (anastomotic insufficiencies, suture insufficiencies, abscesses); * Wound infection |
| Quality of Life | baseline, postoperative (2-3 months, 6 months, 12 months) | Quality of Life with focus on colorectally specialized questionnaires |
| Antimotility drug usage | baseline, postoperative (2-3 months, 6 months, 12 months) | Usage of antimotility drugs (e.g. loperamide) evaluated by standardized questionnaires |
Countries
Germany
Contacts
Primary ContactMarkus Rentsch, MD
Backup ContactSandro M Hasenhütl, MD
Outcome results
None listed