bowel cancer and anastomotic leakage after surgery Colorectal cancer
Conditions
Interventions
Patients are randomly allocated for either perioperative SDD (intervention
group) or standard treatment (control group). The solution containing SDD is
orally taken 4 times daily, starting 3 days be
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Elective colon and rectal cancer surgery with primary anastomosis * No evidence of distant metastases (preoperative CT-abdomen and X-thorax or CT-thorax) * Procedure either with or without diverting stoma * Both laparoscopic and open surgery * Informed consent
Exclusion criteria
Exclusion criteria: * Inflammatory bowel disease (Crohn's disease or ulcerative colitis) * A history of colorectal malignancy * Current malignancy now undergoing treatment * Previous surgery for diverticulitis / diverticulosis * Performance status ASA 4 or higher (American Society of Anaesthesiologists) * Expected reactions / allergies to the study medication * Reversal of a temporary colostomy or ileostomy * Prednisone use of more than 5 mg per day * Familial adenomatous polyposis coli (FAP, Lynch syndrome), Hereditary Non Polyposis Colorectal Cancer (HNPCC) * Inability to give informed consent * Pregnancy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are other postoperative infectious complications (including pneumonia, urinary tract infections, surgical site infections, wound dehiscence), in-hospital mortality, readmission rate, reoperation rate, duration of hospital stay, quality of life, in-hospital and out-of-hospital costs. Moreover, disease free survival is evaluated at 3 and 5 years. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the SELECT trial is anastomotic leakage, which is defined as clinical and/or radiological evidence of anastomotic dehiscence requiring surgical or radiological (re)intervention. | — |
Countries
Netherlands
Outcome results
None listed