bowel cancer Colorectal cancer
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female age >= 18 years old. 2. Biopsy proven cancer of the sigmoid colon or proximal rectum (cT1-4aN0-2M0) that require AR as the procedure of choice. 3. premalignant lesions not amenable to endoscopic resection, that require AR as the procedure of choice. 4. Suitable for curative AR 5. Suitable for elective laparoscopic or robotic surgery 6. Cognitive ability to take part in the study, to understand the information the patient receives about participating in the study, to provide informed consent and to agree to complete the questionnaires.
Exclusion criteria
Exclusion criteria: 1. Pre-existing health conditions requiring emergency surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia. 2. Cancer with distant metastases (TNM Stage IV). 3. Intestinal or anal stenosis or other obstructions distal to the planned anastomosis. 4. Prior pelvic radiation including neoadjuvant chemoradiotherapy. 5. Contraindications to general anaesthesia. 6. Need for defunctioning ileostomy (intention to treat). 7. Patients who have a contra-indication for or are unable to receive preoperative bowel preparation or at least two enemas prior to surgery. 8. Immunocompromised patients e.g. taking steroids or receiving immunotherapy. 9. Any condition that, in the opinion of the investigator, may interfere with the study conduction. In particular, any condition which can cause significant alteration of colonic wall thickness such as chronic and repeated infection (e.g. diverticulitis) which may impair the use of C-REX RectoAid Cath
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the anastomotic leak rate within 30 days after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are: anastomotic leak rate at 90 days and 1 year postoperatively, intra- and postoperative complications, readmissions, the intra-operative effectiveness and efficiency of the C-REX device, surgeon satisfaction with the C-REX RectoAid Cath, time to evacuation of the anastomotic ring, quality of life, cost-effectiveness, and stoma-free survival. | — |
Countries
Netherlands
Outcome results
None listed