Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Man
Patients whom meet all eligibility criteria will be assigned random 1:1 to one of the following arms: * ECPS group: Echelon Circular™ Powered Stapler (n=270) * MCS Group: manual circular staplers (n=270) Patients will be followed during 30 days in order to evaluate the primary endpoint.
| Condition(s) | Colorectal Anastomosis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Patients whom meet all eligibility criteria will be assigned random 1:1 to one of the following arms: * ECPS group: Echelon Circular™ Powered Stapler (n=270) * MCS Group: manual circular staplers (n=270) Patients will be followed during 30 days in order to evaluate the primary endpoint. |
| Who can participate | Inclusion Criteria: * Patient or its legal representative informed consent. * Age ≥ 18 years. * Patients who will undergo a colorectal anastomosis after left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology (NOTE: Hartmann reversal cases also included). Exclusion Criteria: * Diverting stoma. * Emergency surgery. * American Society of Anaesthesiologists (ASA) score ≥ IV. * Transanal total mesorectal excision approach. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fundación para la Investigación del Hospital Clínico de Valencia |
| Locations | Sabadell, Barcelona, Spain; Madrid, Spain; Murcia, Spain; Valencia, Spain |
| Start date | 2024-06-27 |
| NCT ID | NCT06578065 |
| Official listing | https://clinicaltrials.gov/study/NCT06578065 |