About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Diverting stoma.
Emergency surgery.
American Society of Anaesthesiologists (ASA) score ≥ IV.
Transanal total mesorectal excision approach.
Trial design
Parallel
Treatments tested in this trial
Echelon Circular™ Powered Stapler
DeviceEchelon Circular™ Powered Stapler will be used in colorectal anastomosis.
2-row circular staplers manual
Device2-row circular staplers manual will be used in colorectal anastomosis.
Treatment groups
Trial outcomes
Primary outcomes
Anastomotic leakage rates differences between both groups at 30 postoperative days
To assess whether ECPS have an impact on left-sided colorectal AL rate compared to current manual circular staplers (MCS).
Secondary outcomes
Postoperative endoluminal bleeding rate differences between both groups.
To assess whether ECPS improve haemostasis in the anastomotic line
Morbidity differences between groups according to the Clavien-Dindo classification.
To evaluate whether ECPS have an impact in postoperative morbidity
Re-intervention rate differences between both groups
To evaluate whether ECPS have an impact in re-interventions rate
Sponsors and contacts
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