Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.
Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers. A Randomized Multicentre Controlled Trial.
Fundación para la Investigación del Hospital Clínico de Valencia
540 participants
Jun 27, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria4
- Diverting stoma.
- Emergency surgery.
- American Society of Anaesthesiologists (ASA) score ≥ IV.
- Transanal total mesorectal excision approach.
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Interventions
Echelon Circular™ Powered Stapler will be used in colorectal anastomosis.
2-row circular staplers manual will be used in colorectal anastomosis.
Locations(4)
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NCT06578065