Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.

Recruiting now · Not applicable

Conditions studied: Colorectal Anastomosis

In brief

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.

Key facts

Study ID

NCT06578065

Run by

Fundación para la Investigación del Hospital Clínico de Valencia

People needed

540

Starts

2024-06-27

Expected to finish

2026-09-01

Last updated by the study team

2024-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Diverting stoma.
• Emergency surgery.
• American Society of Anaesthesiologists (ASA) score ≥ IV.
• Transanal total mesorectal excision approach.

Where it is running

• Hospital General Universitario Gregorio Marañón — Madrid, Spain (enrolling)
• Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Spain (enrolling)
• Hospital Clínico Universitario de Valencia — Valencia, Spain (enrolling)
• Consorci Corporació Sanitària Parc Taulí de Sabadell — Sabadell, Barcelona, Spain

Full record on ClinicalTrials.gov

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