RecruitingNot ApplicableNCT06578065

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.


Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Enrollment

540 participants

Start Date

Jun 27, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called 2-row circular staplers manual and a medical device called Echelon Circular™ Powered Stapler for people with colorectal anastomosis. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEchelon Circular™ Powered Stapler

Echelon Circular™ Powered Stapler will be used in colorectal anastomosis.

DEVICE2-row circular staplers manual

2-row circular staplers manual will be used in colorectal anastomosis.


Locations(4)

Consorci Corporació Sanitària Parc Taulí de Sabadell

Sabadell, Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

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NCT06578065


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