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

NCT06578065 · tracked via the Priya Life Science Spain tracker

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Phase

Not applicable

Started

2024-06-27

Last updated

2026-09-09

Condition(s) studied

Colorectal Anastomosis

Investigational drug(s) / intervention(s)

Echelon Circular™ Powered Stapler2-row circular staplers manual

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

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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Anastomotic leakage rates differences between both groups at 30 postoperative days — Through study completion, an average of 1 year
To assess whether ECPS have an impact on left-sided colorectal AL rate compared to current manual circular staplers (MCS).

Trial sites (4)

Facility	City	Region	Status
Consorci Corporació Sanitària Parc Taulí de Sabadell	Sabadell	Barcelona	Not Yet Recruiting
Hospital General Universitario Gregorio Marañón	Madrid	Spain	Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca	Murcia	Spain	Recruiting
Hospital Clínico Universitario de Valencia	Valencia	Spain	Recruiting

More Fundación para la Investigación del Hospital Clínico de Valencia trials in Spain

Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure Active, not recruiting

Tissue Characterization in STEMI Using Cardiac MRI: a Multicenter Registry Active, not recruiting

Is the 3D-PANC MSP Model Superior to CT for Assessing Response to Neoadjuvant Treatment in PCA Patients? Recruiting

Exercise-Based Cardiac Rehabilitation for Patients With Heart Failure With Preserved Ejection Fraction (EMPOWER-HFpEF) Starting soon

Personalised Health Recommendations to the General Population Through an Integrated AI Guided Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06578065 on ClinicalTrials.gov ↗ ← All trials in Spain