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

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Enrolling

Conditions: Colorectal Anastomosis

Treatments: Device: Echelon Circular™ Powered Stapler; Device: 2-row circular staplers manual

Study type: Interventional

Funder types: Other

Identifiers

NCT06578065

EPCS-01-22

Details and patient eligibility

About

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.

Full description

Anastomotic Leakage (AL) is the complication that most concerns colorectal surgeons. It leads to prolonged postoperative stay, increased costs, risk of reoperations and a permanent colostomy, together with an increase in morbidity and mortality.

The novel Echelon Circular™ Powered Stapler (ECPS) (Ethicon, Somerville, NJ, USA), introduces design changes that could decrease the rate of technical errors and improve clinical outcomes. The powered stapler decreases the force needed on firing the device, improving stability at the anastomotic site. Atraumatic Gripping Surface Technology reduces the compressive forces on tissues, and along with 3D Stapling Technology allows a better compression distribution throughout the anastomosis and a better hemostasis.

This is a multicenter, randomized, open-label, controlled with parallel groups clinical trial, with 8 participant sites in total (4 sites in Spain and 4 sites in France), to include an approximate sample size (n) of 570 patients who will undergo a colorectal anastomosis after Hartmann reversal, left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology.

540 patients assigned randomly 1:1 to assess whether technical improvements of Echelon Circular™ Powered Stapler (ECPS) have an impact on left-sided colorectal Anastomotic Leakage (AL) rate compared to current manual circular staplers (MCS).

Anastomosis could be performed open, laparoscopically or with robotic assistance.

After surgery, patients will be followed during 30 days in order to evaluate the primary endpoint.

Enrollment: 540 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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540 participants in 2 patient groups

ECPS group

Experimental group

Description:

Echelon Circular™ Powered Stapler

Treatment:

Device: Echelon Circular™ Powered Stapler

MCS Group

Active Comparator group

Description:

2-row circular staplers manual

Treatment:

Device: 2-row circular staplers manual