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

August 30, 2024 updated by: Fundación para la Investigación del Hospital Clínico de Valencia

Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers. A Randomized Multicentre Controlled Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
      • Murcia, Spain, 30120
        • Recruiting
        • Hospital Clínico Universitario Virgen de la Arrixaca
        • Contact:
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Not yet recruiting
        • Consorci Corporació Sanitària Parc Taulí de Sabadell
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECPS group
Echelon Circular™ Powered Stapler
Device: Echelon Circular™ Powered Stapler
Echelon Circular™ Powered Stapler will be used in colorectal anastomosis.
Active Comparator: MCS Group
2-row circular staplers manual
Device: 2-row circular staplers manual
2-row circular staplers manual will be used in colorectal anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomotic leakage rates differences between both groups at 30 postoperative days
Time Frame: 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).
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative endoluminal bleeding rate differences between both groups.
Time Frame: Through study completion, an average of 1 year
To assess whether ECPS improve haemostasis in the anastomotic line
Through study completion, an average of 1 year
Morbidity differences between groups according to the Clavien-Dindo classification.
Time Frame: Through study completion, an average of 1 year
To evaluate whether ECPS have an impact in postoperative morbidity
Through study completion, an average of 1 year
Re-intervention rate differences between both groups
Time Frame: Through study completion, an average of 1 year
To evaluate whether ECPS have an impact in re-interventions rate
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • EPCS-01-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Anastomosis

Clinical Trials on Echelon Circular™ Powered Stapler

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe