Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Echelon Circular™ Powered Stapler, 2-row circular staplers manual.
- Who it may be relevant to
- Registry conditions: Colorectal Anastomosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers. A Randomized Multicentre Controlled Trial.
Overview
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.
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.
Interventions
- Device Echelon Circular™ Powered Stapler
Echelon Circular™ Powered Stapler will be used in colorectal anastomosis. - Device 2-row circular staplers manual
2-row circular staplers manual will be used in colorectal anastomosis.
Primary outcome measures
- Anastomotic leakage rates differences between both groups at 30 postoperative days [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (3)
- Postoperative endoluminal bleeding rate differences between both groups. [Time frame: 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]
- Re-intervention rate differences between both groups [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 4 centers
- Consorci Corporació Sanitària Parc Taulí de Sabadell — Sabadell
- Hospital General Universitario Gregorio Marañón — Madrid
- Hospital Clínico Universitario Virgen de la Arrixaca — Murcia
- Hospital Clínico Universitario de Valencia — Valencia
Identifiers
NCT: NCT06578065 · EPCS-01-22