An interventional study of Echelon Circular™ Powered Stapler and 2-row circular staplers manual in Colorectal Anastomosis, sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. Recruiting at 4 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Fundación para la Investigación del Hospital Clínico de Valencia · Not applicable, Interventional, and Treatment
Patients whom meet all eligibility criteria will be assigned random 1:1 to one of the following arms:
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.
Exclusion Criteria:
Echelon Circular™ Powered Stapler
Device: Echelon Circular™ Powered Stapler
2-row circular staplers manual
Device: 2-row circular staplers manual
Echelon Circular™ Powered Stapler will be used in colorectal anastomosis.
2-row circular staplers manual will be used in colorectal anastomosis.
Anastomotic leakage rates differences between both groups at 30 postoperative days
To assess whether ECPS have an impact on left-sided colorectal AL rate compared to current manual circular staplers (MCS).
Time frame: Through study completion, an average of 1 year
Postoperative endoluminal bleeding rate differences between both groups.
To assess whether ECPS improve haemostasis in the anastomotic line
Time frame: Through study completion, an average of 1 year
Morbidity differences between groups according to the Clavien-Dindo classification.
To evaluate whether ECPS have an impact in postoperative morbidity
Time frame: Through study completion, an average of 1 year
Re-intervention rate differences between both groups
To evaluate whether ECPS have an impact in re-interventions rate
Time frame: Through study completion, an average of 1 year
Plan to share: No
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Fundación para la Investigación del Hospital Clínico de Valencia