Colorectal Anastomosis
Conditions
Brief 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.
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
DEVICEEchelon Circular™ Powered Stapler
Echelon Circular™ Powered Stapler will be used in colorectal anastomosis.
DEVICE2-row circular staplers manual
2-row circular staplers manual will be used in colorectal anastomosis.
Sponsors
Fundación para la Investigación del Hospital Clínico de Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A multicenter, randomized, open-label, controlled with parallel groups clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative endoluminal bleeding rate differences between both groups. | Through study completion, an average of 1 year | To assess whether ECPS improve haemostasis in the anastomotic line |
| Morbidity differences between groups according to the Clavien-Dindo classification. | Through study completion, an average of 1 year | To evaluate whether ECPS have an impact in postoperative morbidity |
| Re-intervention rate differences between both groups | Through study completion, an average of 1 year | To evaluate whether ECPS have an impact in re-interventions rate |
Countries
Spain
Contacts
CONTACTVicente Pla Martí
Outcome results
None listed