Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578065
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers A Randomized Multicentre Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients whom meet all eligibility criteria will be assigned random 11 to one of the following arms
ECPS group Echelon Circular Powered Stapler n270
MCS Group manual circular staplers n270 Patients will be followed during 30 days in order to evaluate the primary endpoint
ECPS group Echelon Circular Powered Stapler n270
MCS Group manual circular staplers n270 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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None