This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.
This study compares stapler reinforcement patches with standard staplers in gastrojejunostomy to reduce postoperative complications. It aims to demonstrate the effectiveness and safety of these patches in preventing anastomotic leakage and other related complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
382
Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches.
Participants in this group will receive gastrojejunostomy with the use of Standard Stapler
Yunhong Tian
Nanchong, Sichuan, China
RECRUITINGRate of Anastomotic Leakage
The incidence of anastomotic leakage within 30 days post-surgery. Anastomotic leakage is defined as the presence of fluid containing enteric content in the abdominal cavity or the appearance of leakage confirmed by imaging or endoscopy.
Time frame: 30 days post-surgery
Rate of Anastomotic Stricture
The incidence of anastomotic stricture within 3 months post-surgery. Anastomotic stricture is defined as difficulty in food passage or narrowing confirmed by imaging or endoscopy.
Time frame: 3 months post-surgery
Postoperative Bleeding Rate
The incidence of postoperative bleeding within 30 days post-surgery. Postoperative bleeding is defined as the occurrence of bleeding requiring intervention or causing significant hemoglobin drop.
Time frame: 30 days post-surgery
Mortality Rate
The rate of mortality within 30 days post-surgery.
Time frame: 30 days post-surgery
Readmission Rate
Readmission Rate
Time frame: 3 months post-surgery
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