The Impact of Stapler Reinforcement Patches Compared to Standard Staplers on Postoperative Complications in Gastrojejunostomy: A Multicenter Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
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• Age between 18 and 85 years.
• Pathologically diagnosed with gastric cancer and suitable for distal gastrectomy or subtotal gastrectomy.
• ECOG performance status of 0 or 1.
• ASA (American Society of Anesthesiologists) classification of I-III.
• Voluntary signed informed consent from the participant or their legal representative.
Locations
Other Locations
China
Yunhong Tian
RECRUITING
Nanchong
Time Frame
Start Date: 2024-05-30
Estimated Completion Date: 2026-06
Participants
Target number of participants: 382
Treatments
Experimental: Stapler Reinforcement Patch Group
Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches.
Active_comparator: Standard Stapler Group
Participants in this group will receive gastrojejunostomy with the use of standard staplers.
Related Therapeutic Areas
Sponsors
Collaborators: Yilong County people's Hospital, Nanbu Hospital of County Chinese Medicine, Langzhong People's Hospital, Guang'an Central Hospital, Pengan County People's Hospital
Leads: Nanchong Central Hospital