RecruitingNot ApplicableNCT06464978
Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy
The Impact of Stapler Reinforcement Patches Compared to Standard Staplers on Postoperative Complications in Gastrojejunostomy: A Multicenter Randomized Controlled Trial
Sponsor
Nanchong Central Hospital
Enrollment
382 participants
Start Date
May 30, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria5
- 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.
Exclusion Criteria5
- Evidence of potential distant metastasis found preoperatively.
- History of other malignancies diagnosed within the past 5 years, or any malignancy treated with chemotherapy or radiotherapy.
- Significant contraindications for surgery (e.g., severe liver or kidney dysfunction).
- Participation in any other clinical trial within the last 6 months.
- Participants or their legal representatives unwilling to sign the informed consent or comply with the study protocol.
Interventions
DEVICEStapler Reinforcement Patch
Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches.
DEVICEStandard Stapler
Participants in this group will receive gastrojejunostomy with the use of Standard Stapler
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06464978
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