Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stapler Reinforcement Patch, Standard Stapler.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Gastrostomy, Anastomotic Leakage, Postoperative Complications. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of Stapler Reinforcement Patches Compared to Standard Staplers on Postoperative Complications in Gastrojejunostomy: A Multicenter Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Device Stapler Reinforcement Patch
Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches. - Device Standard Stapler
Participants in this group will receive gastrojejunostomy with the use of Standard Stapler
Primary outcome measures
- Rate of Anastomotic Leakage [Time frame: 30 days post-surgery]
Secondary outcome measures (4)
- Rate of Anastomotic Stricture [Time frame: 3 months post-surgery]
- Postoperative Bleeding Rate [Time frame: 30 days post-surgery]
- Mortality Rate [Time frame: 30 days post-surgery]
- Readmission Rate [Time frame: 3 months post-surgery]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Yunhong Tian — Nanchong
Identifiers
NCT: NCT06464978 · 20240530