Anastomotic Leakage, Gastric Cancer, Gastrostomy, Postoperative Complications
Conditions
Keywords
Stapler Reinforcement Patch, Gastrojejunostomy, Randomized Controlled Trial, Surgical Outcomes, Complication Prevention
Brief 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.
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
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
Sponsors
Nanchong Central Hospital
Guang'an Central Hospital
Pengan County People's Hospital
Yilong County people's Hospital
Nanbu Hospital of County Chinese Medicine
Langzhong People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcomes assessors will be blinded to the group assignments. Surgeons will be aware of the group assignments but will not disclose this information to the participants or the outcomes assessors.
Intervention model description
Participants will be randomly assigned to either the experimental group receiving the stapler reinforcement patches or the control group undergoing standard procedures without reinforcement patches.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Anastomotic Leakage | 30 days post-surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Anastomotic Stricture | 3 months post-surgery | 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. |
| Postoperative Bleeding Rate | 30 days post-surgery | 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. |
| Mortality Rate | 30 days post-surgery | The rate of mortality within 30 days post-surgery. |
| Readmission Rate | 3 months post-surgery | Readmission Rate |
Countries
China
Outcome results
None listed