A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Mesenteric Defects Closure After Radical Gastrectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 1,968
- Locations
- 1
- Primary Endpoint
- The incidence of internal hernia within 3 years after surgery
Study Overview
Brief Summary
To compare the incidence of internal hernia, overall survival and short-term surgical safety of routine closure of the surgically created mesenteric defects versus non-closure for patients with adenocarcinoma of the gastric or esophagogastric junction who underwent radical gastrectomy (D1+/D2 lymph node dissection).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18-75 years；
- •Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；
- •The gastric primary lesion is located in the antrum, body or fundus of stomach or the esophagogastric junction. It is expected that radical gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)；
- •BMI(Body Mass Index) < 30 kg/m2；
- •No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；
- •No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.；
- •Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1；
- •Preoperative ASA (American Society of Anesthesiologists) scoring I-III；
- •Sufficient vital organ functions；
- •Signed informed consent.
Exclusion Criteria
- •Women during pregnancy or lactation；
- •Suffer from other malignant tumors within 5 years；
- •Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；
- •Severe mental illness；
- •Severe respiratory disease；
- •Severe liver and kidney dysfunction；
- •History of unstable angina or myocardial infarction within 6 months；
- •History of cerebral infarction or cerebral hemorrhage within 6 months；
- •Continuous application of glucocorticoid within 1 month (except for topical application)；
- •Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；
- •The patient has participated in or is participating in other clinical studies (within 6 months).
Arms & Interventions
Closure of the mesenteric defects
Closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.
Intervention: Closure of the mesenteric defects (Procedure)
Non-closure of the mesenteric defects
Non-closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.
Intervention: Non-closure of the mesenteric defects (Procedure)
Outcomes
Primary Outcomes
The incidence of internal hernia within 3 years after surgery
Time Frame: 3 years
Internal hernia were identified by surgical exploration or abdominal computed tomography (CT) from surgical and medical records during the postoperative 3 years of follow-up.
Secondary Outcomes
- Overall survival at 3 years after surgery(3 years)
- The incidence of intraoperative complications(up to 2 hours after surgery)
- Incidence of postoperative intestinal obstruction(3 years)