The Safe Study of Routine Closure of Mesenteric Defects Versus Non-closure After Radical Gastrectomy

Nanjing Medical University

Status: Not yet enrolling

Conditions: Gastric Cancer

Treatments: Procedure: Closure of the mesenteric defects; Procedure: Non-closure of the mesenteric defects

Study type: Interventional

Funder types: Other

Identifiers

NCT05356156

JSGCU-2203

Details and patient eligibility

About

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).

Enrollment: 1,968 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,968 participants in 2 patient groups

Closure of the mesenteric defects

Experimental group

Description:

Closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.

Treatment:

Procedure: Closure of the mesenteric defects

Non-closure of the mesenteric defects

Active Comparator group

Description:

Non-closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.

Treatment:

Procedure: Non-closure of the mesenteric defects