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

Not Applicable

Not yet recruiting

• Conditions: Gastric Cancer
• Interventions: Procedure: Non-closure of the mesenteric defects; Procedure: Closure of the mesenteric defects

• Registration Number: NCT05356156
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study Start: 2022-04
• Study First Submitted: 2022-04-23
• Study First Submitted QC: 2022-04-29
• Last Update Submitted: 2022-04-29
• Study First Posted: 2022-05-02
• Last Update Posted: 2022-05-02
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1968

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The incidence of internal hernia within 3 years after surgery	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 Outcome Measures

Name	Time	Method
Overall survival at 3 years after surgery	3 years	The overall survival of patients with gastric or esophagogastric junction adenocarcinoma are evaluated at 3 years after radical gastrectomy.
The incidence of intraoperative complications	up to 2 hours after surgery	The intraoperative complications occur from the beginning of skin cutting to the completion of sewn skin, including surgical complications, anesthesia related complications and pneumoperitoneum related complications.
Incidence of postoperative intestinal obstruction	3 years	Refers to the incidence of postoperative intestinal obstruction observed during follow-up period.

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China