The First Affiliated Hospital with Nanjing Medical University
Phase
Not applicable
Started
2022-04
Last updated
2022-05-02
Condition(s) studied
Gastric Cancer
Investigational drug(s) / intervention(s)
Closure of the mesenteric defectsNon-closure of the mesenteric defects
Closure of the mesenteric defects: The surgically created mesenteric defects will be closed after radical gastrectomy with D1+/D2 lymph node dissection.
Non-closure of the mesenteric defects: The surgically created mesenteric defects will not be closed after radical gastrectomy with D1+/D2 lymph node dissection.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
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).
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangsu
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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