Gastric Cancer
Conditions
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).
Interventions
PROCEDUREClosure of the mesenteric defects
The surgically created mesenteric defects will be closed after radical gastrectomy with D1+/D2 lymph node dissection.
PROCEDURENon-closure of the mesenteric defects
The surgically created mesenteric defects will not be closed after radical gastrectomy with D1+/D2 lymph node dissection.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactZekuan Xu, M.D., Ph.D.
Outcome results
None listed