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Not yet recruiting NCT05356156

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

No phase Interventional Gastric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Closure of the mesenteric defects, Non-closure of the mesenteric defects.
Who it may be relevant to
Registry conditions: Gastric Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Mesenteric Defects Closure After Radical Gastrectomy

Overview

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

  • Procedure Closure of the mesenteric defects
    The surgically created mesenteric defects will be closed after radical gastrectomy with D1+/D2 lymph node dissection.
  • Procedure Non-closure of the mesenteric defects
    The surgically created mesenteric defects will not be closed after radical gastrectomy with D1+/D2 lymph node dissection.

Primary outcome measures

  • The incidence of internal hernia within 3 years after surgery [Time frame: 3 years]
Secondary outcome measures (3)
  • The incidence of intraoperative complications [Time frame: up to 2 hours after surgery]
  • Incidence of postoperative intestinal obstruction [Time frame: 3 years]
  • Overall survival at 3 years after surgery [Time frame: 3 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Nanjing Medical University — Nanjing

Identifiers

NCT: NCT05356156 · JSGCU-2203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗