Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05356156

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

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location contact

Zekuan Xu, M.D., Ph.D.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Closure of the mesenteric defects

Procedure

The surgically created mesenteric defects will be closed after radical gastrectomy with D1+/D2 lymph node dissection.

Non-closure of the mesenteric defects

Procedure

The surgically created mesenteric defects will not be closed after radical gastrectomy with D1+/D2 lymph node dissection.

Primary outcomes

  1. The incidence of internal hernia within 3 years after surgery

    Time frame: 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 outcomes

  1. The incidence of intraoperative complications

    Time frame: 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.

  2. Incidence of postoperative intestinal obstruction

    Time frame: 3 years

    Refers to the incidence of postoperative intestinal obstruction observed during follow-up period.

  3. Overall survival at 3 years after surgery

    Time frame: 3 years

    The overall survival of patients with gastric or esophagogastric junction adenocarcinoma are evaluated at 3 years after radical gastrectomy.

Study contacts

Contact information is provided by the study sponsor or research team.

Zekuan Xu, M.D., Ph.D.

CONTACT

[email protected]

+86-025-68306844

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 2, 2022
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.