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

April 29, 2022 updated by: The First Affiliated Hospital with Nanjing Medical University

A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Mesenteric Defects 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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1968

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
          • Zekuan Xu, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Closure of the mesenteric defects
Closure of the mesenteric defects will be performed after radical gastrectomy in patients with gastric or esophagogastric junction adenocarcinoma.
Procedure: Closure of the mesenteric defects
The surgically created mesenteric defects will be closed after radical gastrectomy with D1+/D2 lymph node dissection.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 2 hours after surgery
Incidence of postoperative intestinal obstruction
Time Frame: 3 years
Refers to the incidence of postoperative intestinal obstruction observed during follow-up period.
3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Zekuan Xu, M.D., Ph.D., The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

March 1, 2027

Study Completion (Anticipated)

March 1, 2027

Study Registration Dates

First Submitted

April 23, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSGCU-2203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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