Factors Affecting the Difficulty of Laparoscopic D2 Lymph Node Dissection for Gastric Cancer

Factors Affecting the Difficulty of Laparoscopic D2 Lymph Node Dissection for Gastric Cancer:a Retrospective Cohort Study

Laparoscopic D2 lymph node dissection (LND) for gastric cancer has a wide range of operations and a high degree of difficulty.The purpose of this study was to evaluate the relationship between clinicopathological factors and the difficulty of laparoscopic D2 LND.

Study Overview

• Status: Completed
• Conditions: Surgery-Complications
• Intervention / Treatment: Other: Whether lymph node dissection is qualified or not

• Study Type: Observational
• Enrollment (Actual): 187

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Department of Gastric Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The CLASS-01 trial is a prospective multicenter randomized controlled study (ClinicalTrials.gov.number:NCT01609309) to compare the oncological efficacy of laparoscopy and laparotomy in the treatment of locally advanced distal gastric cancer. In this study, 119 patients who underwent laparoscopic surgery at our center who participated in CLASS-01 were selected. All the patients were operated with 2D laparoscopic system.The 2D/3D trial is a prospective clinical trial (ClinicalTrials.gov.number:NCT02327481) that compares the curative effect of 2D and 3D laparoscopic radical gastrectomy in our center. Seventy cases of 2D laparoscopic distal gastrectomy (LDG) were selected

Description

Inclusion Criteria:

1. all patients undergoing laparoscopic surgery
2. Laparoscopic system is 2D and has complete D2 lymph node dissection.

Exclusion Criteria:

1. patients undergoing laparotomy
2. incomplete video or clinicopathological information

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
qualified of D2 Lymph node dissection group	Other: Whether lymph node dissection is qualified or not; Klass-02-QC LND scale and general error score tool were used to quantitatively evaluate the intraoperative performance of D2 LND
not-qualified D2 Lymph node dissection group	Other: Whether lymph node dissection is qualified or not; Klass-02-QC LND scale and general error score tool were used to quantitatively evaluate the intraoperative performance of D2 LND

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgery complicated	Incidence of operative complications between qualified group and unqualified group	30 days after operation

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): May 10, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: October 15, 2022
• First Submitted That Met QC Criteria: October 15, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 15, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: SD-GC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No