Totally Laparoscopic Distal Gastrectomy for Gastric Cancer (TLDG)

October 1, 2022 updated by: Liu Liu

Randomized Controlled Trial Comparing the Outcomes of Totally Laparoscopic Distal Gastrectomy and Laparoscopy-assisted Gastrectomy for Gastric Cancer

This study was designed as a randomized clinical trial comparing the totally laparoscopic distal gastrectomy with laparoscopy-assisted distal gastroectomy for patients with gastric cancer, in terms of short-term and long-term outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

When one patient was enrolled, he will be randomly divided into experimental group (totally laparoscopic distal gastrectomy) or control group (laparoscopy-assisted distal gastrectomy). When he receives surgery, intraoperative parameters would be recorded. when the patient discharges, the routine follow-up would be regularly performed for the survival.

Study Type

Interventional

Enrollment (Anticipated)

120

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 Locations

  • China
    • Other (Non U.s.)
      • Hefei, Other (Non U.s.), China, 230001
        • Recruiting
        • Xubing Zhang
        • Contact:

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • aged 18-80 years old, no gender limitation;
  • primary gastric cancer and planed for distal gastrectomy;

Exclusion Criteria:

  • patients with total or proximal gastrectomy;
  • patients with distant metastasis.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: totally laparoscopic distal gastrectomy
patients in this arm will receive totally laparoscopic distal gastrectomy
Procedure: totally laparoscopic distal gastrectomy
all the surgical procedure would be finished under laparoscopy
No Intervention: laparoscopy-assisted distal gastrectomy
patients in this group will receive laparoscopy-assisted distal gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative stay
Time Frame: about one week to one month from the finish of surgery
the time from the finish of surgery to discharge
about one week to one month from the finish of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 3 year
the survival rate at the third year from the finish of surgery
3 year

Collaborators and Investigators

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

Sponsor

Liu Liu

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 (Actual)

September 1, 2021

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

August 31, 2026

Study Registration Dates

First Submitted

September 18, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 1, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLDG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

there is a plan to make individual participant data (IPD) available to other researchers.

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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