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Totally Laparoscopic Distal Gastrectomy for Gastric Cancer (TLDG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05556980
Recruitment Status : Recruiting
First Posted : September 27, 2022
Last Update Posted : October 4, 2022
Sponsor:
Information provided by (Responsible Party):
Liu Liu, The First Affiliated Hospital of University of Science and Technology of China

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Complications Procedure: totally laparoscopic distal gastrectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: the Outcomes Assessor would not know which approach the patient received.
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing the Outcomes of Totally Laparoscopic Distal Gastrectomy and Laparoscopy-assisted Gastrectomy for Gastric Cancer
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. postoperative stay [ Time Frame: about one week to one month from the finish of surgery ]
    the time from the finish of surgery to discharge


Secondary Outcome Measures :
  1. Survival [ Time Frame: 3 year ]
    the survival rate at the third year from the finish of surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05556980


Locations
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China, Other (Non U.s.)
Xubing Zhang Recruiting
Hefei, Other (Non U.s.), China, 230001
Contact: Xubing Zhang    +8618428374478    2421770462@qq.com   
Sponsors and Collaborators
Liu Liu
More Information
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Responsible Party: Liu Liu, Clinical professor, The First Affiliated Hospital of University of Science and Technology of China
ClinicalTrials.gov Identifier: NCT05556980    
Other Study ID Numbers: TLDG
First Posted: September 27, 2022    Key Record Dates
Last Update Posted: October 4, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there is a plan to make individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liu Liu, The First Affiliated Hospital of University of Science and Technology of China:
laparoscopy-assisted gastrectomy
totally laparoscopic gastrectomy
distal gastroectomy
 postoperative hospital stay
survival
complications
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes