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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

Tracking Information
First Submitted Date  ICMJE September 18, 2022
First Posted Date  ICMJE September 27, 2022
Last Update Posted Date October 4, 2022
Actual Study Start Date  ICMJE September 1, 2021
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2022)		 postoperative stay [ Time Frame: about one week to one month from the finish of surgery ]
the time from the finish of surgery to discharge
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2022)		 postoperative stays [ Time Frame: about one week to one month from the finish of surgery ]
the time from the finish of surgery to discharge
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2022)		 Survival [ Time Frame: 3 year ]
the survival rate at the third year from the finish of surgery
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2022)		 3-year overall survival [ Time Frame: 3 year ]
the survival rate at the third year from the finish of surgery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
Official Title  ICMJE Randomized Controlled Trial Comparing the Outcomes of Totally Laparoscopic Distal Gastrectomy and Laparoscopy-assisted Gastrectomy for Gastric Cancer
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Postoperative Complications
Intervention  ICMJE Procedure: totally laparoscopic distal gastrectomy
all the surgical procedure would be finished under laparoscopy
Study Arms  ICMJE
  • Experimental: totally laparoscopic distal gastrectomy
    patients in this arm will receive totally laparoscopic distal gastrectomy
    Intervention: Procedure: totally laparoscopic distal gastrectomy
  • No Intervention: laparoscopy-assisted distal gastrectomy
    patients in this group will receive laparoscopy-assisted distal gastrectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2022)		 120
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2022)		 140
Estimated Study Completion Date  ICMJE August 31, 2026
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05556980
Other Study ID Numbers  ICMJE TLDG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: there is a plan to make individual participant data (IPD) available to other researchers.
Current Responsible Party Liu Liu, The First Affiliated Hospital of University of Science and Technology of China
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Liu Liu
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First Affiliated Hospital of University of Science and Technology of China
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP