Back to resultsTotally Laparoscopic Distal Gastrectomy for Gastric Cancer (TLDG)
Primary Purpose
Postoperative Complications
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
totally laparoscopic distal gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications focused on measuring laparoscopy-assisted gastrectomy, totally laparoscopic gastrectomy, distal gastroectomy, postoperative hospital stay, survival, complications
Eligibility 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.
Sites / Locations
- Xubing ZhangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
totally laparoscopic distal gastrectomy
laparoscopy-assisted distal gastrectomy
Arm Description
patients in this arm will receive totally laparoscopic distal gastrectomy
patients in this group will receive laparoscopy-assisted distal gastrectomy
Outcomes
Primary Outcome Measures
postoperative stay
the time from the finish of surgery to discharge
Secondary Outcome Measures
Survival
the survival rate at the third year from the finish of surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05556980
Brief Title
Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
Acronym
TLDG
Official Title
Randomized Controlled Trial Comparing the Outcomes of Totally Laparoscopic Distal Gastrectomy and Laparoscopy-assisted Gastrectomy for Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Liu Liu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
laparoscopy-assisted gastrectomy, totally laparoscopic gastrectomy, distal gastroectomy, postoperative hospital stay, survival, complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
the Outcomes Assessor would not know which approach the patient received.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
totally laparoscopic distal gastrectomy
Arm Type
Experimental
Arm Description
patients in this arm will receive totally laparoscopic distal gastrectomy
Arm Title
laparoscopy-assisted distal gastrectomy
Arm Type
No Intervention
Arm Description
patients in this group will receive laparoscopy-assisted distal gastrectomy
Intervention Type
Procedure
Intervention Name(s)
totally laparoscopic distal gastrectomy
Intervention Description
all the surgical procedure would be finished under laparoscopy
Primary Outcome Measure Information:
Title
postoperative stay
Description
the time from the finish of surgery to discharge
Time Frame
about one week to one month from the finish of surgery
Secondary Outcome Measure Information:
Title
Survival
Description
the survival rate at the third year from the finish of surgery
Time Frame
3 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Xubing Zhang
City
Hefei
State/Province
Other (Non U.s.)
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xubing Zhang
Phone
+8618428374478
Email
2421770462@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
there is a plan to make individual participant data (IPD) available to other researchers.
Learn more about this trial
Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
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