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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postoperative Complications | Procedure: totally laparoscopic distal gastrectomy | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: totally laparoscopic distal gastrectomy
patients in this arm will receive totally laparoscopic distal gastrectomy
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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
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- postoperative stay [ Time Frame: about one week to one month from the finish of surgery ]the time from the finish of surgery to discharge
- Survival [ Time Frame: 3 year ]the survival rate at the third year from the finish of surgery
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.
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
China, Other (Non U.s.) | |
Xubing Zhang | Recruiting |
Hefei, Other (Non U.s.), China, 230001 | |
Contact: Xubing Zhang +8618428374478 2421770462@qq.com |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
laparoscopy-assisted gastrectomy totally laparoscopic gastrectomy distal gastroectomy |
postoperative hospital stay survival complications |
Postoperative Complications Pathologic Processes |