TLDG: Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

• Sponsor: Liu Liu (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05556980
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Complications	Procedure: totally laparoscopic distal gastrectomy	N/A

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

• Study Type: Interventional
• Anticipated 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: Sep 1, 2021
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Aug 31, 2026

Arms and Interventions

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

Primary Outcome Measures

1. postoperative stay [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 [3 year]

   the survival rate at the third year from the finish of surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xubing Zhang	Hefei	Other (Non U.s.)	China	230001

Sponsors and Collaborators

• Liu Liu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Sep 27, 2022
• Last Update Posted: Oct 4, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Liu Liu, Clinical professor, 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: Postoperative Complications

Study Results

No Results Posted as of Oct 4, 2022