NCT05556980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 18, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 25, 2024

Status Verified

October 1, 2022

Enrollment Period

2.3 years

First QC Date

September 18, 2022

Last Update Submit

September 23, 2024

Conditions

Postoperative Complications

Keywords

laparoscopy-assisted gastrectomytotally laparoscopic gastrectomydistal gastroectomypostoperative hospital staysurvivalcomplications

Outcome Measures

Primary Outcomes (1)

  • postoperative stay

    the time from the finish of surgery to discharge

    about one week to one month from the finish of surgery

Secondary Outcomes (1)

  • Survival

    3 year

Study Arms (2)

totally laparoscopic distal gastrectomy

EXPERIMENTAL

patients in this arm will receive totally laparoscopic distal gastrectomy

Procedure: totally laparoscopic distal gastrectomy

laparoscopy-assisted distal gastrectomy

NO INTERVENTION

patients in this group will receive laparoscopy-assisted distal gastrectomy

Interventions

totally laparoscopic distal gastrectomyPROCEDURE

all the surgical procedure would be finished under laparoscopy

totally laparoscopic distal gastrectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18-80 years old, no gender limitation;
  • primary gastric cancer and planed for distal gastrectomy;

You may not qualify if:

  • patients with total or proximal gastrectomy;
  • patients with distant metastasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xubing Zhang

Hefei, Other (Non U.s.), 230001, China

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the Outcomes Assessor would not know which approach the patient received.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

September 18, 2022

First Posted

September 27, 2022

Study Start

September 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 25, 2024

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

there is a plan to make individual participant data (IPD) available to other researchers.

Locations

CN(1)