Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

NCT ID: NCT05556980

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
the Outcomes Assessor would not know which approach the patient received.

Study Groups

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totally laparoscopic distal gastrectomy

patients in this arm will receive totally laparoscopic distal gastrectomy

Group Type EXPERIMENTAL

totally laparoscopic distal gastrectomy

Intervention Type PROCEDURE

all the surgical procedure would be finished under laparoscopy

laparoscopy-assisted distal gastrectomy

patients in this group will receive laparoscopy-assisted distal gastrectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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totally laparoscopic distal gastrectomy

all the surgical procedure would be finished under laparoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Liu Liu

OTHER

Sponsor Role lead

Responsible Party

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Liu Liu

Clinical professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Xubing Zhang

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

Site Status

Countries

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China

Other Identifiers

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TLDG

Identifier Type: -

Identifier Source: org_study_id

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