Dumping Syndrome and Quality of Life After Vagus Nerve-preserving Distal Gastrectomy

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

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-09

Study Completion Date

2020-08-20

Brief Summary

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There is no consensus on what type of function-preserving gastrectomy can provide the best patient quality of life (QOL). This study aims to evaluate the incidence of dumping syndrome after vagus nerve-preserving distal gastrectomy (VPNDG).

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Detailed Description

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The study is designed as a prospective observational phase II study with a follow-up period of 12 months. Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach who are planned to undergo laparoscopic VPNDG with Roux-en Y gastrojejunostomy will be enrolled. Primary endpoint is incidence of dumping syndrome defined by Sigstad score 7 after a 3-month interval. Other outcomes include operative data, early complication, and patient QOL using the European Organization for Research and Treatment of Cancer C-30 and STO22 modules.

Conditions

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Stomach Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vagus nerve preserving group

Patients who underwent vagus nerve-preserving distal gastrectomy for early gastric cancer

Vagus nerve-preserving distal gastrectomy

Intervention Type PROCEDURE

Laparoscopic distal gastrectomy with the preservation of the celiac and hepatic branch of the vagus nerve.

Interventions

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Vagus nerve-preserving distal gastrectomy

Laparoscopic distal gastrectomy with the preservation of the celiac and hepatic branch of the vagus nerve.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach planned to undergo laparoscopic vagus nerve-preserving distal gastrectomy

Exclusion Criteria

* Sacrificed vagus nerve
* Anastomosis other than Roux-en Y gastrojejunostomy or uncut Roux-en Y gastrojejunostomy
* conversion to an open procedure
* combined resection of other organs

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No