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

Completed

• Conditions: Stomach Neoplasm
• Interventions: Procedure: Vagus nerve-preserving distal gastrectomy

• Registration Number: NCT03880747
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2017-08-09
• Study First Submitted: 2019-03-17
• Study First Submitted QC: 2019-03-17
• Study First Posted: 2019-03-19
• Primary Completion: 2019-08-19
• Study Completion: 2020-08-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-07
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vagus nerve preserving group	Vagus nerve-preserving distal gastrectomy	Patients who underwent vagus nerve-preserving distal gastrectomy for early gastric cancer

Primary Outcome Measures

Name	Time	Method
Dumping syndrome	1 year	Sigstad score of equal or more than 7

Secondary Outcome Measures

Name	Time	Method
Incidence of gallstones	1 year	Found in follow-up CT or ultrasound
EORTC C-30/STO22	3 months, 6 months, 1 year	Quality of life surveys
Postoperative complication	3 months, 6 months, 1 year	incidence of postoperative complication

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of