NCT03880747

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

Incidence of Dumping Syndrome After Laparoscopic Vagus Nerve-preserving Distal Gastrectomy for Early Gastric Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stomach Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Vagus nerve-preserving distal gastrectomy	Laparoscopic distal gastrectomy with the preservation of the celiac and hepatic branch of the vagus nerve.

Timeline

• Start date: 2017-08-09
• Primary completion: 2019-08-19
• Completion: 2020-08-20
• First posted: 2019-03-19
• Last updated: 2021-03-09

Locations

1 site across 1 country: South Korea