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

Seoul National University

Status: Completed

Conditions: Stomach Neoplasm

Treatments: Procedure: Vagus nerve-preserving distal gastrectomy

Study type: Observational

Funder types: Other

Identifiers

NCT03880747

SNUBHGS_VNP

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Vagus nerve preserving group

Description:

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

Treatment:

Procedure: Vagus nerve-preserving distal gastrectomy