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

Stomach Neoplasm Clinical Trial

— VNP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880747
• Other study ID #: SNUBHGS_VNP
• Status: Completed
• Start date: August 9, 2017
• Est. completion date: August 20, 2020

Study information

• Verified date: March 2021
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 20, 2020
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dumping Syndrome
• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Procedure:
• Vagus nerve-preserving distal gastrectomy
Laparoscopic distal gastrectomy with the preservation of the celiac and hepatic branch of the vagus nerve.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operative time	Time of operation	Immediately after operation
Other	Estimated blood loss	Blood loss during operation	Immediately after operation
Other	Time to first flatus	Postoperative day to first flatus	Within 1 week
Other	Hospital stay	Total hospital stay	Within 1 week
Primary	Dumping syndrome	Sigstad score of equal or more than 7	1 year
Secondary	EORTC C-30/STO22	Quality of life surveys	3 months, 6 months, 1 year
Secondary	Postoperative complication	incidence of postoperative complication	3 months, 6 months, 1 year
Secondary	Incidence of gallstones	Found in follow-up CT or ultrasound	1 year