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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03880747
Other study ID # SNUBHGS_VNP
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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