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

March 7, 2021 updated by: Hyung-Ho Kim, Seoul National University Bundang Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vagus nerve preserving group
Patients who underwent vagus nerve-preserving distal gastrectomy for early gastric cancer
Procedure: Vagus nerve-preserving distal gastrectomy
Laparoscopic distal gastrectomy with the preservation of the celiac and hepatic branch of the vagus nerve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dumping syndrome
Time Frame: 1 year
Sigstad score of equal or more than 7
1 year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Immediately after operation
Time of operation
Immediately after operation
Estimated blood loss
Time Frame: Immediately after operation
Blood loss during operation
Immediately after operation
Time to first flatus
Time Frame: Within 1 week
Postoperative day to first flatus
Within 1 week
Hospital stay
Time Frame: Within 1 week
Total hospital stay
Within 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 9, 2017

Primary Completion (ACTUAL)

August 19, 2019

Study Completion (ACTUAL)

August 20, 2020

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

March 17, 2019

First Posted (ACTUAL)

March 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 7, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBHGS_VNP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is currently no plan to share our IPD with other researchers unless needed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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