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

NCT03880747 | Completed

• 1 other identifier: SNUBHGS_VNP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Stomach Neoplasm

Outcome Measures

Primary Outcomes (1)

• Dumping syndrome

  Sigstad score of equal or more than 7

  1 year

Secondary Outcomes (3)

• EORTC C-30/STO22

  3 months, 6 months, 1 year

• Postoperative complication

  3 months, 6 months, 1 year

• Incidence of gallstones

  1 year

Other Outcomes (4)

• Operative time

  Immediately after operation

• Estimated blood loss

  Immediately after operation

• Time to first flatus

  Within 1 week

Study Arms (1)

Vagus nerve preserving group

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

Procedure: Vagus nerve-preserving distal gastrectomy

Interventions

Vagus nerve-preserving distal gastrectomy PROCEDURE

Laparoscopic distal gastrectomy with the preservation of the celiac and hepatic branch of the vagus nerve.

Vagus nerve preserving group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach planned to undergo laparoscopic vagus nerve-preserving distal gastrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: March 19, 2019
• Study Start: August 9, 2017
• Primary Completion: August 19, 2019
• Study Completion: August 20, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)