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Completed

NCT Number: NCT03880747

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vagus nerve-preserving distal gastrectomy

Procedure

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

Primary outcomes

  1. Dumping syndrome

    Time frame: 1 year

    Sigstad score of equal or more than 7

Secondary outcomes

  1. EORTC C-30/STO22

    Time frame: 3 months, 6 months, 1 year

    Quality of life surveys

  2. Postoperative complication

    Time frame: 3 months, 6 months, 1 year

    incidence of postoperative complication

  3. Incidence of gallstones

    Time frame: 1 year

    Found in follow-up CT or ultrasound

Other outcomes

  1. Operative time

    Time frame: Immediately after operation

    Time of operation

  2. Estimated blood loss

    Time frame: Immediately after operation

    Blood loss during operation

  3. Time to first flatus

    Time frame: Within 1 week

    Postoperative day to first flatus

  4. Hospital stay

    Time frame: Within 1 week

    Total hospital stay

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Acronym: VNP

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 19, 2019
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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