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

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ClinicalTrials.gov Identifier: NCT03880747
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hyung-Ho Kim, Seoul National University Bundang Hospital

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).

Condition or disease Intervention/treatment
Stomach Neoplasm Procedure: Vagus nerve-preserving distal gastrectomy

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Dumping Syndrome After Laparoscopic Vagus Nerve-preserving Distal Gastrectomy for Early Gastric Cancer
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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.




Primary Outcome Measures :
  1. Dumping syndrome [ Time Frame: 1 year ]
    Sigstad score of equal or more than 7


Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880747


Contacts
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Contact: Hyung-Ho Kim, PhD +82-31-787-7099 hhkim@snubh.org,

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 13620
Contact: Hyung-Ho Kim, PhD    +82-31-787-7099    hhkim@gmail.com   
Sponsors and Collaborators
Seoul National University Bundang Hospital

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Responsible Party: Hyung-Ho Kim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03880747     History of Changes
Other Study ID Numbers: SNUBHGS_VNP
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is currently no plan to share our IPD with other researchers unless needed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stomach Neoplasms
Dumping Syndrome
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Postgastrectomy Syndromes
Postoperative Complications
Pathologic Processes