The Model for End-Stage Liver Disease Sodium (MELD-Na) Score in Non-cirrhotic Patients With Gastric Cancer

Sponsor
Istanbul Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04791293
Collaborator
(none)
159
1
20.1
7.9

Study Details

Study Description

Brief Summary

Gastric cancer is the fifth most common cancer worldwide. Gastrectomy with lymphadenectomy is still the most effective treatment modality, depending on the stage and location. Despite many radiological, surgical and anesthetic innovations, serious complications such as anastomotic leakage, intra-abdominal abscesses, wound complications are seen secondary to gastrectomy. Many clinical studies have been conducted to prevent and predict these complications.

The Model for End-Stage Liver Disease (MELD) score, in which bilirubin, international normalized ratio (INR) and serum creatinine values were used to determine surgical risks in patients scheduled for liver transplantation. Latter developed by adding serum sodium (Na) to the formula. The MELD-Na score is used to predict postoperative complications in non-cirrhotic patients because of its simple and easy calculation.Moreover, The Meld-Na score was later used to predict complications for surgical procedures other than liver surgery such as colorectal surgery.

In this study, we aimed to investigate the importance of the Meld-Na score in predicting the perioperative and postoperative outcomes in patients with gastric cancer.

Condition or Disease Intervention/Treatment Phase
  • Other: MELD-Na score

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
159 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predictive Value of MELD-Na Score for Perioperative Complications in Non-cirrhotic Patients With Gastric Cancer
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Aug 5, 2022
Actual Study Completion Date :
Aug 5, 2022

Arms and Interventions

Arm Intervention/Treatment
Group 1

Patients with postoperative complications

Other: MELD-Na score
MELD-Na scores will be compared between the groups

Group 2

Patients without postoperative complications

Other: MELD-Na score
MELD-Na scores will be compared between the groups

Outcome Measures

Primary Outcome Measures

  1. MELD-Na score difference between the groups [30 days]

    Importance of MELD-Na score in predicting postoperative complications in patients with gastric cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients undergoing gastrectomy due to gastric cancer
Exclusion Criteria:
  • Patients with pulmonary, hepatic and renal disfunctions,

  • Patients with diagnosed with a different cancer in the last 5 years and

  • Pregnant patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Training and Research Hospital Istanbul Turkey 34029

Sponsors and Collaborators

  • Istanbul Training and Research Hospital

Investigators

  • Principal Investigator: Cihad Tatar, MD, Istanbul Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cihad Tatar, Associate Professor, Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04791293
Other Study ID Numbers:
  • 2630
First Posted:
Mar 10, 2021
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022