NCT04791293

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1.7 years

First QC Date

March 6, 2021

Last Update Submit

August 5, 2022

Conditions

Gastric CancerComplication,PostoperativeComplications; Gastrointestinal, PostoperativeMorality

Outcome Measures

Primary Outcomes (1)

  • MELD-Na score difference between the groups

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

    30 days

Study Arms (2)

Group 1

Patients with postoperative complications

Other: MELD-Na score

Group 2

Patients without postoperative complications

Other: MELD-Na score

Interventions

MELD-Na scoreOTHER

MELD-Na scores will be compared between the groups

Group 1Group 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing gastrectomy due to gastric cancer

You may qualify if:

  • Patients undergoing gastrectomy due to gastric cancer

You may not qualify if:

  • Patients with pulmonary, hepatic and renal disfunctions,
  • Patients with diagnosed with a different cancer in the last 5 years and
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34029, Turkey (Türkiye)

Location

Related Publications (3)

  • Coakley KM, Sarasani S, Prasad T, Steele SR, Paquette I, Heniford BT, Davis BR. MELD-Na Score as a Predictor of Anastomotic Leak in Elective Colorectal Surgery. J Surg Res. 2018 Dec;232:43-48. doi: 10.1016/j.jss.2018.04.012. Epub 2018 Jul 2.

    PMID: 30463752BACKGROUND

  • Schlosser KA, Kao AM, Zhang Y, Prasad T, Kasten KR, Davis BR, Heniford BT, Colavita PD. MELD-Na score associated with postoperative complications in hernia repair in non-cirrhotic patients. Hernia. 2019 Feb;23(1):51-59. doi: 10.1007/s10029-018-1849-2. Epub 2018 Nov 16.

    PMID: 30446849BACKGROUND

  • Yasri S, Wiwanitkit V. MELD-Na score and postoperative complications in hernia repair. Hernia. 2019 Aug;23(4):823. doi: 10.1007/s10029-019-01886-z. Epub 2019 Jan 22. No abstract available.

    PMID: 30671898BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsPostoperative Complications

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cihad Tatar, MD

    Istanbul Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 6, 2021

First Posted

March 10, 2021

Study Start

December 1, 2020

Primary Completion

August 5, 2022

Study Completion

August 5, 2022

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations

TU(1)