Clinical trial NCT04791293: The Model for End-Stage Liver Disease Sodium (MELD-Na) Score in Non-cirrhotic Patients With Gastric Cancer
Official title: Predictive Value of MELD-Na Score for Perioperative Complications in Non-cirrhotic Patients With Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Complication,Postoperative
Complications; Gastrointestinal, Postoperative
Morality
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-03-10
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing gastrectomy due to gastric cancer

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.


Eligibility criteria: 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

Primary outcomes:
measure: MELD-Na score difference between the groups
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
Study officials:
affiliation: Istanbul Training and Research Hospital
name: Cihad Tatar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.