NCT05583292

Brief Summary

The ASA-PS, SORT and Sarcopenia scores of the patients who will undergo surgery for a gastrointestinal tumor will be recorded. Thus, the correlation between preoperative indices and mortality/morbidity will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

October 13, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 11, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

October 13, 2022

Last Update Submit

December 6, 2024

Conditions

Gastrointestinal Tumours

Keywords

ASA-PSSORTSarcopeniaMortalityMorbidity

Outcome Measures

Primary Outcomes (1)

  • rate of mortality

    death depending on the operation

    6 months after surgery

Interventions

ASA-PSOTHER

The American Society of Anesthesiologists classification of physical status (ASA PS) is a scale consisting of 6 classes showing the preoperative comorbidity of the patient.

SORTOTHER

Surgical outcome risk tool (SORT) is a scale used to estimate patient preoperative mortality/ morbidity, measured from sortsurgery.com.

SarcopeniaOTHER

Sarcopenia represents a loss of muscle strength and mass in older individuals and people who have tumors. Sarcopenia score is valuable in predicting preoperative mortality/ morbidity

Eligibility Criteria

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

patients undergoing gastrointestinal tumor surgery in a tertiary madical center

You may qualify if:

  • \>18 years of age
  • operation for gastrointestinal tumors

You may not qualify if:

  • patient rejection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

4-azidosalicylic acid-phosphatidylserine

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • fethi gültop, MD

    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Anesthesiology and Reanimation Specialist, Principal Investigator, Lecturer MD

Study Record Dates

First Submitted

October 13, 2022

First Posted

October 17, 2022

Study Start

February 11, 2023

Primary Completion

July 30, 2023

Study Completion

August 15, 2023

Last Updated

December 11, 2024

Record last verified: 2024-12

Locations

TU(1)