Mortality Predictions With Scorring Indices in Gastrointe... | NCT05583292

Studies
Mortality Predictions With Scorring Indices in Gastrointestinal Tumours

NCT05583292

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Status

Completed

Last Update Posted

Dec 11, 2024Actual

Enrollment

111Actual

Phase

Not provided

Conditions

Gastrointestinal Tumours

Interventions

ASA-PS
SORT
Sarcopenia

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 11, 2023Actual

Primary Completion Date

Jul 30, 2023Actual

Completion Date

Aug 15, 2023Actual

First Submitted Date

Oct 13, 2022

First Submission Date that Met QC Criteria

Oct 13, 2022

First Posted Date

Oct 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2024

Last Update Posted Date

Dec 11, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fethi Gultop, MD, Anesthesiology and Reanimation Specialist, Principal Investigator, Lecturer MD, Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationPrincipal Investigator

Lead Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

ASA-PS values of patients who are planned to be operated due to gastrointestinal tumor will be recorded, then SORT (The Surgical Outcome Risk Tool) values will be calculated from sortsurgery.com. Sarcopenia measurements will be made by the radiologist from the abdomen CT at the L-3 level.

The pathology results of the patients will be recorded. Morbidity and mortality rates will be recorded in the short and long term.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

111Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
ASA-PS	Other	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.
SORT	Other	Surgical outcome risk tool (SORT) is a scale used to estimate patient preoperative mortality/ morbidity, measured from sortsurgery.com.
Sarcopenia	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of mortality	death depending on the operation	6 months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 years of age
operation for gastrointestinal tumors

Exclusion Criteria:

patient rejection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients undergoing gastrointestinal tumor surgery in a tertiary madical center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
fethi gültop, MD	Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof. Dr. Cemil Taşcıoğlu City Hospital		Istanbul			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D055948	Sarcopenia

Ancestor Terms

ID	Term
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C070385	4-azidosalicylic acid-phosphatidylserine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided