Gastrointestinal TumoursNCT05583292
Mortality Predictions With Scorring Indices in Gastrointestinal Tumours
An observational study of Gastrointestinal Tumours, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Tumours
- What is being tested?
- ASA-PS, SORT and Sarcopenia
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2023to 15 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing gastrointestinal tumor surgery in a tertiary madical center
Who may be able to join
- >18 years of age
- operation for gastrointestinal tumors
Who cannot join
- patient rejection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul
About this study
Official title: The Effectiveness of ASA, SORT and Sarcopenia Indices in Estimating Mortality and Morbidity in Gastrointestinal Tumour Surgery
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.
Read the 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.
- Conditions
- Gastrointestinal Tumours
- Being tested
- ASA-PS, SORT, Sarcopenia
- Keywords
- ASA-PS, SORT, Sarcopenia, Mortality, Morbidity
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of mortality
death depending on the operation
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start11 Feb 2023
- Primary completion30 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fethi Gultop, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- fethi gültop, MD, Principal investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583292
- Sponsor's protocol ID
- 01f
- Status last verified
- Dec 2024
- First submitted
- 13 Oct 2022
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of ASA, SORT and Sarcopenia Indices in Estimating Mortality and Morbidity in Gastrointestinal Tumour Surgery
- ClinicalTrials.gov ID
- NCT05583292
- Acronym / sponsor ID
- 01f
- Conditions
- Gastrointestinal Tumours
- Keywords
- ASA-PS, SORT, Sarcopenia, Mortality, Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 11 Feb 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing gastrointestinal tumor surgery in a tertiary madical center
Key inclusion criteria (2 listed)
- >18 years of age
- operation for gastrointestinal tumors
Key exclusion criteria (1 listed)
- patient rejection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASA-PSThe American Society of Anesthesiologists classification of physical status (ASA PS) is a scale consisting of 6 classes showing the preoperative comorbidity of the patient. | Other | – |
| SORTSurgical outcome risk tool (SORT) is a scale used to estimate patient preoperative mortality/ morbidity, measured from sortsurgery.com. | Other | – |
| SarcopeniaSarcopenia 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 | Other | – |
Primary outcome
rate of mortality
Time frame: 6 months after surgery
death depending on the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fethi gültop, MD principal investigator
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Tumours, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of mortality (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.