Preoperative EvaluationNCT06810232
Effects of General Health Risk Factors on Prolonged Hospital Stay
An observational study of Preoperative Evaluation and Anesthesia, run by Naime Yalçın at 1 site in Turkey (Türkiye).
Trial summary
According to the literature, a detailed preoperative anesthesia assessment systematically verifies perioperative risks, provides functional and physiological optimization, improves the patient's condition and the perioperative process, and prevents complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Evaluation, Anesthesia, Day Surgery
- What is being tested?
- Gastrointestinal endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 580 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 1 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 who apply to our hospital's anesthesia outpatient clinic for preoperative anesthesia evaluation for gastrointestinal endoscopy.
Who may be able to join
- Being over 18 years old
- ASA I-IV status
- Undergoing surgery for gastrointestinal endoscopy
- Under sedation anesthesia
Who cannot join
- In case the procedure is performed while awake
- Emergency endoscopy
- ASA-E is required
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
Istanbul, 34000
About this study
Official title: Effects of General Health Risk Factors on Prolonged Hospital Stay in Non-operating Room Anesthesia Preoperative Anesthesia Examination; Prospective Study
According to the literature, a detailed preoperative anesthesia assessment systematically verifies perioperative risks, provides functional and physiological optimization, improves the patient's condition and the perioperative process, and prevents complications. In this context, the investigators aimed to determine the frequency of lifestyle risk factors in patients who applied to investigator's clinic for preoperative anesthesia assessment due to adult gastrointestinal endoscopy, to investigate the relationship between lifestyle risk factors and factors and outcomes during the anesthesia procedure, and to compare the effects of these risk factors on developing complications and hospital stay.
Read the detailed description
A detailed preoperative anesthesia assessment systematically validates perioperative risks, optimizes functional and physiological functions, improves patient status and perioperative process, and prevents complications. Preoperative anesthesia assessment clinics are an ideal environment to examine patients' medical conditions, ensure patient safety, and maximize economic efficiency in the preoperative period. The number of procedures performed in outpatient surgery centers has now far exceeded inpatient procedures. With an estimate that 44% of increasingly difficult adverse perioperative events are preventable, it is anticipated that perioperative complications can be reduced through anesthesia clinic examinations. In the absence of clinical examinations, surgical delays and case cancellations due to incomplete patient information will occur. In recent years, the implementation of a large number of complex surgical procedures and the planning of more complicated patients for intervention in the outpatient setting have contributed significantly to the development of day surgery. With the significant increase in the number of patients undergoing outpatient surgery, comprehensive and detailed preoperative assessment and optimization have become increasingly important in patients with multiple comorbidities and unusual conditions. Preoperative screening is essential for patients at risk who may benefit from preoperative optimization. For this purpose, close communication between the surgeon, anesthesiologist, and family physician is essential. There is no doubt that perioperative morbidity and mortality are closely related to the patient's preoperative health status, the surgical procedure performed, and the anesthesia technique used. Various studies have been conducted to confirm and quantify the relationships between risk factors and the incidence of perioperative adverse events. Perioperative factors, accompanied by preoperative risk assessment, help identify patients at increased risk and enable management strategies to reduce postoperative complications and improve patient outcomes. Anesthesia services for gastrointestinal (GI) endoscopic procedures are included in outpatient anesthesia procedures and have increased significantly in frequency over the years. Before 2004, only a fraction of endoscopic procedures were performed with anesthesia, while by 2009, 30-35% of upper endoscopy and colonoscopies were performed with anesthesia under sedation, and this number increased to half of colonoscopies in 2012. Although the use of propofol in endoscopic surgery has increased, the relationship between increased complications due to sedation remains unclear. While some studies have reported increased risk of aspiration pneumonia, colon perforation, bleeding, and cardiovascular events, other studies have shown that there is no increase in the risk of complications during this process. The primary aim of investigator's study was to determine the frequency of lifestyle risk factors in patients who applied to investigator's clinic for preoperative anesthesia evaluation due to adult gastrointestinal endoscopy. Secondarily, the investigator aimed to compare the effects of these risk factors on complications and hospital stay by investigating the relationship between lifestyle risk factors and factors and outcomes during the anesthesia procedure.
- Conditions
- Preoperative Evaluation, Anesthesia, Day Surgery, Life Style, Hospital Stay
- Being tested
- Gastrointestinal endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrointestinal endoscopyProcedure or surgery
Patients will be divided into groups according to general health risk factors detected during preoperative anesthesia evaluation (hypertension, diabetes, asthma, obesity, chronic disease, medication history, immobility, smoking, etc.) and will be evaluated in terms of age, gender, weight and height will be combined to report BMI in kg/m2, alcohol, allergy, ASA, endoscopy site, complications that may develop related to anesthesia and sedation (such as hemodynamic instability, hemoglobin desaturation, pulmonary aspiration and apnea), additional interventions, and hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| General health risk factors | Arm HT, Arm DM, Arm Asthma, Arm Obezity, Arm Immobility, Arm Smoke Receives: Procedure: Gastrointestinal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between general health risk factors and prolonged hospital stay
Investigator planned to divide patients who applied to investigator's anesthesia clinic for gastrointestinal endoscopy into groups according to their general health risk factors (hypertension, diabetes, asthma, immobility, obesity, smoking, etc.) during preoperative anesthesia evaluations, and to primarily determine the number of patients who admitted in the ward after endoscopy despite performing day-case procedures among the groups, and secondarily, to observe the frequency of endoscopy procedures for each group, as well as to examine the length of stay in the recovery unit and complications after the procedure.
Measured: Up to 8 weeks after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start2 Jan 2025
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative EvaluationStudies 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
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naime Yalçın
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naime Yalçın, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810232
- Sponsor's protocol ID
- KAEK/2024.12.276
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2025
- Last updated
- 10 Feb 2025
- 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of General Health Risk Factors on Prolonged Hospital Stay in Non-operating Room Anesthesia Preoperative Anesthesia Examination; Prospective Study
- ClinicalTrials.gov ID
- NCT06810232
- Acronym / sponsor ID
- KAEK/2024.12.276
- Conditions
- Preoperative Evaluation, Anesthesia, Day Surgery, Life Style, Hospital Stay
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Naime YalçınUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 5 Feb 2025 (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.
According to the literature, a detailed preoperative anesthesia assessment systematically verifies perioperative risks, provides functional and physiological optimization, improves the patient's condition and the perioperative process, and prevents complications. In this context, the investigators aimed to determine the frequency of lifestyle risk factors in patients who applied to investigator's clinic for preoperative anesthesia assessment due to adult gastrointestinal endoscopy, to investigate the relationship between lifestyle risk factors and factors and outcomes during the anesthesia procedure, and to compare the effects of these risk factors on developing complications and hospital stay.
Detailed description
A detailed preoperative anesthesia assessment systematically validates perioperative risks, optimizes functional and physiological functions, improves patient status and perioperative process, and prevents complications. Preoperative anesthesia assessment clinics are an ideal environment to examine patients' medical conditions, ensure patient safety, and maximize economic efficiency in the preoperative period. The number of procedures performed in outpatient surgery centers has now far exceeded inpatient procedures. With an estimate that 44% of increasingly difficult adverse perioperative events are preventable, it is anticipated that perioperative complications can be reduced through anesthesia clinic examinations. In the absence of clinical examinations, surgical delays and case cancellations due to incomplete patient information will occur. In recent years, the implementation of a large number of complex surgical procedures and the planning of more complicated patients for intervention in the outpatient setting have contributed significantly to the development of day surgery. With the significant increase in the number of patients undergoing outpatient surgery, comprehensive and detailed preoperative assessment and optimization have become increasingly important in patients with multiple comorbidities and unusual conditions. Preoperative screening is essential for patients at risk who may benefit from preoperative optimization. For this purpose, close communication between the surgeon, anesthesiologist, and family physician is essential. There is no doubt that perioperative morbidity and mortality are closely related to the patient's preoperative health status, the surgical procedure performed, and the anesthesia technique used. Various studies have been conducted to confirm and quantify the relationships between risk factors and the incidence of perioperative adverse events. Perioperative factors, accompanied by preoperative risk assessment, help identify patients at increased risk and enable management strategies to reduce postoperative complications and improve patient outcomes. Anesthesia services for gastrointestinal (GI) endoscopic procedures are included in outpatient anesthesia procedures and have increased significantly in frequency over the years. Before 2004, only a fraction of endoscopic procedures were performed with anesthesia, while by 2009, 30-35% of upper endoscopy and colonoscopies were performed with anesthesia under sedation, and this number increased to half of colonoscopies in 2012. Although the use of propofol in endoscopic surgery has increased, the relationship between increased complications due to sedation remains unclear. While some studies have reported increased risk of aspiration pneumonia, colon perforation, bleeding, and cardiovascular events, other studies have shown that there is no increase in the risk of complications during this process. The primary aim of investigator's study was to determine the frequency of lifestyle risk factors in patients who applied to investigator's clinic for preoperative anesthesia evaluation due to adult gastrointestinal endoscopy. Secondarily, the investigator aimed to compare the effects of these risk factors on complications and hospital stay by investigating the relationship between lifestyle risk factors and factors and outcomes during the anesthesia procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General health risk factors | – | Procedure: Gastrointestinal endoscopyArm HT, Arm DM, Arm Asthma, Arm Obezity, Arm Immobility, Arm Smoke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who apply to our hospital's anesthesia outpatient clinic for preoperative anesthesia evaluation for gastrointestinal endoscopy.
Key inclusion criteria (4 listed)
- Being over 18 years old
- ASA I-IV status
- Undergoing surgery for gastrointestinal endoscopy
- Under sedation anesthesia
Key exclusion criteria (3 listed)
- In case the procedure is performed while awake
- Emergency endoscopy
- ASA-E is required
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 |
|---|---|---|
| Gastrointestinal endoscopyPatients will be divided into groups according to general health risk factors detected during preoperative anesthesia evaluation (hypertension, diabetes, asthma, obesity, chronic disease, medication history, immobility, smoking, etc.) and will be evaluated in terms of age, gender, weight and height will be combined to report BMI in kg/m2, alcohol, allergy, ASA, endoscopy site, complications that may develop related to anesthesia and sedation (such as hemodynamic instability, hemoglobin desaturation, pulmonary aspiration and apnea), additional interventions, and hospital stay. | Procedure or surgery | General health risk factors |
Primary outcome
Association between general health risk factors and prolonged hospital stay
Time frame: Up to 8 weeks after registration
Investigator planned to divide patients who applied to investigator's anesthesia clinic for gastrointestinal endoscopy into groups according to their general health risk factors (hypertension, diabetes, asthma, immobility, obesity, smoking, etc.) during preoperative anesthesia evaluations, and to primarily determine the number of patients who admitted in the ward after endoscopy despite performing day-case procedures among the groups, and secondarily, to observe the frequency of endoscopy procedures for each group, as well as to examine the length of stay in the recovery unit and complications after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Preoperative Evaluation and Anesthesia, run by Naime Yalçın 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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 10 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Association between general health risk factors and prolonged hospital stay (time frame: Up to 8 weeks after registration). 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 10 Feb 2025.