NCT06810232

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
580

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2025

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

January 27, 2025

Last Update Submit

February 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 8 weeks after registration

Study Arms (1)

General health risk factors

Arm HT, Arm DM, Arm Asthma, Arm Obezity, Arm Immobility, Arm Smoke

Procedure: Gastrointestinal endoscopy

Interventions

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.

General health risk factors

Eligibility Criteria

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

Patients who apply to our hospital's anesthesia outpatient clinic for preoperative anesthesia evaluation for gastrointestinal endoscopy.

You may qualify if:

  • Being over 18 years old
  • ASA I-IV status
  • Undergoing surgery for gastrointestinal endoscopy
  • Under sedation anesthesia

You may not qualify if:

  • In case the procedure is performed while awake
  • Emergency endoscopy
  • ASA-E is required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Endoscopy, Gastrointestinal

Intervention Hierarchy (Ancestors)

Endoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist Anesthesiology and Reanimation

Study Record Dates

First Submitted

January 27, 2025

First Posted

February 5, 2025

Study Start

January 2, 2025

Primary Completion

April 1, 2025

Study Completion

July 1, 2025

Last Updated

February 10, 2025

Record last verified: 2025-02

Locations