Study of Frailty and Its Impact on Outpatient Digestive Endoscopy in Patients Over 70
Led by Parc de Salut Mar · Updated on 2025-07-31
1474
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting a prospective observational study to understand frailty in patients over 70 years old undergoing outpatient digestive endoscopy. The study aims to determine how common frailty is, how severe it is, and how it affects the success and safety of endoscopic procedures. This research will help create care protocols to improve outcomes and reduce complications in frail patients during endoscopy.
Participants are patients aged over 70 who are referred for either upper or lower digestive endoscopy. Frailty will be assessed using validated questionnaires via telephone interviews conducted by trained nurses. Data on patient demographics, comorbidities, frailty scores, endoscopy preparation, and procedure details will be collected. The study will track complications during and after endoscopy, as well as the effectiveness and cost of the procedures.
Throughout the study, participants will be monitored for relevant adverse events requiring medical attention up to 30 days after their endoscopy. Information about preparation quality, procedure complications, and clinical impact will be gathered from medical records. Researchers will analyze how frailty relates to these outcomes, helping to identify ways to improve care for older, frail patients undergoing digestive endoscopy.
CONDITIONS
Brief Title
Frailty in Outpatient Digestive Endoscopy
Research Team
A
AGUSTIN SEOANE URGORRI, MD
D
DIEGO E LARREA LEIVA, MD
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Scheduled for ambulatory upper or lower digestive endoscopy
Able to participate in telephone questionnaire assessment
Willing to provide consent for study participation
You will not qualify if you...
Age below 70 years
Undergoing non-ambulatory endoscopy
Endoscopist assessment indicating contraindications for the procedure
Declines to participate in the study
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 telephone contact (remote) to assess frailty using questionnaires
Digestive Endoscopy Procedure
Duration - Single day
Participants undergo an ambulatory upper or lower digestive endoscopy as part of routine clinical care. Information about the procedure, preparation, and any intra-procedure complications is collected.
1 in-person endoscopy visit
Post-Endoscopy Monitoring
Duration - Up to 2 months after endoscopy
Participants are monitored for relevant adverse effects and clinical outcomes following the endoscopy procedure.
Follow-up information collected through clinical records and possible medical visits as needed
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Risks, indications and technical aspects of colonoscopy in elderly or frail patients. Position paper of the Societat Catalana de Digestologia, the Societat Catalana de Geriatria i Gerontologia and the Societat Catalana de Medicina de Familia i Comunitaria.
Salvador Machlab, Esther Francia, Juanjo Mascort...