Actively Recruiting

Age: 70Years - 100Years
All Genders
ID06507527

Assessment of Care Adequacy in Frail Patients Undergoing Digestive Endoscopy (FRIEND Study)

Led by Parc de Salut Mar · Updated on 2025-07-31

1474

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

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

Who Can Participate

Age: 70Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 70 years or older
  • Scheduled for ambulatory upper or lower digestive endoscopy
  • Able to participate in telephone questionnaire assessment
  • Willing to provide consent for study participation
Not Eligible

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

AI-Screening

AI-Powered Screening

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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

Trial Site Locations

Total: 1 location

1

Parc de Salut Mar. Hospital del Mar

Barcelona, Spain, 08003

Actively Recruiting

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Research Team

A

AGUSTIN SEOANE URGORRI, MD

D

DIEGO E LARREA LEIVA, MD

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...

https://pubmed.ncbi.nlm.nih.gov/37209916