Frailty in Outpatient Digestive Endoscopy

NCT06507527 | Recruiting

• 1 other identifier: FRIEND
• Study Type: observational
• Target: 1,474
• Locations: 1 country
• Sites: 1

Brief Summary

The increase in our society of the proportion of frail people who suffer from disability and dependency forces us to detect modifiable factors and therefore subject to intervention that can adapt health care for frail patients in order to increase the effectiveness and safety of medical treatments and procedures. A geriatric assessment should be performed on all patients likely to present frailty prior to a digestive endoscopy to assess the risk-benefit of the indication and to improve patient preparation by avoiding adverse effects of endoscopic examinations, increasing the safety and profitability of the tests There are no data in our medium on the prevalence of frailty in patients referred for endoscopy, nor on the incidence in these patients of adverse effects, inadequate preparations, or incomplete examinations, so a frailty study is needed to elaborate multidisciplinary protocols that improve circuits and care in these patients and prevent complications. The questions we want to try to answer are:

• Prevalence and severity of fragility in digestive endoscopy.
• Specific problems related to fragility in digestive endoscopy, mainly the profitability of the examination and the incidence of adverse effects, in order to create protocols for improving care in this group of patients.

Conditions

Frailty; Comorbidities and Coexisting Conditions; Complication

Keywords

Endoscopy; Indication; Bowell Preparation; Adverse effects

Outcome Measures

Primary Outcomes (1)

• Prevalence of frailty

  Valuated frailty questionnaires (CFS and FRAGIL-VIG). Frailty is defined as a CFS rating greater than 4 or a FRAGIL-VIG value greater than 0. The degree of frailty is determined by FRAGIL-VIG score. The frailty questionnaires are completed during nurse telephone contact with the patient, prior to the digestive endoscopy.

  At the moment of telephone contact with the patient

Secondary Outcomes (5)

• Profitability of the endoscopy indication.

  At the moment of endoscopy.

• Cost of the endoscopy indication

  At the moment of endoscopy

• Incidence of relevant complications during the endoscopy process.

  30 days after digestive endoscopy.

• Clinical impact of the endoscopy indication

  Up to 2 months after endoscopy

• Degree of frailty

  At the moment of telephone contact with the patient

Study Arms (1)

Outpatients over 70 years of age referred to the Digestive Endoscopy Unit

Collection of variables: demographic variables, comorbidity, frailty (specific questionnaires), digestive endoscopy (upper and/or lower), possible complications related to the endoscopic process and the profitability and impact of the endoscopy.

Other: Collection of variables

Interventions

Collection of variables OTHER

This is an observational study, so no interventions that are not routine clinical practice are performed. It is only about collecting information on variables that are already collected in normal clinical practice.

Outpatients over 70 years of age referred to the Digestive Endoscopy Unit

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatients may be referred from hospital consultations or from out-of-hospital medical centers. Age is the inclusion criterion so that frailty can be assessed in patients over 70 years of age, who are the patients with the highest risk of presenting a frailty condition.

You may qualify if:

• It will include all patients over 70 years of age who are indicated to undergo an ambulatory upper or lower endoscopy.

You may not qualify if:

• Age below 70 years
• Non-ambulatory endoscopies
• Assessment of test contraindications by the endoscopist
• Non-acceptance to enter the study

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Parc de Salut Mar. Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Related Publications (4)

• Machlab S, Francia E, Mascort J, Garcia-Iglesias P, Mendive JM, Riba F, Guarner-Argente C, Solanes M, Ortiz J, Calvet X. 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. Gastroenterol Hepatol. 2024 Jan;47(1):107-117. doi: 10.1016/j.gastrohep.2023.05.004. Epub 2023 May 18. English, Spanish.

  PMID: 37209916 BACKGROUND

• Oberndorfer T, Jurawan R. Frailty should be assessed in older patients considered for colonoscopy. N Z Med J. 2021 Jul 30;134(1539):74-76. No abstract available.

  PMID: 34320617 BACKGROUND

• Cha JM, Kozarek RA, La Selva D, Gluck M, Ross A, Chiorean M, Koch J, Lin OS. Risks and Benefits of Colonoscopy in Patients 90 Years or Older, Compared With Younger Patients. Clin Gastroenterol Hepatol. 2016 Jan;14(1):80-6.e1. doi: 10.1016/j.cgh.2015.06.036. Epub 2015 Jul 9.

  PMID: 26164224 BACKGROUND

• Taleban S, Toosizadeh N, Junna S, Golden T, Ghazala S, Wadeea R, Tirambulo C, Mohler J. Frailty Assessment Predicts Acute Outcomes in Patients Undergoing Screening Colonoscopy. Dig Dis Sci. 2018 Dec;63(12):3272-3280. doi: 10.1007/s10620-018-5129-x. Epub 2018 May 24.

  PMID: 29796910 BACKGROUND

Related Links

• World report on aging and health. \[Internet\]. Geneva: World Health Organization.2015
• Population Projections 2018 \[Internet\]. Statistics National Institute; 2018

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• AGUSTIN SEOANE URGORRI, MD

  Parc de Salut Mar. Hospital del Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AGUSTIN SEOANE URGORRI, MD

CONTACT

932403057; aseoane@psmar.cat

DIEGO E LARREA LEIVA, MD

CONTACT

932485004; dlarrea@psmar.cat

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 18, 2024
• Study Start: June 10, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Once patient recruitment is completed, the statistician will have the study data available for as long as he or she considers appropriate to perform the analyses. The time required until the study is accepted for publication is considered appropriate.
• Access Criteria: The statistician will have access to the entire study database for the relevant statistical analyses.

Locations

ES (1)