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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05038917
Other study ID # SEEUPP 04545/02915
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 30, 2020
Est. completion date December 31, 2022

Study information

Verified date September 2021
Source Ostergotland County Council, Sweden
Contact Andreas Nilsson, PhD
Phone +46(0)704417975
Email andreas.nilsson@regionostergotland.se
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Endoscopic procedures for biliary strictures, stenting or drainage (ERCP) and ultrasonic imaging or biopsies (EUS) are performed under sedation or anesthesia. The main purpose of the study is to evaluate aspects of procedure treatability and patients´ quality of recovery.


Description:

The main aim of this study is to evaluate the effects on treatability and procedure failur; also aspects of post-procedure quality of recovery from patients cognitive function and from the choice of sedation/anesthesia for ERCP and EUS-procedures. Before endoscopic procedures, patients do not always read the written information sent to them. That´s a problem since patients tend to be insufficient prepared for the procedures. Therefore, evaluation of patients' health literacy was performed. Patients are sedated (patient-controlled sedation or by nurse anesthetists) or in general anesthesia. No randomisation.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (=18 years) - Patients cheduled for ERCP or/and EUS - Patients who have given their informed and written concent to participate Exclusion Criteria: Patients with - confusion - dementia - communication problems.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Sweden University hospital of Linköping Linköping Östergötland

Sponsors (1)

Lead Sponsor Collaborator
Ostergotland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dimensions of recovery recorded by Quality of Recovery 15 swedish version Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better Baseline (Day 0)
Primary Dimensions of recovery recorded by Quality of Recovery 15 swedish version Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better Day 1
Primary Dimensions of recovery recorded by Quality of Recovery 15 swedish version Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better Day 5
Secondary Health literacy measured by the use of FHL (swedish version) Health literacy (FHL swedish version), Max 0 Min 5, 0 is good, 5 is bad Before procedure (Day 0)
Secondary Aborted or increased difficulty to performed the planned procedure Procedure failure, numbers of aborted procedures and numbers of difficult performance From start of procedure to the end of it (Day 0)
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