Sedation for Endoscopic Procedures (SEEUPP)

September 8, 2021 updated by: Andreas Nilsson, Ostergotland County Council, Sweden

Sedation for Endoscopic Procedures - a Follow-up Study of Efficiency and Safety

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥18 years) scheduled for ERCP or/and EUS

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dimensions of recovery recorded by Quality of Recovery 15 swedish version
Time Frame: Baseline (Day 0)
Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better
Baseline (Day 0)
Dimensions of recovery recorded by Quality of Recovery 15 swedish version
Time Frame: Day 1
Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better
Day 1
Dimensions of recovery recorded by Quality of Recovery 15 swedish version
Time Frame: Day 5
Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better
Day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health literacy measured by the use of FHL (swedish version)
Time Frame: Before procedure (Day 0)
Health literacy (FHL swedish version), Max 0 Min 5, 0 is good, 5 is bad
Before procedure (Day 0)
Aborted or increased difficulty to performed the planned procedure
Time Frame: From start of procedure to the end of it (Day 0)
Procedure failure, numbers of aborted procedures and numbers of difficult performance
From start of procedure to the end of it (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ostergotland County Council, Sweden

Investigators

  • Study Chair: Andreas o Nilsson, PhD, Ljungsborg Haga 1

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2020

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

September 8, 2021

First Posted (Actual)

September 9, 2021

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SEEUPP 04545/02915

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No sharing plans

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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