Endoscopic Surgical ProcedureSEEUPPNCT05038917
Sedation for Endoscopic Procedures
An observational study of Endoscopic Surgical Procedure, run by Ostergotland County Council, Sweden at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Surgical Procedure
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 30 Mar 2020to 31 Dec 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) scheduled for ERCP or/and EUS
Who may be able to join
- Adult patients (≥18 years)
- Patients cheduled for ERCP or/and EUS
- Patients who have given their informed and written concent to participate
Who cannot join
- Patients with
- confusion
- dementia
- communication problems.
Trial locations and contacts
1 site in 1 country.
Sara Lyckner, PhD-stud contact
Sweden1 site, 1 recruiting
- Recruiting
University hospital of Linköping
Linköping, Östergötland County, 58183
Andreas Nilsson, PhD, +46(0)704417975, andreas.nilsson@regionostergotland.se
Sara Lyckner, PhD-stud, sara.lyckner@regionsormland.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Endoscopic Surgical Procedure
- Keywords
- Quality of recovery, Health Literacy, Moderate sedation, Deep sedation, Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (Day 0)
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
Measured: Day 1
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
Measured: Day 5
Secondary outcomes (2)
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
Measured: Before procedure (Day 0)
Aborted or increased difficulty to performed the planned procedure
Procedure failure, numbers of aborted procedures and numbers of difficult performance
Measured: From start of procedure to the end of it (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start30 Mar 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ostergotland County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Nilsson, Ostergotland County Council, Sweden
- Investigators
- Andreas o Nilsson, PhD, Study chair, Ljungsborg Haga 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038917
- Sponsor's protocol ID
- SEEUPP 04545/02915
- Acronym
- SEEUPP
- Status last verified
- Sep 2021
- First submitted
- 26 May 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing plans
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation for Endoscopic Procedures - a Follow-up Study of Efficiency and Safety
- ClinicalTrials.gov ID
- NCT05038917
- Acronym / sponsor ID
- SEEUPP / SEEUPP 04545/02915
- Conditions
- Endoscopic Surgical Procedure
- Keywords
- Quality of recovery, Health Literacy, Moderate sedation, Deep sedation, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ostergotland County Council, SwedenUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) scheduled for ERCP or/and EUS
Key inclusion criteria (3 listed)
- Adult patients (≥18 years)
- Patients cheduled for ERCP or/and EUS
- Patients who have given their informed and written concent to participate
Key exclusion criteria (4 listed)
- Patients with
- confusion
- dementia
- communication problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
2 secondary outcomes
Health literacy measured by the use of FHL (swedish version)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: No. No sharing plans
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Lyckner, PhD-stud contact
Andreas o Nilsson, PhD study chair
Ljungsborg Haga 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Surgical Procedure, run by Ostergotland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Nilsson, PhD (+46(0)704417975, andreas.nilsson@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dimensions of recovery recorded by Quality of Recovery 15 swedish version (time frame: Baseline (Day 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.