Patient SatisfactionNCT05842720
Consented Unsedated Endoscopy in High Risk Patients That Require Anesthesiologist Observation During the Procedure
A study testing un-sedated colonoscopies in people with Patient Satisfaction, run by Sheba Medical Center at 1 site in Israel.
Trial summary
This study aim to examine the safety and feasibility of unsedated colonoscopy in patients with high risk for sedation (ASA score≥3). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- un-sedated colonoscopies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2021to 1 Sep 2022
- Phase
- Interventional
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Only adults (>18 years of age) that will be assessed as high risk and require an anesthesiologist clinic assessment prior to the procedure and anesthesiologist presence during the procedure.
Who cannot join
- Patients that are planned to go through both gastroscopy and colonoscopy procedures.
- Patients with known adhesions and/or prior small bowel obstructions.
- Patients that are planned to have a complicated procedure (complicated polypectomy etc).
- Patients that are not able to give their consent with a full understanding of the procedure.
- Patients that are pregnant.
- Patients with a heart rate above 120 bpm or less than 40 bpm at the baseline as measured before starting the procedure.
- Patients with a systolic blood pressure above 180mmHg or bellow 90mmHg as measured at the baseline before starting the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consented Unsedated Endoscopy in High Risk Patients That Require Anesthesiologist Observation During the Procedure.
This study aim to examine the safety and feasibility of unsedated colonoscopy in patients with high risk for sedation (ASA score≥3).
Read the detailed description
This was a two-part study: Part 1 was a retrospective study of patients with ASA score≥3 that underwent unsedated colonoscopy from May 2021 to August 2022 at Sheba medical center, who were contacted up to one year after the procedure and were asked to assess their satisfaction and pain level on a standard Likert score from 1-5. Part 2 was a prospective study which included high risk patients who were scheduled for an anesthesiologist-assisted sedated-colonoscopy and who consented to undergo an unsedated procedure. The primary outcome was patients' satisfaction during and up to one week after the procedure. Pain level, adverse events and hemodynamic parameters during the procedure were secondary outcomes. Baseline State-Trait Anxiety Inventory (STAI) questionnaire were also administered and results examined vis-à-vis satisfaction scores
- Conditions
- Patient Satisfaction
- Being tested
- un-sedated colonoscopies
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
un-sedated colonoscopiesProcedure or surgery
un-sedated colonoscopies in high risk patients with ASA>=3
| Study group | Role | What they receive |
|---|---|---|
| retrospective | Active comparator | Consecutive patients with ASA score≥3 that underwent unsedated colonoscopy from May 2021 to August 2022 at Sheba medical center were identified by search of the computerized endoscopy database). Following an informed consent, patients were interviewed over the phone using a structured questionnaire. To assess their satisfaction, a standard Likert scale between 1 (unsatisfied) to 5 (very satisfied) was administered. Additional assessment included the maximum level of pain experienced at any point during the procedure (between 1-no pain) to 5-severe pain), and whether they would choose to perform future procedures without sedation in the future. Patients were also asked if they were able to return on the same day to their routine daily function and activities Receives: Procedure: un-sedated colonoscopies |
| prospective | Active comparator | High risk patients scheduled for an anesthesiologist-assisted sedated-colonoscopy in Sheba medical center, were contacted during their clinic visit or by phone to receive explanation about the option to enroll in this unsedated colonoscopy study.
After obtaining informed consent, patients' Anxiety trait was assessed with the help of State-Trait Anxiety Inventory (STAI) questionnaire [8] in order to assess their level of anxiety and to investigate its predictive utility for their success in undergoing the unsedated procedure. Upon completion of the procedure in the same satisfaction questionnaire was administered, as detailed above for the retrospective part Receives: Procedure: un-sedated colonoscopies |
What is being measured
The primary outcome is the main question the study is designed to answer.
satisfaction rate
Overall satisfaction score as assessed by Likert scale post-procedure
Measured: up to 1 week after the date of the procedure
Secondary outcomes (3)
Recovery time after the procedure
the time lapse between extraction of colonoscope from the rectum and discharge of the patient from the Endoscopy recovery unit.
Measured: up to 24 hours after the procedure
Complications or adverse effects rates during the procedure
perforations, post-polypectomy bleeding, bradycardia (defined as pulse rate under 40 bpm), low oxygen saturation (defined as saturation below 90% under nasal oxygen cannula) or hemodynamically instability (defined as systolic blood pressure below 90mmHg and diastolic blood pressure below 60mmHg)
Measured: from the beginning of the procedure until the end of the procedure
Complete examination rates
how many examination were completed up to cecum intubation without need for sedation
Measured: from the beginning of the procedure until the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 May 2021
- Primary completion31 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842720
- Sponsor's protocol ID
- SHEBA-7848-20-ML-CTIL
- Status last verified
- Mar 2023
- First submitted
- 6 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consented Unsedated Endoscopy in High Risk Patients That Require Anesthesiologist Observation During the Procedure.
- ClinicalTrials.gov ID
- NCT05842720
- Acronym / sponsor ID
- SHEBA-7848-20-ML-CTIL
- Conditions
- Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 6 May 2023 (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.
This study aim to examine the safety and feasibility of unsedated colonoscopy in patients with high risk for sedation (ASA score≥3).
Detailed description
This was a two-part study: Part 1 was a retrospective study of patients with ASA score≥3 that underwent unsedated colonoscopy from May 2021 to August 2022 at Sheba medical center, who were contacted up to one year after the procedure and were asked to assess their satisfaction and pain level on a standard Likert score from 1-5. Part 2 was a prospective study which included high risk patients who were scheduled for an anesthesiologist-assisted sedated-colonoscopy and who consented to undergo an unsedated procedure. The primary outcome was patients' satisfaction during and up to one week after the procedure. Pain level, adverse events and hemodynamic parameters during the procedure were secondary outcomes. Baseline State-Trait Anxiety Inventory (STAI) questionnaire were also administered and results examined vis-à-vis satisfaction scores
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective | Active comparator | Procedure: un-sedated colonoscopiesConsecutive patients with ASA score≥3 that underwent unsedated colonoscopy from May 2021 to August 2022 at Sheba medical center were identified by search of the computerized endoscopy database). Following an informed consent, patients were interviewed over the phone using a structured questionnaire. To assess their satisfaction, a standard Likert scale between 1 (unsatisfied) to 5 (very satisfied) was administered. Additional assessment included the maximum level of pain experienced at any point during the procedure (between 1-no pain) to 5-severe pain), and whether they would choose to perform future procedures without sedation in the future. Patients were also asked if they were able to return on the same day to their routine daily function and activities |
| prospective | Active comparator | Procedure: un-sedated colonoscopiesHigh risk patients scheduled for an anesthesiologist-assisted sedated-colonoscopy in Sheba medical center, were contacted during their clinic visit or by phone to receive explanation about the option to enroll in this unsedated colonoscopy study. After obtaining informed consent, patients' Anxiety trait was assessed with the help of State-Trait Anxiety Inventory (STAI) questionnaire [8] in order to assess their level of anxiety and to investigate its predictive utility for their success in undergoing the unsedated procedure. Upon completion of the procedure in the same satisfaction questionnaire was administered, as detailed above for the retrospective part |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Only adults (>18 years of age) that will be assessed as high risk and require an anesthesiologist clinic assessment prior to the procedure and anesthesiologist presence during the procedure.
Key exclusion criteria (7 listed)
- Patients that are planned to go through both gastroscopy and colonoscopy procedures.
- Patients with known adhesions and/or prior small bowel obstructions.
- Patients that are planned to have a complicated procedure (complicated polypectomy etc).
- Patients that are not able to give their consent with a full understanding of the procedure.
- Patients that are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| un-sedated colonoscopiesun-sedated colonoscopies in high risk patients with ASA>=3 | Procedure or surgery | prospective, retrospective |
Primary outcome
satisfaction rate
Time frame: up to 1 week after the date of the procedure
Overall satisfaction score as assessed by Likert scale post-procedure
3 secondary outcomes
Recovery time after the procedure
Time frame: up to 24 hours after the procedure
Complications or adverse effects rates during the procedure
Time frame: from the beginning of the procedure until the end of the procedure
Complete examination rates
Time frame: from the beginning of the procedure until the end of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing un-sedated colonoscopies in people with Patient Satisfaction, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 6 May 2023. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
satisfaction rate (time frame: up to 1 week after the date of the procedure). 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 6 May 2023.