SatisfactionNCT02770742
Patient Satisfaction With Sedated vs. Unsedated Colonoscopy
An observational study of Satisfaction, run by Helios Research Center at 1 site in Germany.
Trial summary
This is a prospective, observational study to evaluate patient satisfaction with colonoscopy, depending on whether sedation is used during the procedure or not. Patients will receive questionnaires before the procedure to assess the potential influence of patient criteria and after the procedure to assess… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Satisfaction
- How many people
- 1,070 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2016to 3 Sep 2020
- 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: Consecutive patients, presenting for outpatient colonoscopy.
Who may be able to join
- Consecutive patients presenting for colonoscopy
- Age >18 years
Who cannot join
- Patients not giving written consent
- Colonic stenosis or suspected Stenosis
- Active inflammatory bowel disease
- Previous partial resection of the colon
- Polyposis syndromes
- Inability to speak German or fill out a questionnaire in German language
- Vulnerable patients (prisoners, pregnant women, patients with mental retardation, which would affect filling out a questionnaire or answering questions)
- American Society of Anesthesiology (ASA) grade > III.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction With Sedated vs. Unsedated Colonoscopy - Which Factors Affect Satisfaction and Pain in Routine Care?
This is a prospective, observational study to evaluate patient satisfaction with colonoscopy, depending on whether sedation is used during the procedure or not. Patients will receive questionnaires before the procedure to assess the potential influence of patient criteria and after the procedure to assess satisfaction-scores and pain-scores. A validated satisfaction score (Schoen et al.) will be used for the primary outcome. As secondary parameters, pain- and sedation-scores will be assessed by the validated NAPCOMS score, as well as procedural quality indicators. The study will assess, whether adequate selection in regards to risk factors for sedated or unsedated colonoscopy, leads to similar satisfaction-scores within both groups.
Read the detailed description
This is a prospective, observational study of consecutive patients presenting for outpatient colonoscopy in a tertiary care hospital with a large ambulatory care section (DKD Helios Klinik Wiesbaden). The primary endpoint of the study is the comparison of a validated patient satisfaction score in patients undergoing colonoscopy with or without sedation. The aim is to assess whether patients, who are deemed appropriate for an unsedated procedure by predefined risk factors and who wish to avoid sedation, will have similar satisfaction scores, as those who undergo sedation. As secondary aims, pain scores (validated NAPCOMS score) and markers of procedural quality (such as completion rates or withdrawal times) will be assessed.
Considering a 2-point difference in the 15-point satisfaction score as clinically relevant and suspecting a 7:3 distribution of procedures with and without sedation, respectively, 1070 patients must be included (at least 749 sedated and 321 unsedated) in order to reach a significance level of 0.05.
- Conditions
- Satisfaction
- Keywords
- patient satisfaction, unsedated colonoscopy, intestinal diseases
- Medical subject headings
- Personal Satisfaction, Patient Satisfaction, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients for outpatient colonoscopy | The cohort consists of subsequent patients who present for routine colonoscopy. There is no active Intervention. However, groups who choose to perform colonoscopy with or without sedation will be compared. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction-score (Schoen et al.)
The satisfaction score is based on the following three statements: (a) "I was very satisfied with the care I received"; (b) "I would strongly recommend this procedure to friends who qualify for it"; (c) "I would be willing to repeat the exam in the future if necessary." Each statement is coded on a 5-point ordinate scale that includes the following choices: strongly agree, agree, not sure, disagree and strongly disagree. The average of the scores for the three statements will be used as the satisfaction score.
Measured: within 1-2 weeks after the procedure
Secondary outcomes (1)
NAPCOMS score
The NAPCOMS was designed to be completed by the endoscopy nurse assisting during the procedure. It is a composite measure that includes 3 domains: pain, sedation, and a global subjective assessment of tolerability.
The pain domain is defined by using the dimensions of intensity, frequency, and duration, which are each rated with a score from 0 (no occurrence) to 3 (severe, frequent, or prolonged). Sedation is rated according to level of consciousness ranging from 0 (wide awake) to 3 (unconscious), whereas the global tolerability score is rated from 0 (very well tolerated) to 3 (poorly tolerated). The Overall NAPCOMS was defined as the sum of the severity, frequency, and duration of pain domains. Level of sedation and overall global tolerability ratings are assessed separately.
Measured: within the procedure and modified 1-2 weeks after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startOct 2016
- Primary completion1 Mar 2020
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SatisfactionStudies 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
- 1,070 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Eckardt, MD, Helios Research Center
- Investigators
- Alexander J Eckardt, MD, Principal investigator, DKD Helios Klinik Wiesbaden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770742
- Sponsor's protocol ID
- HRC[058465]
- Status last verified
- Mar 2022
- First submitted
- 10 May 2016
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Eckardt VF, Kanzler G, Schmitt T, Eckardt AJ, Bernhard G. Complications and adverse effects of colonoscopy with selective sedation. Gastrointest Endosc. 1999 May;49(5):560-5. doi: 10.1016/s0016-5107(99)70382-2.
PubMed 10228252Petrini JL, Egan JV, Hahn WV. Unsedated colonoscopy: patient characteristics and satisfaction in a community-based endoscopy unit. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):567-72. doi: 10.1016/j.gie.2008.10.027.
PubMed 19231501Eckardt AJ, Swales C, Bhattacharya K, Wassef WY, Phelan NP, Zubair S, Martins N, Patel S, Moquin B, Anwar N, Leung K, Levey JM. Open access colonoscopy in the training setting: which factors affect patient satisfaction and pain? Endoscopy. 2008 Feb;40(2):98-105. doi: 10.1055/s-2007-995469.
PubMed 18253904Cockburn J, Hill D, Irwig L, De Luise T, Turnbull D, Schofield P. Development and validation of an instrument to measure satisfaction of participants at breast screening programmes. Eur J Cancer. 1991;27(7):827-31. doi: 10.1016/0277-5379(91)90126-x.
PubMed 1834111Schoen RE, Weissfeld JL, Baum A. Development of a simple instrument to measure patient satisfaction with flexible sigmoidoscopy. Gastroenterology 1995; 108: A34
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Sedated vs. Unsedated Colonoscopy - Which Factors Affect Satisfaction and Pain in Routine Care?
- ClinicalTrials.gov ID
- NCT02770742
- Acronym / sponsor ID
- HRC[058465]
- Conditions
- Satisfaction
- Keywords
- patient satisfaction, unsedated colonoscopy, intestinal diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,070 participants (actual)
- Lead sponsor
- Helios Research CenterUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 12 May 2016 (estimated)
- 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 is a prospective, observational study to evaluate patient satisfaction with colonoscopy, depending on whether sedation is used during the procedure or not. Patients will receive questionnaires before the procedure to assess the potential influence of patient criteria and after the procedure to assess satisfaction-scores and pain-scores. A validated satisfaction score (Schoen et al.) will be used for the primary outcome. As secondary parameters, pain- and sedation-scores will be assessed by the validated NAPCOMS score, as well as procedural quality indicators. The study will assess, whether adequate selection in regards to risk factors for sedated or unsedated colonoscopy, leads to similar satisfaction-scores within both groups.
Detailed description
This is a prospective, observational study of consecutive patients presenting for outpatient colonoscopy in a tertiary care hospital with a large ambulatory care section (DKD Helios Klinik Wiesbaden). The primary endpoint of the study is the comparison of a validated patient satisfaction score in patients undergoing colonoscopy with or without sedation. The aim is to assess whether patients, who are deemed appropriate for an unsedated procedure by predefined risk factors and who wish to avoid sedation, will have similar satisfaction scores, as those who undergo sedation. As secondary aims, pain scores (validated NAPCOMS score) and markers of procedural quality (such as completion rates or withdrawal times) will be assessed.
Considering a 2-point difference in the 15-point satisfaction score as clinically relevant and suspecting a 7:3 distribution of procedures with and without sedation, respectively, 1070 patients must be included (at least 749 sedated and 321 unsedated) in order to reach a significance level of 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients for outpatient colonoscopy | – | –The cohort consists of subsequent patients who present for routine colonoscopy. There is no active Intervention. However, groups who choose to perform colonoscopy with or without sedation will be compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients, presenting for outpatient colonoscopy.
Key inclusion criteria (2 listed)
- Consecutive patients presenting for colonoscopy
- Age >18 years
Key exclusion criteria (8 listed)
- Patients not giving written consent
- Colonic stenosis or suspected Stenosis
- Active inflammatory bowel disease
- Previous partial resection of the colon
- Polyposis syndromes
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
Patient satisfaction-score (Schoen et al.)
Time frame: within 1-2 weeks after the procedure
The satisfaction score is based on the following three statements: (a) "I was very satisfied with the care I received"; (b) "I would strongly recommend this procedure to friends who qualify for it"; (c) "I would be willing to repeat the exam in the future if necessary." Each statement is coded on a 5-point ordinate scale that includes the following choices: strongly agree, agree, not sure, disagree and strongly disagree. The average of the scores for the three statements will be used as the satisfaction score.
1 secondary outcome
NAPCOMS score
Time frame: within the procedure and modified 1-2 weeks after 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 22 Mar 2022.
- Background: PubMed 10228252Eckardt VF, Kanzler G, Schmitt T, Eckardt AJ, Bernhard G. Complications and adverse effects of colonoscopy with selective sedation. Gastrointest Endosc. 1999 May;49(5):560-5. doi: 10.1016/s0016-5107(99)70382-2.
- Background: PubMed 19231501Petrini JL, Egan JV, Hahn WV. Unsedated colonoscopy: patient characteristics and satisfaction in a community-based endoscopy unit. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):567-72. doi: 10.1016/j.gie.2008.10.027.
- Background: PubMed 18253904Eckardt AJ, Swales C, Bhattacharya K, Wassef WY, Phelan NP, Zubair S, Martins N, Patel S, Moquin B, Anwar N, Leung K, Levey JM. Open access colonoscopy in the training setting: which factors affect patient satisfaction and pain? Endoscopy. 2008 Feb;40(2):98-105. doi: 10.1055/s-2007-995469.
- Background: PubMed 1834111Cockburn J, Hill D, Irwig L, De Luise T, Turnbull D, Schofield P. Development and validation of an instrument to measure satisfaction of participants at breast screening programmes. Eur J Cancer. 1991;27(7):827-31. doi: 10.1016/0277-5379(91)90126-x.
- BackgroundSchoen RE, Weissfeld JL, Baum A. Development of a simple instrument to measure patient satisfaction with flexible sigmoidoscopy. Gastroenterology 1995; 108: A34
- Individual participant dataSharing planned: No
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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.
Alexander J Eckardt, MD principal investigator
DKD Helios Klinik Wiesbaden, Germany
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 Satisfaction, run by Helios Research Center at 1 site in Germany.
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 2 inclusion and 8 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 22 Mar 2022. 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 Germany. 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?
Patient satisfaction-score (Schoen et al.) (time frame: within 1-2 weeks after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02770742, which also lists 5 linked publications.
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 22 Mar 2022.