Patient Satisfaction With Sedated vs. Unsedated Colonoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Patient Satisfaction With Sedated vs. Unsedated Colonoscopy - Which Factors Affect Satisfaction and Pain in Routine Care?

Conditions
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Satisfaction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients presenting for colonoscopy Age >18 years Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients for outpatient colonoscopy<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 1-2 weeks after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within the procedure and modified 1-2 weeks after the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient satisfaction, unsedated colonoscopy, intestinal diseases