Patient Satisfaction With Sedated vs. Unsedated Colonoscopy
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.
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
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.
patient satisfaction, unsedated colonoscopy, intestinal diseases
Helios Research Center
Helios Research Center
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