NCT02770742

Patient Satisfaction With Sedated vs. Unsedated Colonoscopy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,070 (actual)
• Sponsor: Helios Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Satisfaction

Timeline

• Start date: 2016-10-01
• Primary completion: 2020-03-01
• Completion: 2020-09-03
• First posted: 2016-05-12
• Last updated: 2022-03-22

Locations

1 site across 1 country: Germany