Patient Satisfaction With Sedated vs. Unsedated Colonoscopy

Helios Research Center

Status: Completed

Conditions: Satisfaction

Study type: Observational

Funder types: Other

Identifiers

NCT02770742

HRC[058465]

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,070 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,070 participants in 1 patient group

Patients for outpatient colonoscopy

Description:

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.