Patient Satisfaction With Sedated vs. Unsedated Colonoscopy

• Register: ClinicalTrials.gov
• Last refreshed on: 28 March 2022
• Main ID: NCT02770742
• Date of registration: 10/05/2016
• Prospective Registration: Yes
• Primary sponsor: Helios Research Center
• Public title: Patient Satisfaction With Sedated vs. Unsedated Colonoscopy
• Scientific title: Patient Satisfaction With Sedated vs. Unsedated Colonoscopy - Which Factors Affect Satisfaction and Pain in Routine Care?
• Date of first enrolment: October 2016
• Target sample size: 1070
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02770742
• Study type: Observational

Countries of recruitment

Germany

Contacts

• Name: Alexander J Eckardt, MD
• Affiliation: DKD Helios Klinik Wiesbaden, Germany

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Satisfaction

Primary Outcome(s)

Patient satisfaction-score (Schoen et al.) [Time Frame: within 1-2 weeks after the procedure]

Secondary Outcome(s)

NAPCOMS score [Time Frame: within the procedure and modified 1-2 weeks after the procedure.]

Secondary ID(s)

HRC[058465]

Source(s) of Monetary Support

Please refer to primary and secondary sponsors