CompletedNot Applicable

Patient Satisfaction With Sedated vs. Unsedated Colonoscopy

Germany1,070 participantsStarted 2016-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Patient satisfaction-score (Schoen et al.)

Timeframe: within 1-2 weeks after the procedure

Trial details

NCT IDNCT02770742

SponsorHelios Research Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-03-01

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