Clinical trial NCT02770742: Patient Satisfaction With Sedated vs. Unsedated Colonoscopy
Official title: Patient Satisfaction With Sedated vs. Unsedated Colonoscopy - Which Factors Affect Satisfaction and Pain in Routine Care?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Satisfaction
Keywords: patient satisfaction
unsedated colonoscopy
intestinal diseases
Lead sponsor: Helios Research Center
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 1070
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients, presenting for outpatient colonoscopy.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Patient satisfaction-score (Schoen et al.)
timeFrame: within 1-2 weeks after the procedure
Secondary outcomes:
measure: NAPCOMS score
timeFrame: within the procedure and modified 1-2 weeks after the procedure.
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: DKD Helios Klinik Wiesbaden
state: Hesse
Study officials:
affiliation: DKD Helios Klinik Wiesbaden, Germany
name: Alexander J Eckardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eckardt VF, Kanzler G, Schmitt T, Eckardt AJ, Bernhard G. Complications and adverse effects of colonoscopy with selective sedation. Gastrointest Endosc. 1999 May;49(5):560-5. doi: 10.1016/s0016-5107(99)70382-2.
citation: Petrini JL, Egan JV, Hahn WV. Unsedated colonoscopy: patient characteristics and satisfaction in a community-based endoscopy unit. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):567-72. doi: 10.1016/j.gie.2008.10.027.
citation: Eckardt AJ, Swales C, Bhattacharya K, Wassef WY, Phelan NP, Zubair S, Martins N, Patel S, Moquin B, Anwar N, Leung K, Levey JM. Open access colonoscopy in the training setting: which factors affect patient satisfaction and pain? Endoscopy. 2008 Feb;40(2):98-105. doi: 10.1055/s-2007-995469.
citation: Cockburn J, Hill D, Irwig L, De Luise T, Turnbull D, Schofield P. Development and validation of an instrument to measure satisfaction of participants at breast screening programmes. Eur J Cancer. 1991;27(7):827-31. doi: 10.1016/0277-5379(91)90126-x.
citation: Schoen RE, Weissfeld JL, Baum A. Development of a simple instrument to measure patient satisfaction with flexible sigmoidoscopy. Gastroenterology 1995; 108: A34