Patient Satisfaction With Sedated vs. Unsedated Colonoscopy

Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770742
• Other study ID #: HRC[058465]
• Status: Completed
• Start date: October 2016
• Est. completion date: September 3, 2020

Study information

• Verified date: March 2022
• Source: Helios Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1070
• Est. completion date: September 3, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Satisfaction

Locations

Country	Name	City	State
Germany	DKD Helios Klinik Wiesbaden	Wiesbaden	Hesse

Sponsors (1)

Lead Sponsor	Collaborator
Helios Research Center

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View Citation

Schoen RE, Weissfeld JL, Baum A. Development of a simple instrument to measure patient satisfaction with flexible sigmoidoscopy. Gastroenterology 1995; 108: A34

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction-score (Schoen et al.)	The satisfaction score is based on the following three statements: (a) "I was very satisfied with the care I received"; (b) "I would strongly recommend this procedure to friends who qualify for it"; (c) "I would be willing to repeat the exam in the future if necessary." Each statement is coded on a 5-point ordinate scale that includes the following choices: strongly agree, agree, not sure, disagree and strongly disagree. The average of the scores for the three statements will be used as the satisfaction score.	within 1-2 weeks after the procedure
Secondary	NAPCOMS score	The NAPCOMS was designed to be completed by the endoscopy nurse assisting during the procedure. It is a composite measure that includes 3 domains: pain, sedation, and a global subjective assessment of tolerability.; The pain domain is defined by using the dimensions of intensity, frequency, and duration, which are each rated with a score from 0 (no occurrence) to 3 (severe, frequent, or prolonged). Sedation is rated according to level of consciousness ranging from 0 (wide awake) to 3 (unconscious), whereas the global tolerability score is rated from 0 (very well tolerated) to 3 (poorly tolerated). The Overall NAPCOMS was defined as the sum of the severity, frequency, and duration of pain domains. Level of sedation and overall global tolerability ratings are assessed separately.	within the procedure and modified 1-2 weeks after the procedure.