Patient Satisfaction With Sedated vs. Unsedated Colonoscopy

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.

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Key information

Conditions

Satisfaction Behavior Digestive System Diseases Gastrointestinal Diseases Health Behavior Intestinal Diseases Patient Satisfaction Personal Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DKD Helios Klinik Wiesbaden

Wiesbaden, Hesse, 65191, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Patient satisfaction-score (Schoen et al.)

Time frame: within 1-2 weeks after the procedure

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.

Secondary outcomes

NAPCOMS score

Time frame: within the procedure and modified 1-2 weeks after the procedure.

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.

Sponsors and collaborators

Lead sponsor

Helios Research Center

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: May 12, 2016
Registry last updated: Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed