Patient Satisfaction With Sedated vs. Unsedated Colonoscopy

NCT02770742 | Completed

• 1 other identifier: HRC[058465]
• Study Type: observational
• Target: 1,070
• Locations: 1 country
• Sites: 1

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.

Conditions

Satisfaction

Keywords

patient satisfaction; unsedated colonoscopy; intestinal diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• NAPCOMS score

  within the procedure and modified 1-2 weeks after the procedure.

Study Arms (1)

Patients for outpatient colonoscopy

The cohort consists of subsequent patients who present for routine colonoscopy. There is no active Intervention. However, groups who choose to perform colonoscopy with or without sedation will be compared.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients, presenting for outpatient colonoscopy.

You may qualify if:

• Consecutive patients presenting for colonoscopy
• Age \>18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helios Research Center: lead

Study Sites (1)

DKD Helios Klinik Wiesbaden

Wiesbaden, Hesse, 65191, Germany

Location

Related Publications (5)

• 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.

  PMID: 10228252 BACKGROUND

• 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.

  PMID: 19231501 BACKGROUND

• 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.

  PMID: 18253904 BACKGROUND

• 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.

  PMID: 1834111 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction; Patient Satisfaction; Intestinal Diseases

Condition Hierarchy (Ancestors)

Behavior; Treatment Adherence and Compliance; Health Behavior; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Alexander J Eckardt, MD

  DKD Helios Klinik Wiesbaden, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Alexander Eckardt

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 12, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: September 3, 2020
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)