Patient Satisfaction With Sedated vs. Unsedated Colonoscopy

NCT ID: NCT02770742

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1070 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-09-03

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.

Conditions

Satisfaction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helios Research Center

OTHER

Sponsor Role: lead

Responsible Party

Alexander Eckardt, MD

PD Dr. med. Alexander Eckardt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander J Eckardt, MD

Role: PRINCIPAL_INVESTIGATOR

DKD Helios Klinik Wiesbaden, Germany

Locations

DKD Helios Klinik Wiesbaden

Wiesbaden, Hesse, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 10228252 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19231501 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18253904 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1834111 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

HRC[058465]

Identifier Type: -

Identifier Source: org_study_id