Reduction of Pain in Colonoscopy - Loop First Versus Last

Colonoscopy is an endoscopic examination of the colon. Colonoscopy is used to investigate medical gastroenterological diseases, as well as to investigate suspected cancer and to prevent it by identifying and removing premalignant changes - polyps (e.g., as part of the national screening program for colorectal cancer).

As part of a normal endoscopic examination, the tip of the endoscope is bent (retroflexed) to look "backward" into the rectum. This is done to better see the inside of the rectal opening. Performing such a retroflexion of the scope is often associated with discomfort/pain for the patient. It takes 5-10 seconds. There are no guidelines on when such a retroflexion should be done - at the beginning or at the end of the procedure. The aim is to investigate whether the timing of retroflexion makes a difference in the recollection of pain following the procedure. In this way, the pain of colonoscopy might be reduced in the future simply by changing the timing of the retroflexion.

The study is solely about performing this retroflexion either at the beginning or at the end of the examination. Nothing is changed in the diagnostic part of the examination.

The background of the study is a study from 2003 that shows that taking about a one-minute pause in the rectum at the end of the colonoscopy can reduce the overall pain perception of the examination. This was shown without changing the pain during the procedure and despite the fact that the examination itself was prolonged due to the intervention. This relationship is explained by studies showing that the pain experience at the end of a procedure has a greater influence than the pain experience at the beginning of a procedure on the overall pain experience.

Hypothesis: By retroflexing in the rectum first during a colonoscopy versus at the end, patients will perceive the overall procedure as less painful.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: Timing of retroflexion

• Study Type: Interventional
• Enrollment (Actual): 1120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Hospital Sønderjylland
  • Esbjerg, Denmark, 6700
    • Esbjerg Hospital, University Hospital of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients scheduled for elective diagnostic colonoscopy at the surgical department

Exclusion Criteria:

• age <18
• pregnancy
• colonoscopy under general anæsthesia
• patients not fluent in danish
• patients uanable to understand the study (e.g. people with diagnosed or suspected dementia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: loop first; Those will have the retroflexion/looping of the colonoscope performed as the first part of the colonoscopy
Experimental: loop last; Those will have the retroflexion/looping of the colonoscope performed as the last part of the colonoscopy	Procedure: Timing of retroflexion; The intervention is the timing of the retroflexion/looping of the colonoscope in the rectum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remembrance of pain	Visual Analogue Pain (VAS) score of pain. The score is from 0-100 where a smaller score means less pain.	15-60 minutes post colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal pain	A simple question on which part of the investigation is remembered as the most painful and how this is rated on a Visual Analogue Pain (VAS) scale. The VAS scale goes from 0-100 where a smaller score means less pains	15-60 minutes post colonoscopy

Collaborators and Investigators

• Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 24/27699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No