Reduction of Pain in Colonoscopy - Loop First Versus Last

NCT06521658 | Completed

• 1 other identifier: 24/27699
• Study Type: interventional
• Target: 1,120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Maximal pain

  15-60 minutes post colonoscopy

Study Arms (2)

loop first

NO INTERVENTION

Those will have the retroflexion/looping of the colonoscope performed as the first part of the colonoscopy

loop last

EXPERIMENTAL

Those will have the retroflexion/looping of the colonoscope performed as the last part of the colonoscopy

Procedure: Timing of retroflexion

Interventions

Timing of retroflexion PROCEDURE

The intervention is the timing of the retroflexion/looping of the colonoscope in the rectum

loop last

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for elective diagnostic colonoscopy at the surgical department

You may not qualify if:

• 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)

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead

Study Sites (2)

Hospital Sønderjylland

Aabenraa, 6200, Denmark

Location

Esbjerg Hospital, University Hospital of Southern Denmark

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the doctor and nurses performing the colonoscopy will not be masked to the intervention
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomisation

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 26, 2024
• Study Start: September 23, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)