Reduction of Pain in Colonoscopy - Loop First Versus Last

NCT ID: NCT06521658

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-23
• Study Completion Date: 2025-01-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

loop first

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

loop last

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

Group Type: EXPERIMENTAL

Timing of retroflexion

Intervention Type: PROCEDURE

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

Interventions

Timing of retroflexion

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

Intervention Type: PROCEDURE

Eligibility Criteria

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)

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

Sponsors

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Sønderjylland

Aabenraa, , Denmark

Esbjerg Hospital, University Hospital of Southern Denmark

Esbjerg, , Denmark

Countries

Denmark

Other Identifiers

24/27699

Identifier Type: -

Identifier Source: org_study_id