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OpenTrials
Completed

NCT Number: NCT06521658

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sønderjylland, Aabenraa, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Timing of retroflexion

Procedure

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

Primary outcomes

  1. Remembrance of pain

    Time frame: 15-60 minutes post colonoscopy

    Visual Analogue Pain (VAS) score of pain. The score is from 0-100 where a smaller score means less pain.

Secondary outcomes

  1. Maximal pain

    Time frame: 15-60 minutes post colonoscopy

    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

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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