Clinical trial NCT06521658: Reduction of Pain in Colonoscopy - Loop First Versus Last
Official title: Reduction of Pain in Colonoscopy - Loop First Versus Last
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 1120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomisation
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Remembrance of pain
timeFrame: 15-60 minutes post colonoscopy
Secondary outcomes:
measure: Maximal pain
timeFrame: 15-60 minutes post colonoscopy
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Hospital Sønderjylland
city: Esbjerg
country: Denmark
facility: Esbjerg Hospital, University Hospital of Southern Denmark
Study officials:
References: