Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-27 @ 7:06 AM
Study NCT ID:
NCT06521658
Status:
COMPLETED
Last Update Posted:
2025-02-27
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Pain in Colonoscopy - Loop First Versus Last
Sponsor:
Esbjerg Hospital - University Hospital of Southern Denmark
Organization:
Study Overview
Official Title:
Reduction of Pain in Colonoscopy - Loop First Versus Last
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: