Reduction of Pain in Colonoscopy - Loop First Versus Last | NCT06521658

Studies
Reduction of Pain in Colonoscopy - Loop First Versus Last

NCT06521658

Sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Status

Completed

Last Update Posted

Feb 27, 2025Actual

Enrollment

1,120Actual

Phase

Not Applicable

Conditions

Pain

Interventions

Timing of retroflexion

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2024Actual

Primary Completion Date

Jan 15, 2025Actual

Completion Date

Jan 15, 2025Actual

First Submitted Date

Jul 15, 2024

First Submission Date that Met QC Criteria

Jul 25, 2024

First Posted Date

Jul 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2025

Last Update Posted Date

Feb 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Timing of retroflexion	Procedure	The intervention is the timing of the retroflexion/looping of the colonoscope in the rectum	loop last

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Maximal pain	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	15-60 minutes post colonoscopy

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Sønderjylland		Aabenraa		6200	Denmark
Esbjerg Hospital, University Hospital of Southern Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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