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Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

Primary Purpose

Colon Cancer, Inflammatory Bowel Diseases, Gastrointestinal Bleed

Status
Recruiting
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
polyethylene glycol
sodium phosphate
polyethylene glycol + ascorbic acid
gastrografin
magnesiumoxid + sodium picosulfate
prucalopride
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Cancer focused on measuring colon capsule endoscopy, panenteric capsule endoscopy, colon preparation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject referred for clinical colon/panenteric examination Subject received an explanation about the nature of the study and agreed to provide written informed consent Exclusion Criteria: Subject with dysphagia or any swallowing disorder Subject with a prior stomach, small bowel, or colonic resection Subject with severe renal insufficiency Subject with any allergy or other known contraindication to the medications used in the study Women who are either pregnant or nursing Subject suffers from life threatening conditions

Sites / Locations

  • Skåne University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard preparation regimen

Optimized preparation regimen

Optimized preparation regimen with prucalopride

Arm Description

4 L polyethylene glycol as laxative 30 + 15 mL sodium phosphate as a booster

1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster

1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster + 2 mg of prucalopride

Outcomes

Primary Outcome Measures

Completeness rate
Visualization of the hemorrhoidal plexus or an excreted capsule
Adequate cleanliness rate
Assessment of the quality of the bowel preparation using a the 4-point Leighton-Rex scale

Secondary Outcome Measures

Transit times
Determining the amount of time for the capsule to transit through the stomach, small bowel and large bowel for the different preparations
Diagnostic yield
Findings in the small and large bowel
Assessment of patient tolerance of the bowel preparations
Survey questionnaire to be completed by participants at the time of the colon capsule endoscopy assessing the tolerability of the preparation and side effects

Full Information

First Posted
December 22, 2022
Last Updated
March 31, 2023
Sponsor
Region Skane
Collaborators
Lund University, Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05726097
Brief Title
Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure
Official Title
Optimization of the Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Lund University, Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to investigate the effect of the optimized bowel preparation and boost regimens on colon capsule endoscopy procedures, specifically on cleanliness and completion rate.
Detailed Description
Colon capsule endoscopy (CCE) is a promising modality for lower gastrointestinal (GI) investigations in clinical routine and screening. Furthermore, the double-headed camera capsules are being applied for panenteric investigations, with promising results. The major limitation to its use has been finding a bowel preparation that will clean the colon adequately for good visualization of the mucosa and help propel the capsule using boosters through the colon. To achieve wider CCE adoption, challenges regarding completion rates (CR) and adequate cleanliness rates (ACR) must be handled. CR and ACR should be improved to meet the standards for optical colonoscopy (OC) from the European Society of GI Endoscopy (ESGE). ESGE recommends both CR and ACR ≥ 90%. Recently, a meta-analysis of preparation regimens for CCE confirmed that CR and ACR were suboptimal. This study is designed to investigate the CR, ACR, and diagnostic yield (DY) of very low-volume polyethylene glycol (PEG) - based laxative compared to a conventional high-volume laxative and the use of different boosters. All consecutive patients referred for colon capsule endoscopy will be enrolled in the study. PillCam® Crohn's capsule will be used. Patients will undergo a split-dose bowel preparation with a very low-volume PEG-based laxative. In the study arm nr1 gastrografin and magnesiumoxid + sodium picosulfate will be used. In the study arm Nr 2, the same regimen will be used but completed with 2 mg of prucalopride before ingesting the capsule. The results of the study arms will be compared to the previously used standard regimen with 4 L of PEG as a laxative and sodium phosphate as a booster. The images from the colon capsule will be reviewed, and the quality of bowel preparation (cleanliness rates) and completion rate will be evaluated. Patient tolerance of the bowel preparations and diagnostic yield of colon capsule endoscopy using the different preparation regimens will also be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Inflammatory Bowel Diseases, Gastrointestinal Bleed, Colon Polyp
Keywords
colon capsule endoscopy, panenteric capsule endoscopy, colon preparation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
147 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard preparation regimen
Arm Type
Active Comparator
Arm Description
4 L polyethylene glycol as laxative 30 + 15 mL sodium phosphate as a booster
Arm Title
Optimized preparation regimen
Arm Type
Experimental
Arm Description
1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster
Arm Title
Optimized preparation regimen with prucalopride
Arm Type
Experimental
Arm Description
1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster + 2 mg of prucalopride
Intervention Type
Drug
Intervention Name(s)
polyethylene glycol
Other Intervention Name(s)
Laxabon
Intervention Description
colonic preparation
Intervention Type
Drug
Intervention Name(s)
sodium phosphate
Other Intervention Name(s)
Phosphoral
Intervention Description
colonic preparation
Intervention Type
Drug
Intervention Name(s)
polyethylene glycol + ascorbic acid
Other Intervention Name(s)
Plenvu
Intervention Description
colonic preparation
Intervention Type
Drug
Intervention Name(s)
gastrografin
Intervention Description
colonic preparation
Intervention Type
Drug
Intervention Name(s)
magnesiumoxid + sodium picosulfate
Other Intervention Name(s)
Picoprep
Intervention Description
colonic preparation
Intervention Type
Drug
Intervention Name(s)
prucalopride
Other Intervention Name(s)
Resolol
Intervention Description
colonic preparation
Primary Outcome Measure Information:
Title
Completeness rate
Description
Visualization of the hemorrhoidal plexus or an excreted capsule
Time Frame
Within 3 months after completed capsule colonoscopy
Title
Adequate cleanliness rate
Description
Assessment of the quality of the bowel preparation using a the 4-point Leighton-Rex scale
Time Frame
Within 3 months after completed capsule colonoscopy
Secondary Outcome Measure Information:
Title
Transit times
Description
Determining the amount of time for the capsule to transit through the stomach, small bowel and large bowel for the different preparations
Time Frame
Within 3 months after completed capsule colonoscopy
Title
Diagnostic yield
Description
Findings in the small and large bowel
Time Frame
Within 3 months after completed capsule colonoscopy
Title
Assessment of patient tolerance of the bowel preparations
Description
Survey questionnaire to be completed by participants at the time of the colon capsule endoscopy assessing the tolerability of the preparation and side effects
Time Frame
Within 3 months after completed capsule colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject referred for clinical colon/panenteric examination Subject received an explanation about the nature of the study and agreed to provide written informed consent Exclusion Criteria: Subject with dysphagia or any swallowing disorder Subject with a prior stomach, small bowel, or colonic resection Subject with severe renal insufficiency Subject with any allergy or other known contraindication to the medications used in the study Women who are either pregnant or nursing Subject suffers from life threatening conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ervin Toth, MD PhD
Phone
+4640331000
Email
ervin.toth@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ervin Toth, MD PhD
Organizational Affiliation
Department of Gastroenterology, Skåne University Hospital, Malmö, Lund University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skåne University Hospital
City
Malmö
ZIP/Postal Code
20502
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ervin Toth, MD PhD
Phone
+4640331000
Email
ervin.toth@med.lu.se

12. IPD Sharing Statement

Plan to Share IPD
No

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Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

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