Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lund University | OTHER |
| Odense University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard preparation regimen | Active Comparator | 4 L polyethylene glycol as laxative 30 + 15 mL sodium phosphate as a booster |
|
| Optimized preparation regimen | Experimental | 1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster |
|
| Optimized preparation regimen with prucalopride | Experimental | 1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster + 2 mg of prucalopride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polyethylene glycol | Drug | colonic preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completeness rate | Visualization of the hemorrhoidal plexus or an excreted capsule | Within 3 months after completed capsule colonoscopy |
| Adequate cleanliness rate | Assessment of the quality of the bowel preparation using a the 4-point Leighton-Rex scale | Within 3 months after completed capsule colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Transit times | Determining the amount of time for the capsule to transit through the stomach, small bowel and large bowel for the different preparations | Within 3 months after completed capsule colonoscopy |
| Diagnostic yield |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ervin Toth, MD PhD | Department of Gastroenterology, Skåne University Hospital, Malmö, Lund University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital | Malmö | 20502 | Sweden |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 22, 2022 | Jan 19, 2023 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015212 | Inflammatory Bowel Diseases |
| D006471 | Gastrointestinal Hemorrhage |
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| C018279 | sodium phosphate |
| D001205 | Ascorbic Acid |
| D003974 | Diatrizoate Meglumine |
| C005701 | picosulfate sodium |
| C406662 | prucalopride |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| sodium phosphate | Drug | colonic preparation |
|
|
| polyethylene glycol + ascorbic acid | Drug | colonic preparation |
|
|
| gastrografin | Drug | colonic preparation |
|
| magnesiumoxid + sodium picosulfate | Drug | colonic preparation |
|
|
| prucalopride | Drug | colonic preparation |
|
|
Findings in the small and large bowel
| Within 3 months after completed capsule colonoscopy |
| 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 | Within 3 months after completed capsule colonoscopy |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005759 | Gastroenteritis |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D008536 | Meglumine |
| D013012 | Sorbitol |
| D013402 | Sugar Alcohols |
| D003973 | Diatrizoate |
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006595 | Hexosamines |
| D000606 | Amino Sugars |