Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease

Crohn Disease Clinical Trial

— CROHN-PREP  

Official title:

Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease: a Prospective Randomized Controlled Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05117996
• Other study ID #: RC21_123
• Status: Completed
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: April 22, 2024

Study information

• Verified date: April 2024
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The European guidelines currently recommend to use 2 L of polyethylene glycol and free residue diet before any capsule endoscopy. However, up to now, no studies have been conducted to specifically evaluate bowel preparation modalities before small bowel capsule endoscopy in patients with Crohn's disease.

In patients with Crohn's disease and small bowel ulcers, polyethylene glycol may remove some fibrin from these ulcers and alter bowel preparation. Moreover, it is important to select the most acceptable bowel preparation because patients with Crohn's disease will have to repeat capsule endoscopy several times after initiating treatment, for monitoring under treatment, or for detection of post-operative recurrence.

In a preliminary retrospective study, it has been suggested that a simplified bowel preparation with liquid diet the evening before and water on the morning of the capsule endoscopy induced a better bowel preparation than the standard method with polyethylene glycol.

Thus, the aim of the study is to demonstrate the superiority of this simplified bowel preparation compared to the standard preparation modality in terms of quality of bowel preparation, patient's acceptability and diagnostic yield.

Description:

Crohn's disease is a chronic inflammatory bowel disease characterized by the presence of ulcers that can affect the entire digestive tract, from the mouth to the anus. The existence of small bowel lesions is pejorative and associated with poorer outcomes and a higher risk of intestinal resection.

Small bowel capsule endoscopy allows the visualization of the entire small bowel in a non-invasive and outpatient setting, without any anesthesia. It is the exam with the best diagnostic yield for the detection of small bowel ulcers in patients with Crohn's disease. Moreover, it allows the monitoring of patients after initiating treatment to assess mucosal healing and the detection of post-operative recurrence.

As for any endoscopic examinations, its acceptability depends on bowel preparation modalities. The European Society of Gastrointestinal Endoscopy (ESGE) currently recommends to use 2 L of polyethylene glycol and free residue diet before any capsule endoscopy. However, patients with Crohn's disease were a minority (< 1.5 %) in the studies on which these guidelines are based on.

Yet, in patients with small bowel Crohn's disease, polyethylene glycol may remove some fibrin from the ulcers and hence, alter bowel preparation. Moreover, it is important to select the most acceptable bowel preparation because patients with Crohn's disease will have to repeat capsule endoscopy several times after initiating treatment, for monitoring under treatment, or for detection of post-operative recurrence.

A preliminary retrospective study suggested that a simplified bowel preparation with liquid diet the evening before and water on the morning of the capsule endoscopy induced a better bowel preparation than the standard method with polyethylene glycol.

Thus, the aim of CROHN-PREP study is to demonstrate the superiority of this simplified bowel preparation compared to the standard preparation modality in terms of quality of bowel preparation, patient's acceptability and diagnostic yield.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: April 22, 2024
• Est. primary completion date: March 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patients of both genders aged over 18 years old

• With an established diagnosis of Crohn's disease, whether active or quiescent

• With an indication of a small bowel capsule endoscopy

• Without any small bowel stricture (patency capsule procedure on the 7 days before the capsule endoscopy)

• Registered with a social security scheme

• Having provided their oral consent for the study after appropriate information

Exclusion Criteria:

• - Patients aged below 18 years old

• Diagnosis of ulcerative colitis or IBD unclassified

• Presence of an ileostomy

• Presence of a small bowel syndrome

• Symptoms suggestive of a small bowel stricture

• Retention of the patency capsule on an abdominal X-ray performed 48 hours after the ingestion

• Abdominal pain after the ingestion of the patency capsule

• Planned abdominal surgery in the next month

• Known intestinal fistula

• Swallowing disorders

• Established diagnosis of delayed gastric emptying or suggestive symptoms

• Intake of non-steroidal anti-inflammatory drugs (NSAIDs) in the month prior to the capsule endoscopy

• Intake of oral iron supplementation in the week prior to the capsule endoscopy

• Intake of oral 5-ASA granules in the week prior to the capsule endoscopy

• Ongoing pregnancy

• Presence of a pace-maker or implantable defibrillator

• Known allergy to polyethylene glycol or to lactose

• Vulnerable people i.e. adults under a legal protection regime (guardianship, trusteeship, judicial safeguard)

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• capsule endoscopy
capsule endoscopy
• standard small bowel preparation
2 L of polyethylene glycol and free residue diet the day before the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule
• Simplified small bowel preparation
Liquid diet the evening before and water on the morning of the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Vendée departmental hospital	La Roche-sur-Yon
France	Clinique Jules Verne	Nantes
France	Hopital privé Confluent	Nantes
France	Nantes University Hospital	Nantes
France	Rennes University hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KODA score (entire small bowel)	Small bowel preparation quality (entire small bowel)	through the reading of the capsule endoscopy, an average of 6 months
Secondary	KODA score for each small bowel segment	Small bowel preparation quality (by segment : upper/middle/lower third)	through the reading of the capsule endoscopy, an average of 6 months
Secondary	Qualitative assessment by the reader	Proportion of images in which preparation is considered as "good", "moderate" or "low" by the reader (by segment)	through the reading of the capsule endoscopy, an average of 6 months
Secondary	Quantitative assessment of acceptability of preparation	Patient's acceptability of the bowel preparation on a visual analog scale between 0 (nil) to 10 (excellent)	Immediately before the capsule endoscopy
Secondary	Quantitative assessment on a visual analog scale between 0 (nil) to 10 (excellent)	Patient's acceptability of the examination on a visual analog scale between 0 (nil) to 10 (excellent)	Immediately before the capsule endoscopy
Secondary	Lewis score	Diagnostic yield evaluation	through the reading of the capsule endoscopy, an average of 6 months
Secondary	complete examinations	Percentage of complete examinations defined by the visualization of the first duodenal image and the first caecal image	through the reading of the capsule endoscopy, an average of 6 months
Secondary	Small bowel transit time	Recording time between the visualization of the first duodenal image and the first caecal image, if visualized	through the reading of the capsule endoscopy, an average of 6 months