CROHN-PREP: Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease

Sponsor
Nantes University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05117996
Collaborator
(none)
144
6
2
23.9
24
1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: capsule endoscopy
  • Other: standard small bowel preparation
  • Other: Simplified small bowel preparation
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Masking Description:
Single blind
Primary Purpose:
Other
Official Title:
Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease: a Prospective Randomized Controlled Multicenter Study
Actual Study Start Date :
Jul 5, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard small bowel preparation

2 L of polyethylene glycol and free residue diet the day before the capsule endoscopy

Other: capsule endoscopy
capsule endoscopy

Other: standard small bowel preparation
2 L of polyethylene glycol and free residue diet the day before the capsule endoscopy

Experimental: Simplified small bowel preparation

Liquid diet the evening before and water on the morning of the capsule endoscopy

Other: capsule endoscopy
capsule endoscopy

Other: Simplified small bowel preparation
Liquid diet the evening before and water on the morning of the capsule endoscopy

Outcome Measures

Primary Outcome Measures

  1. KODA score (entire small bowel) [through the reading of the capsule endoscopy, an average of 6 months]

    Small bowel preparation quality (entire small bowel)

Secondary Outcome Measures

  1. KODA score for each small bowel segment [through the reading of the capsule endoscopy, an average of 6 months]

    Small bowel preparation quality (by segment : upper/middle/lower third)

  2. Qualitative assessment by the reader [through the reading of the capsule endoscopy, an average of 6 months]

    Proportion of images in which preparation is considered as "good", "moderate" or "low" by the reader (by segment)

  3. Quantitative assessment of acceptability of preparation [Immediately before the capsule endoscopy]

    Patient's acceptability of the bowel preparation on a visual analog scale between 0 (nil) to 10 (excellent)

  4. Quantitative assessment on a visual analog scale between 0 (nil) to 10 (excellent) [Immediately before the capsule endoscopy]

    Patient's acceptability of the examination on a visual analog scale between 0 (nil) to 10 (excellent)

  5. Lewis score [through the reading of the capsule endoscopy, an average of 6 months]

    Diagnostic yield evaluation

  6. complete examinations [through the reading of the capsule endoscopy, an average of 6 months]

    Percentage of complete examinations defined by the visualization of the first duodenal image and the first caecal image

  7. Small bowel transit time [through the reading of the capsule endoscopy, an average of 6 months]

    Recording time between the visualization of the first duodenal image and the first caecal image, if visualized

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Angers University Hospital Angers France
2 Brest University hospital Brest France
3 Cholet hospital Cholet France
4 Vendée departmental hospital La Roche-sur-Yon France
5 Nantes University Hospital Nantes France
6 Rennes University hospital Rennes France

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT05117996
Other Study ID Numbers:
  • RC21_123
First Posted:
Nov 11, 2021
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2022