Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy

Phase 4

• Conditions: Bowel Preparation
• Interventions: Device: Capsule endoscopy; Drug: Polyethylene Glycol

• Registration Number: NCT02396017
• Lead Sponsor: Centro Hospitalar Lisboa Ocidental

Brief Summary

To compare the small bowel cleanliness for wireless capsule endoscopy using two different Polyethylene Glycol administration schedules (before the wireless capsule endoscopy ingestion versus in a split-dose fashion).

Detailed Description

The image quality obtained from the wireless capsule endoscopy improves its diagnostic yield. The amount of visualized mucosa is in direct correlation with the diagnostic yield. Nonetheless, frequently, the quality of the image obtained is hampered by the presence of bubbles, debris, bile and enteric fluid. Therefore many efforts have been putted in order to eliminate this factor such as the use of prokinetics, simethicone and bowel purgatives. The latter (namely the polyethylene glycol - PEG - solution) has accumulated evidence and is, therefore, recommended by the last European guidelines. Usually, the cleansing starts and finish in the day before the capsule endoscopy ingestion.

We hypothesized that, similarly to what had become evidence to large bowel cleansing, a shorter gap between the polyethylene glycol intake and the exam could provide a better capsule endoscopy image quality and therefore gauging our diagnostic yield.

Study Timeline

• Study First Submitted: 2015-02-18
• Status Verified: 2015-03
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-23
• Last Update Submitted: 2015-03-23
• Study First Posted: 2015-03-24
• Last Update Posted: 2015-03-24
• Primary Completion: 2015-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All adult patients referred to our institution for CE during the study period

Exclusion Criteria

• inpatients, bedridden, patients with clinical evidence of active bleeding, past history of abdominal surgery, abdominal or pelvic radiation therapy, occlusion, bowel perforation (suspected or confirmed), use of oral iron replacement therapy, severe cardiopulmonary, renal or hepatic disease, pregnancy, hypersensitivity to any components of the preparation, patients that didn't complete the preparation protocol, patients with incomplete enteroscopies (a complete enteroscopy is defined by the visualization of the mucosa from the duodenal bulb to the cecum), patients enrolled in other clinical studies and patients who didn't signed informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-dose Polyethylene Glycol regimen	Capsule endoscopy	Drug: Polyethylene Glycol Intervention: 2 liters of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion.
Single-dose Polyethylene Glycol regimen	Polyethylene Glycol	Drug: Polyethylene Glycol Intervention: 2 liters of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion.
Split-dose Polyethylene Glycol regimen	Capsule endoscopy	Drug: Polyethylene Glycol Intervention: 1 liter of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion and another 1 liter Polyethylene Glycol will be given in the same day of Capsule Endoscopy ingestion.
Split-dose Polyethylene Glycol regimen	Polyethylene Glycol	Drug: Polyethylene Glycol Intervention: 1 liter of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion and another 1 liter Polyethylene Glycol will be given in the same day of Capsule Endoscopy ingestion.

Primary Outcome Measures

Name	Time	Method
Small-bowel cleanliness	at the end of capsule endoscopy exploration	The cleansing quality of the small-bowel will be evaluated according to the system validated by Brotz et al., using the quantitative index (QI), because this score is less susceptible to the subjective element. The used cut-off value accepted for an adequate small-bowel cleansing was ≥ 8 points.

Secondary Outcome Measures

Name	Time	Method
The clinical tolerance questionnaire	at the end of capsule endoscopy exploration	Evaluate the clinical tolerance and the acceptability of the bowel preparation with the oral polyethylene glycol solution.
The transit time	at the end of capsule endoscopy exploration	Compare gastric transit time and the small bowel transit time.
The number of all the observed lesions	at the end of capsule endoscopy exploration	Estimate the number of all the observed lesions on the recording according to their hemorrhagic potential.

Trial Locations

Locations (1)

Gastroenterology Department, Hospital Egas Moniz; 🇵🇹 Lisboa, Portugal