Efficacy of Small Bowel Preparation in Capsule Endoscopy

University Hospital, Brest858 enrolled

Overview

The best preparation of small bowel is still unknown. The primary aim of this study is to evaluate the polyethylene glycol (PEG) impact of small bowel preparation for unexplained gastrointestinal bleeding exploration. Three different preparations are evaluated in this study.

Now days, the endoscopic video-capsule is the more appropriate exam for unexplained gastrointestinal bleeding exploration. The responsible damage of this unexplained bleeding are frequently small vascular damages, hard to be detected in the bowel or ulcerations or tumors. The exam quality can be limited by food residues, bubbles or bile. 30% of damage are probably undetectable because of a lack of visibility. An efficient preparation will probably increased the quality of the video-capsule exploration. The bowel exploration by endoscopy video-capsule will be realized in the usual condition. The study included 4 steps: 1. Inclusion 2. Randomization 3. Video-capsule exploration 4. Reading of the video-capsule exam by endoscopist doctors who are in blind.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

858

Conditions

Gastrointestinal Bleedings

Interventions

Standard dietDRUG

After the lunch the day before the exploration, drink only clear liquids and stop solid food. From 10 pm, stay fasting, don't drink except the usual drugs taken with mouthful of water until the exploration by video-capsule endoscopy.

Standard Diet + 500 ml of polyethyleneglycolDRUG

Apply the standard diet and drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.

Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycolDRUG

apply the standard diet and drink 2 liters of polyethylene glycol between 19h and 21h the day before exploration. Then drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>= 18 years old. * Patients who have an indication for video-capsule endoscopy exploration for unexplained gastrointestinal bleeding associated with anaemia (man : haemoglobin \<13 g/dl and woman haemoglobin \<12g/dl) * Less than one year Endoscopic assessment by colonoscopy and gastroscopy * Not participated to an another clinic study. * Written consent. Exclusion Criteria: * Age\<18 years old. * General physical health deterioration such as dehydration or cardiac insufficiency. * Clinical or radiological suspicion of digestive stenosis. * Oral iron taking in the 4 days before video-capsule exploration. * Functional or organic disorders of the gulp * Pregnant women. * Sensibility known about the polyethylene glycol. * No signed consent.

Locations (17)

Centre Hospitalier d'Avignon

Avignon, France

Cabinet privé

Béziers, France

Centre Hospitalier d'Avicenne

Bobigny, France

Outcomes

Primary Outcomes

Compare the frequencies of the diagnoses of clinically significant lesions

Compare the frequencies of the diagnoses of clinically significant lesions (P1 or P2)obtained with and without polyethylene glycol preparation for patients investigated by video-capsule endoscopy who have an unexplained digestive bleeding.

Time frame: at the end of video-capsule exploration

Secondary Outcomes

The quality of the preparation and visibility of the bowel

Demonstrate an improvement in preparation quality and bowel visibility in the various segments of small bowel examined by video-capsule endoscopy

Time frame: at the end of video-capsule exploration

The clinical tolerance

Evaluate the clinical tolerance and the acceptability of the bowel preparation with oral polyethylene glycol solution

Time frame: 8 days after video-capsule exploration

The number of all the observed lesions

Estimate the number of all the observed lesions on the recording according to their hemorrhagic potential.

Time frame: at the end of video-capsule exploration

Compare different times

Compare gastric emptying time, the bowel transit time and the percentage complete medical exploration of small bowel for every group of patients (ileo- cecal valve exceeded).

Time frame: at the end of video-capsule exploration

Crossing (yes or no) of ileo-cecal valve by the EVC

Time frame: At the end of video-capsule exploration

Data from ClinicalTrials.gov

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