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Completed

NCT Number: NCT01267981

Efficacy of Small Bowel Preparation in Capsule Endoscopy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier d'Avignon, Avignon, France

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About 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:

  • Inclusion
  • Randomization
  • Video-capsule exploration
  • Reading of the video-capsule exam by endoscopist doctors who are in blind.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard diet

Drug

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 polyethyleneglycol

Drug

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 glycol

Drug

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.

Primary outcomes

  1. Compare the frequencies of the diagnoses of clinically significant lesions

    Time frame: at the end of video-capsule exploration

    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.

Secondary outcomes

  1. The quality of the preparation and visibility of the bowel

    Time frame: at the end of video-capsule exploration

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

  2. The clinical tolerance

    Time frame: 8 days after video-capsule exploration

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

  3. The number of all the observed lesions

    Time frame: at the end of video-capsule exploration

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

  4. Compare different times

    Time frame: at the end of video-capsule exploration

    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).

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

    Time frame: At the end of video-capsule exploration

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Impact of Small Bowel Preparation Using Polyethylene Glycol for Endoscopic Video-capsule (EVC)Exploration in Unexplained Gastrointestinal Bleedings

Acronym: PREPINTEST

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Dec 29, 2010
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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