Efficacy of Small Bowel Preparation in Capsule Endoscopy (PREPINTEST)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01267981
First received: December 27, 2010
Last updated: April 13, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Gastrointestinal Bleedings
Drug: Standard diet
Drug: Standard Diet + 500 ml of polyethyleneglycol
Drug: Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Impact of Small Bowel Preparation Using Polyethylene Glycol for Endoscopic Video-capsule (EVC)Exploration in Unexplained Gastrointestinal Bleedings

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Compare the frequencies of the diagnoses of clinically significant lesions [ Time Frame: at the end of video-capsule exploration ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • The quality of the preparation and visibility of the bowel [ Time Frame: at the end of video-capsule exploration ] [ Designated as safety issue: No ]
    Demonstrate an improvement in preparation quality and bowel visibility in the various segments of small bowel examined by video-capsule endoscopy

  • The clinical tolerance [ Time Frame: 8 days after video-capsule exploration ] [ Designated as safety issue: Yes ]
    Evaluate the clinical tolerance and the acceptability of the bowel preparation with oral polyethylene glycol solution

  • The number of all the observed lesions [ Time Frame: at the end of video-capsule exploration ] [ Designated as safety issue: No ]
    Estimate the number of all the observed lesions on the recording according to their hemorrhagic potential.

  • Compare different times [ Time Frame: at the end of video-capsule exploration ] [ Designated as safety issue: No ]
    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).

  • Crossing (yes or no) of ileo-cecal valve by the EVC [ Time Frame: At the end of video-capsule exploration ] [ Designated as safety issue: No ]

Enrollment: 858
Study Start Date: September 2010
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Preparation 1
Standard diet: the day before video-capsule exploration : Drink only clears liquids after the lunch, fasting from 22 hours except usual drugs with a mouthful water.
Drug: Standard diet

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.

Active Comparator: Preparation 2

Standard diet : the day before video-capsule exploration : Drink only clears liquids after the lunch, fasting from 22 hours except usual drugs with a mouthful water.

500 ml of polyethylene glycol 30 minutes after the ingestion of video-capsule endoscopy.

Drug: Standard Diet + 500 ml of polyethyleneglycol
Apply the standard diet and drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.
Active Comparator: Preparation 3

Standard diet : the day before video-capsule exploration : Drink only clears liquids after the lunch, fasting from 22 hours except usual drugs with a mouthful water.

2 liters of polyethylene glycol between 7 pm and 9 pm.

500 ml of polyethylene glycol, 30 minutes after the ingestion of video-capsule endoscopy.

Drug: Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol
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.

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267981

Locations
France
Centre Hospitalier d'Avignon
Avignon, France, 84000
Cabinet privé
Beziers, France
Centre Hospitalier d'Avicenne
Bobigny, France, 93000
CHOLET
Brest, France, 29200
CHRU de Lille
Lille, France, 59037
Saint Philibert Hospital
Lomme, France, 59160
CH Bretagne Sud
Lorient, France, 56100
Edouard Herriot Hospital
Lyon, France, 69437
Hôpital de La Conception
Marseille, France, 13274
Hôpital de la Timone
Marseille, France, 13385
Centre Hospitalier Universitaire de Nice
Nice, France, 06202
Hôpital Cochin
Paris, France, 75014
Höpital Européen Geores Pompidou
Paris, France, 75015
CH de Cornouaille Quimper
Quimper, France, 29000
Centre Hospitalier de Saint Brieuc
Saint Brieuc, France, 22000
Hôpital Privé de L'Est Lyonnais
Saint Priest, France, 69800
CH Bretagne Atlantique
Vannes, France, 56017
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
Investigators
Principal Investigator: Franck CHOLET, MD CHRU Brest
  More Information

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01267981     History of Changes
Other Study ID Numbers: RB 09.091 
Study First Received: December 27, 2010
Last Updated: April 13, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
Small bowel
video-capsule endoscopy
gastrointestinal bleeding
polyethylene glycol

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 25, 2016