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Efficacy of Small Bowel Preparation in Capsule Endoscopy (PREPINTEST)

Primary Purpose

Gastrointestinal Bleedings

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Standard diet
Standard Diet + 500 ml of polyethyleneglycol
Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Bleedings focused on measuring Small bowel, video-capsule endoscopy, gastrointestinal bleeding, polyethylene glycol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier d'Avignon
  • Cabinet privé
  • Centre Hospitalier d'Avicenne
  • CHOLET
  • CHRU de Lille
  • Saint Philibert Hospital
  • CH Bretagne Sud
  • Edouard Herriot Hospital
  • Hôpital de La Conception
  • Hôpital de la Timone
  • Centre Hospitalier Universitaire de Nice
  • Hôpital Cochin
  • Höpital Européen Geores Pompidou
  • CH de Cornouaille Quimper
  • Centre Hospitalier de Saint Brieuc
  • Hôpital Privé de L'Est Lyonnais
  • CH Bretagne Atlantique

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Preparation 1

Preparation 2

Preparation 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
The clinical tolerance
Evaluate the clinical tolerance and the acceptability of the bowel preparation with oral polyethylene glycol solution
The number of all the observed lesions
Estimate the number of all the observed lesions on the recording according to their hemorrhagic potential.
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).
Crossing (yes or no) of ileo-cecal valve by the EVC

Full Information

First Posted
December 27, 2010
Last Updated
June 6, 2016
Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01267981
Brief Title
Efficacy of Small Bowel Preparation in Capsule Endoscopy
Acronym
PREPINTEST
Official Title
Impact of Small Bowel Preparation Using Polyethylene Glycol for Endoscopic Video-capsule (EVC)Exploration in Unexplained Gastrointestinal Bleedings
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Bleedings
Keywords
Small bowel, video-capsule endoscopy, gastrointestinal bleeding, polyethylene glycol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
858 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preparation 1
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Preparation 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Preparation 3
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard diet
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard Diet + 500 ml of polyethyleneglycol
Intervention Description
Apply the standard diet and drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.
Intervention Type
Drug
Intervention Name(s)
Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol
Intervention Description
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 Outcome Measure Information:
Title
Compare the frequencies of the diagnoses of clinically significant lesions
Description
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 Outcome Measure Information:
Title
The quality of the preparation and visibility of the bowel
Description
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
Title
The clinical tolerance
Description
Evaluate the clinical tolerance and the acceptability of the bowel preparation with oral polyethylene glycol solution
Time Frame
8 days after video-capsule exploration
Title
The number of all the observed lesions
Description
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
Title
Compare different times
Description
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
Title
Crossing (yes or no) of ileo-cecal valve by the EVC
Time Frame
At the end of video-capsule exploration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck CHOLET, MD
Organizational Affiliation
CHRU Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier d'Avignon
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Cabinet privé
City
Beziers
Country
France
Facility Name
Centre Hospitalier d'Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
CHOLET
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Saint Philibert Hospital
City
Lomme
ZIP/Postal Code
59160
Country
France
Facility Name
CH Bretagne Sud
City
Lorient
ZIP/Postal Code
56100
Country
France
Facility Name
Edouard Herriot Hospital
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hôpital de La Conception
City
Marseille
ZIP/Postal Code
13274
Country
France
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Hospitalier Universitaire de Nice
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Höpital Européen Geores Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CH de Cornouaille Quimper
City
Quimper
ZIP/Postal Code
29000
Country
France
Facility Name
Centre Hospitalier de Saint Brieuc
City
Saint Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
Hôpital Privé de L'Est Lyonnais
City
Saint Priest
ZIP/Postal Code
69800
Country
France
Facility Name
CH Bretagne Atlantique
City
Vannes
ZIP/Postal Code
56017
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35041627
Citation
Rahmi G, Cholet F, Gaudric M, Filippi J, Duburque C, Bramli S, Quentin V, Alavi Z, Nowak E, Saurin JC, Cellier C, Queneherve L; PREPINTEST working group. Effect of Different Modalities of Purgative Preparation on the Diagnostic Yield of Small Bowel Capsule for the Exploration of Suspected Small Bowel Bleeding: A Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2022 Feb 1;117(2):327-335. doi: 10.14309/ajg.0000000000001597.
Results Reference
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Efficacy of Small Bowel Preparation in Capsule Endoscopy

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