Efficacy of Small Bowel Preparation in Capsule Endoscopy

NCT01267981 | Completed Phase 3

• 1 other identifier: RB 09.091
• Study Type: interventional
• Target: 858
• Locations: 1 country
• Sites: 17

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.

Conditions

Gastrointestinal Bleedings

Keywords

Small bowel; video-capsule endoscopy; gastrointestinal bleeding; polyethylene glycol

Outcome Measures

Primary Outcomes (1)

• 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.

  at the end of video-capsule exploration

Secondary Outcomes (5)

• The quality of the preparation and visibility of the bowel

  at the end of video-capsule exploration

• The clinical tolerance

  8 days after video-capsule exploration

• The number of all the observed lesions

  at the end of video-capsule exploration

• Compare different times

  at the end of video-capsule exploration

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

  At the end of video-capsule exploration

Study Arms (3)

Preparation 1

PLACEBO COMPARATOR

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

Preparation 2

ACTIVE COMPARATOR

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

Preparation 3

ACTIVE COMPARATOR

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

Interventions

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.

Preparation 1

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.

Preparation 2

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.

Preparation 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Brest: lead
• Ministry of Health, France: collaborator

Study Sites (17)

Centre Hospitalier d'Avignon

Avignon, 84000, France

Location

Cabinet privé

Béziers, France

Location

Centre Hospitalier d'Avicenne

Bobigny, 93000, France

Location

CHOLET

Brest, 29200, France

Location

CHRU de Lille

Lille, 59037, France

Location

Saint Philibert Hospital

Lomme, 59160, France

Location

CH Bretagne Sud

Lorient, 56100, France

Location

Edouard Herriot Hospital

Lyon, 69437, France

Location

Hôpital de La Conception

Marseille, 13274, France

Location

Hôpital de la Timone

Marseille, 13385, France

Location

Centre Hospitalier Universitaire de Nice

Nice, 06202, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Höpital Européen Geores Pompidou

Paris, 75015, France

Location

CH de Cornouaille Quimper

Quimper, 29000, France

Location

Centre Hospitalier de Saint Brieuc

Saint-Brieuc, 22000, France

Location

Hôpital Privé de L'Est Lyonnais

Saint-Priest, 69800, France

Location

CH Bretagne Atlantique

Vannes, 56017, France

Location

Related Publications (1)

• 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.

  PMID: 35041627 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Franck CHOLET, MD

  CHRU Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2010
• First Posted: December 29, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 7, 2024

Record last verified: 2017-11

Locations

FR (17)