Efficacy of Small Bowel Preparation in Capsule Endoscopy (PREPINTEST)

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 3

Conditions: Gastrointestinal Bleedings

Treatments: Drug: Standard Diet + 500 ml of polyethyleneglycol; Drug: Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol; Drug: Standard diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01267981

RB 09.091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 858 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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858 participants in 3 patient groups, including a placebo group

Preparation 1

Placebo Comparator group

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.

Treatment:

Drug: Standard diet

Preparation 2

Active Comparator group

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.

Treatment:

Drug: Standard Diet + 500 ml of polyethyleneglycol

Preparation 3

Active Comparator group

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.

Treatment:

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