Patient-posture and Ileal-intubation During Colonoscopy

Study Overview
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Brief Summary
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During colonoscopy, the colonoscopist employs various maneuvers, including changing the patient's posture to left-lateral decubitus or supine, to achieve complete colonoscopic examination. Posture change has also been reported to increase the success rate of ileal intubation. However, there has been no randomized trial which has shown that a particular posture of the patient increases the success rate of ileoscopy. The present study will be carried out to determine the impact of the patient's posture (left lateral vs supine position) on success rate of ileal intubation.

Official Title
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Patient-posture and Ileal-intubation During Colonoscopy (PIC): a Randomized Controlled Open-label Trial

Conditions
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Colonoscopy

Intervention / Treatment
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* Procedure: Ileal intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult (> 12y old) patients referred for colonoscopy Exclusion Criteria: Acute fulminant colitis Acute Intestinal obstruction Suspected intestinal perforation Peritonitis Pregnancy Severe cardio-respiratory disease (ASA grade…) Decompensated liver disease Recent pelvic or colonic surgery (in last 6 months) Large aortic or ileac artery aneurysm Human Immunodeficiency Virus Infection Uncooperative patients

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: left lateral<br>After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus position. Then terminal ileal intubation will be attempted. | Procedure: Ileal intubation<br>* After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus or supine position. Then terminal ileal intubation will be attempted. Partial suction and scope manoeuvres for ileal intubation will be allowed. Use of anti-peristalsis agents, use of biopsy forceps, as a guidewire or an ''anchor'' to facilitate the IC- valve intubation, and intubation in the retroflexed position will not be allowed.<br>* Other names: Ileoscopy;|
| Active Comparator: supine<br>After confirmation of cecal intubation, patient will undergo randomization to the supine position. Then terminal ileal intubation will be attempted. | Procedure: Ileal intubation<br>* After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus or supine position. Then terminal ileal intubation will be attempted. Partial suction and scope manoeuvres for ileal intubation will be allowed. Use of anti-peristalsis agents, use of biopsy forceps, as a guidewire or an ''anchor'' to facilitate the IC- valve intubation, and intubation in the retroflexed position will not be allowed.<br>* Other names: Ileoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ileal intubation achieved or not | After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus or supine position. Then terminal ileal intubation will be attempted. Two points will be assessed: success in ileal intubation and time taken to intubate the ileum. If ileum is not intubated within 6 minutes, it will be considered as failed attempt. | After confirmation of cecal intubation for no more than 6 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken to intubate the ileum after cecal intubation |  | 6 minutes after cecal intubation and randomisation | 
| Depth of ileal intubation |  | 2 minutes | 
| Influence of endoscopist experience on successful ileal intubation |  | 6 minutes | 
| Abnormal ileal findings |  | 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tuberculosis, IBD, endoscopy