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Patient-posture and Ileal-intubation During Colonoscopy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01159886
Acronym
PIC
Enrollment
216
Registered
2010-07-12
Start date
2010-06-30
Completion date
2011-03-31
Last updated
2010-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy

Keywords

Tuberculosis, IBD, endoscopy

Brief summary

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.

Interventions

PROCEDUREIleal intubation

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.

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ileal intubation achieved or notAfter confirmation of cecal intubation for no more than 6 minutesAfter 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.

Secondary

MeasureTime frame
Time taken to intubate the ileum after cecal intubation6 minutes after cecal intubation and randomisation
Depth of ileal intubation2 minutes
Influence of endoscopist experience on successful ileal intubation6 minutes
Abnormal ileal findings2 minutes

Countries

India

Contacts

Primary ContactKshaunish Das, MD, DM
dockdas@gmail.com+91 9830349787

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026