Patient-posture and Ileal-intubation During Colonoscopy

Colonoscopy Clinical Trial

— PIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01159886
• Other study ID #: SDLD001
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2010
• Last updated: July 9, 2010
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: July 2010
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Kshaunish Das, MD, DM
• Phone: +91 9830349787
• Email: dockdas[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Procedure:
• Ileal 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.

Locations

Country	Name	City	State
India	School of Digestive and Liver Diseases (SDLD), IPGME & R, Kolkata	Kolkata

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time taken to intubate the ileum after cecal intubation		6 minutes after cecal intubation and randomisation	No
Secondary	Depth of ileal intubation		2 minutes	No
Secondary	Influence of endoscopist experience on successful ileal intubation		6 minutes	No
Secondary	Abnormal ileal findings		2 minutes	No