Patient-posture and Ileal-intubation During Colonoscopy (PIC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Colonoscopy
• Intervention / Treatment: Procedure: Ileal intubation

• Study Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Kolkata, India, 700020
    • Recruiting
    • School of Digestive and Liver Diseases (SDLD), IPGME & R, Kolkata
    • Contact: K Das
    • Principal Investigator: Kshaunish Das

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: left lateral; 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; 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.; Other Names: Ileoscopy
Active Comparator: supine; After confirmation of cecal intubation, patient will undergo randomization to the supine position. Then terminal ileal intubation will be attempted.	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.; Other Names: Ileoscopy

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Kshaunish Das, MD, DM, Associate Professor, Division of Gastroenterology, SDLD, IPGME & R, Kolkata-700020

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): March 1, 2011

Study Registration Dates

• First Submitted: July 9, 2010
• First Submitted That Met QC Criteria: July 9, 2010
• First Posted (Estimate): July 12, 2010

Study Record Updates

• Last Update Posted (Estimate): July 12, 2010
• Last Update Submitted That Met QC Criteria: July 9, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Tuberculosis; endoscopy; IBD
• Other Study ID Numbers: SDLD001