Patient-posture and Ileal-intubation During Colonoscopy

NCT ID: NCT01159886

Last Updated: 2010-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-03-31

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.

Detailed Description

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Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ileal intubation

Intervention Type PROCEDURE

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.

supine

After confirmation of cecal intubation, patient will undergo randomization to the supine position. Then terminal ileal intubation will be attempted.

Group Type ACTIVE_COMPARATOR

Ileal intubation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Ileoscopy

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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Associate Professor, Division of Gastroenterology, SDLD, IPGME & R, Kolkata-700020

Principal Investigators

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Kshaunish Das, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Division of Gastroenterology, SDLD, IPGME & R, Kolkata-700020

Locations

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School of Digestive and Liver Diseases (SDLD), IPGME & R, Kolkata

Kolkata, , India

Site Status RECRUITING

Countries

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India

Central Contacts

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Kshaunish Das, MD, DM

Role: CONTACT

+91 9830349787

Facility Contacts

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K Das

Role: primary

Other Identifiers

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SDLD001

Identifier Type: -

Identifier Source: org_study_id

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