NCT01159886

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

July 12, 2010

Status Verified

July 1, 2010

Enrollment Period

7 months

First QC Date

July 9, 2010

Last Update Submit

July 9, 2010

Conditions

Colonoscopy

Keywords

TuberculosisIBDendoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

left lateral

ACTIVE COMPARATOR

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

supine

ACTIVE COMPARATOR

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

Procedure: Ileal intubation

Interventions

Ileal intubationPROCEDURE

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.

Also known as: Ileoscopy
left lateralsupine

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All adult (\> 12y old) patients referred for colonoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kolkata, 700020, India

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Kshaunish Das, MD, DM

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kshaunish Das, MD, DM

CONTACT

+91 9830349787dockdas@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2010

First Posted

July 12, 2010

Study Start

June 1, 2010

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

July 12, 2010

Record last verified: 2010-07

Locations

IN(1)