Left Lateral Tilt-down Position During Colonoscopy Insertion

NCT ID: NCT02842489

Last Updated: 2018-10-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-06-30

Brief Summary

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The purpose of this study is to determine whether the left lateral tilt-down position, which includes procedures that involve placing patients on their left lateral side at an angle to make their heads lower than their feet, is more beneficial than the left lateral horizontal body position (patient horizontally laying on their left side, traditionally used for colonoscopies) to decrease descending colon insertion time, the difficulty of colonoscopy procedure and patients' pain.

Detailed Description

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Supine with tilt-down position (trendelenburg position) is used in abdominal and gynecological surgery to allow better access to the pelvic organs, as gravity pulls the bowel out of the pelvic cavity and the rectosigmoid angle straightens, which may also be favorable for colonoscopy insertion. However, few published studies have explored the value of tilt-down position in the colonoscopy (left lateral horizontal body position are usually used) and there is consequently little evidence to support left lateral tilt-down position or left lateral horizontal body position. So the investigators perform a randomized controlled trial of left lateral tilt-down position versus left lateral horizontal position for colonoscopy to investigate the safety and efficacy of lateral tilt-down position.

Conditions

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Colonoscopy Insertion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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left lateral tilt-down position

patients will be positioned on left lateral tilt-down position during colonoscopy until sigmoid-descending junction were examined, and then patients will be positioned on the left lateral horizontal position during colonoscopy

Group Type EXPERIMENTAL

left lateral tilt-down position

Intervention Type PROCEDURE

patients will be positioned on their left side and at an angle of 20 degree

left lateral horizontal body position

patients will be positioned on the left lateral horizontal position during colonoscopy insertion

Group Type ACTIVE_COMPARATOR

left lateral horizontal position

Intervention Type PROCEDURE

patients will be horizontally positioned on their left side

Interventions

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left lateral tilt-down position

patients will be positioned on their left side and at an angle of 20 degree

Intervention Type PROCEDURE

left lateral horizontal position

patients will be horizontally positioned on their left side

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients whose age is between 18-75
2. Patients who have indications for diagnostic or therapeutic colonoscopy .
3. Patients who have signed inform consent form

Exclusion Criteria

1. Patients who have undergone colonic resection
2. Patients with glaucoma
3. Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
4. Patients with severe chronic cardiopulmonary and renal disease.
5. Patients with uncontrolled acid reflux disease or active nausea/vomiting.
6. Patients who are unwilling or unable to consent.
7. Patients who are not suitable for colonoscopy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of Gastroenterology Dept and Digestive Endoscopy Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Zhaoshen, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Changhai Hospital, Second Military Medical University

Shanghai, , China

Site Status

Countries

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China

References

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Zhao SB, Yang X, Fang J, Wang SL, Gu L, Xia T, Su XJ, Wang D, Li ZS, Bai Y. Effect of left lateral tilt-down position on cecal intubation time: a 2-center, pragmatic, randomized controlled trial. Gastrointest Endosc. 2018 Mar;87(3):852-861. doi: 10.1016/j.gie.2017.11.012. Epub 2017 Nov 20.

Reference Type DERIVED
PMID: 29158180 (View on PubMed)

Other Identifiers

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body position-1

Identifier Type: -

Identifier Source: org_study_id

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