Left Lateral Tilt-down Position During Colonoscopy Insertion

NCT02842489 | Completed DMC

• 1 other identifier: body position-1
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonoscopy Insertion

Keywords

colonoscopy insertion; tilt-down position

Outcome Measures

Primary Outcomes (1)

• cecal colon insertion time

  This outcome is measured when cecal colon is intubated during a colonoscopy

Secondary Outcomes (3)

• patients' discomfort of colonoscopy

  2 hours

• endoscopists' perception of difficulty of colonoscopy

  2 hours

• decending insertion time

  This outcome is measured when decending colon is intubated during a colonoscopy

Study Arms (2)

left lateral tilt-down position

EXPERIMENTAL

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

Procedure: left lateral tilt-down position

left lateral horizontal body position

ACTIVE COMPARATOR

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

Procedure: left lateral horizontal position

Interventions

left lateral tilt-down position PROCEDURE

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

left lateral tilt-down position

left lateral horizontal position PROCEDURE

patients will be horizontally positioned on their left side

left lateral horizontal body position

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who have undergone colonic resection
• Patients with glaucoma
• Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
• Patients with severe chronic cardiopulmonary and renal disease.
• Patients with uncontrolled acid reflux disease or active nausea/vomiting.
• Patients who are unwilling or unable to consent.
• Patients who are not suitable for colonoscopy

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

Location

Related Publications (1)

• 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.

  PMID: 29158180 DERIVED

Study Officials

• Li Zhaoshen, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology Dept and Digestive Endoscopy Center

Study Record Dates

• First Submitted: June 26, 2016
• First Posted: July 25, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

CN (1)