Left Lateral Tilt-down Position During Colonoscopy Insertion

The Role of Left Lateral Tilt-down Position During Colonoscopy Insertion: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy Insertion
• Intervention / Treatment: Procedure: left lateral tilt-down position; Procedure: left lateral horizontal position

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 258
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200433
    • Changhai Hospital, Second Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Procedure: left lateral tilt-down position; patients will be positioned on their left side and at an angle of 20 degree
ACTIVE_COMPARATOR: left lateral horizontal body position; patients will be positioned on the left lateral horizontal position during colonoscopy insertion	Procedure: left lateral horizontal position; patients will be horizontally positioned on their left side

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cecal colon insertion time	This outcome is measured when cecal colon is intubated during a colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patients' discomfort of colonoscopy	patients' discomfort will be assessed by a 10-cm visual analog scale	2 hours
endoscopists' perception of difficulty of colonoscopy	difficulty of colonoscopy will be assessed by a 10-cm visual analog scale	2 hours
decending insertion time		This outcome is measured when decending colon is intubated during a colonoscopy

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Li Zhaoshen, MD, Changhai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: June 26, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (ESTIMATE): July 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: colonoscopy insertion; tilt-down position
• Other Study ID Numbers: body position-1