Supine Position for Colonoscopy Insertion

Impact of Supine Position on Colonoscopy Insertion: a Randomized Controlled Trial

The purpose of this study is to determine whether the supine position is better than the left lateral horizontal body position to decrease cecal intubation time, patients' pain and the difficulty of colonoscopy insertion.

Study Overview

• Status: Completed
• Conditions: Colonoscopy Insertion; Patient Position
• Intervention / Treatment: Procedure: supine position

Detailed Description

Left lateral position is conventionally performed to initiate colonoscopy, yet no evidence has demonstrated its efficacy and advantages. Left lateral position for insertion, which results in air rising away from the left colon and producing acute bends in the sigmoid,might increase the risk of colonoscopy loop formation.When there is difficulty advancing the colonoscope, supine position can be employed to ensure cecal intubation. Therefore, we perform a randomized controlled trial to compares supine position with left lateral position for the safety and efficacy of colonoscopy insertion.

• Study Type: Interventional
• Enrollment (Actual): 347
• 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: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. aged between 18-75 years
2. underwent screening, surveillance, and diagnostic colonoscopy

Exclusion Criteria:

1. <18 or >75 years old
2. major psychiatric disorders, colonic resection, pregnancy, presence of any contraindications for colonoscopy (eg, severe heart failure, renal insufficiency)
3. Patients with severe cardiopulmonary and renal disease
4. Patients who are unwilling or unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: supine position group	Procedure: supine position; patients were positioned on their supine position to receive colonoscopy insertion
No Intervention: left lateral position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cecal intubation time	Cecal intubation time is the insertion time taken from first visualization of rectal mucosa to cecum and cecal intubation was confirmed by identifying the characteristic anatomical landmarks of the triradiate fold, appendiceal orifice, and ileocecal valve.	2 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
descending colon intubation time	Descending colon intubation time is the insertion time taken from first visualization of rectal mucosa to descending colon and descending colon was identified by the presence of straight colonic lumen and affirmed by an independent observer simultaneously.	1 hour
patients' pain score	patients' discomfort will be assessed by a 10-cm visual analog scale, in which a score of 0 denoted no pain and a score of 10 denoted unbearable pain	3 hour
patients' acceptance to unsedated or sedated colonoscopy in the future screening or examination	when colonoscopy insertion is completed, patients will be asked whether they would accept similar unsedated or sedated colonoscopy in the future screening or examination	3 hour

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: No.85 Hospital, Changning, Shanghai, China

Publications and helpful links

General Publications

• Willcock H, Gold DM. Supine Colonoscopy: An Advantage over Left Lateral in Synchronous Proctological Surgery. J Laparoendosc Adv Surg Tech A. 2016 Jun;26(6):475-7. doi: 10.1089/lap.2015.0609. Epub 2016 Mar 16.
• Waye JD, Yessayan SA, Lewis BS, Fabry TL. The technique of abdominal pressure in total colonoscopy. Gastrointest Endosc. 1991 Mar-Apr;37(2):147-51. doi: 10.1016/s0016-5107(91)70673-1.
• Zhao S, Yang X, Meng Q, Wang S, Fang J, Qian W, Xia T, Pan P, Wang Z, Gu L, Chang X, Zou D, Li Z, Bai Y. Impact of the supine position versus left horizontal position on colonoscopy insertion: a 2-center, randomized controlled trial. Gastrointest Endosc. 2019 Jun;89(6):1193-1201.e1. doi: 10.1016/j.gie.2019.01.009. Epub 2019 Jan 18.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: September 17, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: position-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No