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Clinical Trials/NCT03289442
NCT03289442CompletedNot Applicable

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

Changhai Hospital1 site in 1 country347 target enrollmentStarted: August 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
347
Locations
1
Primary Endpoint
cecal intubation time

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •aged between 18-75 years
  • •underwent screening, surveillance, and diagnostic colonoscopy

Exclusion Criteria

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

Arms & Interventions

supine position group

Experimental

Intervention: supine position (Procedure)

left lateral position

No Intervention

Outcomes

Primary Outcomes

cecal intubation time

Time Frame: 2 hour

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.

Secondary Outcomes

  • patients' acceptance to unsedated or sedated colonoscopy in the future screening or examination(3 hour)
  • patients' pain score(3 hour)
  • descending colon intubation time(1 hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhaoshen Li

Director, Head of Department of Gastroenterology, Principal Investigator, Clinical Professor

Changhai Hospital

Study Sites (1)

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