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Left Lateral Tilt-down Position During Colonoscopy Insertion

N

Naval Military Medical University

Status

Completed

Conditions

Colonoscopy Insertion

Treatments

Procedure: left lateral tilt-down position
Procedure: left lateral horizontal position

Study type

Interventional

Funder types

Other

Identifiers

NCT02842489
body position-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

258 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

258 participants in 2 patient groups

left lateral tilt-down position
Experimental group
Description:
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
Treatment:
Procedure: left lateral tilt-down position
left lateral horizontal body position
Active Comparator group
Description:
patients will be positioned on the left lateral horizontal position during colonoscopy insertion
Treatment:
Procedure: left lateral horizontal position

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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