The Role of Left Lateral Tilt-down Position During Colonoscopy Insertion: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Changhai Hospital
- Enrollment
- 258
- Locations
- 1
- Primary Endpoint
- cecal colon insertion time
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients whose age is between 18-75
- •Patients who have indications for diagnostic or therapeutic colonoscopy .
- •Patients who have signed inform consent form
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: left lateral tilt-down position (Procedure)
left lateral horizontal body position
patients will be positioned on the left lateral horizontal position during colonoscopy insertion
Intervention: left lateral horizontal position (Procedure)
Outcomes
Primary Outcomes
cecal colon insertion time
Time Frame: This outcome is measured when cecal colon is intubated during a colonoscopy
Secondary Outcomes
- decending insertion time(This outcome is measured when decending colon is intubated during a colonoscopy)
- patients' discomfort of colonoscopy(2 hours)
- endoscopists' perception of difficulty of colonoscopy(2 hours)
Investigators
Zhaoshen Li
Director of Gastroenterology Dept and Digestive Endoscopy Center
Changhai Hospital