Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Left Lateral Tilt-down Position During Colonoscopy Insertion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842489
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

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.

Condition or disease Intervention/treatment Phase
Colonoscopy Insertion Procedure: left lateral tilt-down position Procedure: left lateral horizontal position Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Left Lateral Tilt-down Position During Colonoscopy Insertion: a Randomized Controlled Trial
Study Start Date : June 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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




Primary Outcome Measures :
  1. cecal colon insertion time [ Time Frame: This outcome is measured when cecal colon is intubated during a colonoscopy ]

Secondary Outcome Measures :
  1. patients' discomfort of colonoscopy [ Time Frame: 2 hours ]
    patients' discomfort will be assessed by a 10-cm visual analog scale

  2. endoscopists' perception of difficulty of colonoscopy [ Time Frame: 2 hours ]
    difficulty of colonoscopy will be assessed by a 10-cm visual analog scale

  3. decending insertion time [ Time Frame: This outcome is measured when decending colon is intubated during a colonoscopy ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842489


Locations
Layout table for location information
China
Changhai Hospital, Second Military Medical University
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Investigators
Layout table for investigator information
Principal Investigator: Li Zhaoshen, MD Changhai Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept and Digestive Endoscopy Center, Changhai Hospital
ClinicalTrials.gov Identifier: NCT02842489    
Other Study ID Numbers: body position-1
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Keywords provided by Zhaoshen Li, Changhai Hospital:
colonoscopy insertion
tilt-down position