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OpenTrials
Completed

NCT Number: NCT02842489

Left Lateral Tilt-down Position During Colonoscopy Insertion

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

left lateral tilt-down position

Procedure

patients will be positioned on their left side and at an angle of 20 degree

left lateral horizontal position

Procedure

patients will be horizontally positioned on their left side

Primary outcomes

  1. cecal colon insertion time

    Time frame: This outcome is measured when cecal colon is intubated during a colonoscopy

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

The Role of Left Lateral Tilt-down Position During Colonoscopy Insertion: a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 25, 2016
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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