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OpenTrials
Completed

NCT Number: NCT03337217

Colonoscopy in the Prone Position for Patients With BMI Greater Than 30

In the United States, colonoscopy has become the most commonly used screening test for colorectal cancer. Colonoscopy is typically performed with the patient starting in the left lateral decubitus position, however there is little data to support this practice and starting position is variable amongst individual gastroenterology physicians.

The investigators plan to randomize patients with Body Mass Index >30 that are presenting to the University of Virginia for colonoscopy to either the prone or left lateral decubitus position. The investigators will then record and compare cecal intubation times as well as amount of sedation used and complications to help determine which position is superior for this patient population.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

About this study

Patients that have been scheduled for colonoscopy will undergo chart review. Patients who meet inclusion criteria will be invited to participate at the time consent is obtained for the colonoscopy. Participants will then be randomized to one of two colonoscopy starting positions.

After randomization, patients will begin the colonoscopy in either the prone position or left lateral decubitus position.

It is common practice to re-position the patient during endoscopy (including supine and prone positions) and some endoscopists commonly employ prone starting position for obese patients, although there is no estimate in the literature as to the prevalence of this practice.

No additional interventions will be performed for research purposes. During the colonoscopy, the endoscopist will be allowed, as usual, to adjust patient position as needed to complete the procedure. Cecal intubation time, amount of sedation used, and any intra-procedural complications (hypoxia, hypotension, etc) will be recorded for data analysis. This information is standardly recorded in the procedure report in the patient's medical record. The study will not affect any interventions performed during the colonoscopy such as polyp removal or biopsies as, clinically indicated. Per endoscopy unit protocol, patients will be monitored in the recovery area and discharged home with supervision. The study requires no further direct patient interaction after the colonoscopy is completed. Charts will be reviewed at 30 days to assess for any delayed and unexpected complications.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI >30
  • Undergoing screening or diagnostic colonoscopy with conscious sedation

Exclusion criteria

  • Pregnant women (self reported).
  • Cognitively impaired patients
  • History of colonic resection
  • Cannot lay in prone position
  • History of colon malignancy
  • Procedure aborted due to inadequate bowel prep
  • Severe pulmonary problems (including baseline oxygen use)
  • Inability to provide consent for themselves

Treatment and study plan

Position during colonoscopy

Procedure

Position during colonoscopy

Primary outcomes

  1. Cecal intubation time measured in seconds

    Time frame: Measured once during colonoscopy.

    Time to advance the colonoscope to the cecum during colonoscopy.

Secondary outcomes

  1. Milligrams of sedative used for sedation

    Time frame: Measured once at the completion of the colonoscopy.

    Amount of fentanyl and midazolam needed for adequate sedation.

  2. Technical difficulty of procedure (questionnaire)

    Time frame: Recorded once at the completion of the colonoscopy.

    Measure of subjective sense of difficulty as perceived by the endoscopist.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Colonoscopy in the Prone Position for Patients With BMI Greater Than 30 Is Superior to Standard Left Lateral Decubitus Position

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2017
Registry last updated
Jun 12, 2019

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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