NCT02519686

Brief Summary

The purpose of this study is to determine if the trendelenberg (TD) position (position in procedures that involves placing the patient at an angle so that their head is lower than their feet on the procedure bed) in select patients undergoing colonoscopy is superior than the left lateral (LL) position (patient laying on their side, traditionally used for colonoscopies) in terms of decreasing time necessary to pass the colonoscope through the left colon, and decreasing the difficulty of the procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

July 13, 2015

Last Update Submit

November 1, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cecal insertion time

    The time from scope insertion to the cecum

    intraoperaive

Study Arms (2)

Trendelenburg position maneuver

Trendelenburg (TD) positioning (supine with head tilt-down) is used in abdominal and gynecological surgery as well as during colonoscopy to allow better access to the pelvic organs, as gravity pulls the bowel out of the pelvic cavity and the rectosigmoid angle straightens.

Left lateral position maneuver

Left Lateral (LL) position (patient laying on their side, traditionally used for colonoscopies)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults

You may qualify if:

  • Personal history of pelvic surgery
  • Diverticulosis, identified by patient report or review of previous colonoscopy or imaging studies.
  • BMI \< 25.

You may not qualify if:

  • Patients who have undergone colonic resection
  • Patients with glaucoma
  • Patients with uncontrolled acid reflux disease or active nausea/vomiting.
  • Patients who are unwilling or unable to consent.
  • BMI \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

  • Thorlakson RH, Thorlakson TK. The lithotomy-Trendelenburg position for restorative resection by stapling and abdominoperineal excision of the rectum. Can J Surg. 1984 May;27(3):246-7.

    PMID: 6372977BACKGROUND
  • Ozcan MS, Praetel C, Bhatti MT, Gravenstein N, Mahla ME, Seubert CN. The effect of body inclination during prone positioning on intraocular pressure in awake volunteers: a comparison of two operating tables. Anesth Analg. 2004 Oct;99(4):1152-1158. doi: 10.1213/01.ANE.0000130851.37039.50.

    PMID: 15385367BACKGROUND
  • Shah HA, Paszat LF, Saskin R, Stukel TA, Rabeneck L. Factors associated with incomplete colonoscopy: a population-based study. Gastroenterology. 2007 Jun;132(7):2297-303. doi: 10.1053/j.gastro.2007.03.032. Epub 2007 Mar 21.

    PMID: 17570204BACKGROUND
  • Weinstock LB, Early DS. Colonoscopy in the tilt-down position. Gastrointest Endosc. 2014 Oct;80(4):746. doi: 10.1016/j.gie.2014.05.328. No abstract available.

    PMID: 25220519BACKGROUND

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Dayna S Early, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2015

First Posted

August 11, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations