Clinical trial NCT02519686: Trendelenberg Versus Left Lateral Position for Colonoscopy
Official title: The Impact of Trendelenberg Positioning as Compared to Left Lateral Positioning on Ease of Colonoscope Insertion During Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Diseases
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults

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.

Detailed description: The colonoscopists will be asked to rate their prediction of difficulty of the procedure prior to the colonoscopy and to rate the ease of procedure after the colonoscopy. The clinical experience of the study investigators is that TD positioning is superior to LL positioning in patients with risk factors for having a difficult colonoscopy (thin women; those with diverticulosis- small bulging pouches present in the colon; or prior pelvic surgery).

Patients with risk factors for difficult colonoscopy will be randomized to undergo colonoscopy while positioned in the TD position or the LL position during advancement of the colonoscope through the sigmoid colon. The sigmoid colon is a section of the colon, proximal to the rectum, that is curved. The sigmoid colon is a normal component of GI tract anatomy, although due to it's shape, especially with the risk factors listed previously; can cause challenges to inserting the colonoscope.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients who do not meet inclusion criteria.
2. Patients who have undergone colonic resection
3. Patients with glaucoma
4. Patients with uncontrolled acid reflux disease or active nausea/vomiting.
5. Patients who are unwilling or unable to consent.
6. BMI \> 30

Primary outcomes:
measure: Cecal insertion time
timeFrame: intraoperaive
Secondary outcomes:
Other outcomes:
Locations:
city: St Louis
country: United States
facility: Washington University in St Louis School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Dayna S Early, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.