Trendelenberg Versus Left Lateral Position for Colonoscopy

Colonic Diseases Clinical Trial

Official title:

The Impact of Trendelenberg Positioning as Compared to Left Lateral Positioning on Ease of Colonoscope Insertion During Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519686
• Other study ID #: 201504136
• Status: Completed
• Phase: N/A
• First received: July 13, 2015
• Last updated: November 1, 2016
• Start date: July 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Diseases

Locations

Country	Name	City	State
United States	Washington University in St Louis School of Medicine	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (4)

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):1152-8, table of contents. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cecal insertion time	The time from scope insertion to the cecum	intraoperaive	Yes