Colonic DiseasesNCT02519686
Trendelenberg Versus Left Lateral Position for Colonoscopy
An observational study of Colonic Diseases, run by Washington University School of Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Colonic Diseases
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adults
Who may be able to join
- Personal history of pelvic surgery
- Diverticulosis, identified by patient report or review of previous colonoscopy or imaging studies.
- BMI < 25.
Who cannot join
- Patients who do not meet inclusion criteria.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St Louis School of Medicine
St Louis, Missouri, 63110
About this study
Official title: The Impact of Trendelenberg Positioning as Compared to Left Lateral Positioning on Ease of Colonoscope Insertion During Colonoscopy
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.
Read the 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.
- Conditions
- Colonic Diseases
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal insertion time
The time from scope insertion to the cecum
Measured: intraoperaive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colonic DiseasesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dayna S Early, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519686
- Sponsor's protocol ID
- 201504136
- Status last verified
- Nov 2016
- First submitted
- 13 Jul 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 6372977Ozcan 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.
PubMed 15385367Shah 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.
PubMed 17570204Weinstock 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.
PubMed 25220519
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Trendelenberg Positioning as Compared to Left Lateral Positioning on Ease of Colonoscope Insertion During Colonoscopy
- ClinicalTrials.gov ID
- NCT02519686
- Acronym / sponsor ID
- 201504136
- Conditions
- Colonic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults
Key inclusion criteria (3 listed)
- Personal history of pelvic surgery
- Diverticulosis, identified by patient report or review of previous colonoscopy or imaging studies.
- BMI < 25.
Key exclusion criteria (6 listed)
- Patients who do not meet inclusion criteria.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cecal insertion time
Time frame: intraoperaive
The time from scope insertion to the cecum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Background: PubMed 6372977Thorlakson 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.
- Background: PubMed 15385367Ozcan 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.
- Background: PubMed 17570204Shah 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.
- Background: PubMed 25220519Weinstock 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dayna S Early, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Diseases, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cecal insertion time (time frame: intraoperaive). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02519686, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.