DiverticulosisCTDTTIENCT01815671
Evaluate the Safety and Diagnostic Advantages of Tilt Down Verses Standard Horizontal Colonoscopy Positioning
A study testing colonoscopy in the lateral horizontal position in people with Diverticulosis, run by Specialists in Gastroenterology, LLC at 1 site in United States.
Trial summary
A tortuous sigmoid colon makes colonoscopy difficult. The purpose of this study was to systematically evaluate the diagnostic utility and incidence of adverse events in women using standard horizontal compared to lateral tilt down positioning for colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Diverticulosis
- What is being tested?
- colonoscopy in the lateral horizontal position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ability to understand and sign consent
- women and men with a BMI (body mass index) <35 kg/m2
- age 18 - 90 years
- no liquids by mouth for ≥2 hours
- no solid food for ≥8 hours
Who cannot join
- inability to provide informed consent
- morbid obesity (BMI ≥35)
- pregnancy
- uncontrolled gastroesophageal reflux disease
- gastroparesis
- scleroderma
Show all 19Show fewer
- achalasia
- Crohn's disease
- ulcerative colitis
- history of a colon resection
- Parkinson's disease
- brain tumor
- multiple sclerosis
- ischemic optic neuropathy
- glaucoma
- active pulmonary infection
- liquid intake <2 hours
- solid food intake <8 hours prior to the procedure
- intra-procedure findings of a stricture resulting in an incomplete colonoscopy or Boston bowel preparation scores of <6
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Body Positioning for Colonoscopy in Women: Randomized, Study of Left Lateral Tilt Down Versus Left Lateral Horizontal Positioning
A tortuous sigmoid colon makes colonoscopy difficult. The purpose of this study was to systematically evaluate the diagnostic utility and incidence of adverse events in women using standard horizontal compared to lateral tilt down positioning for colonoscopy.
Read the detailed description
This was a prospective, randomized study. Subjects who provide informed consent and present to the offices of Specialists in Gastroenterology for colonoscopy will be randomized in a 1:1 distribution to either left lateral tilt down versus left lateral horizontal positioning to initiate colonoscopy.
Demographic data as well as routine information regarding the colonoscopy was filled out during or at the end of each procedure. In addition, the following parameters were assessed, and compared between groups:
- Occurrence of complications related or possibly related to the colonoscopy procedure
- Scope insertion time
- Pain during and after the procedure
The subjects' participation was limited to the duration of the colonoscopy, which is typically less than 60 min and a follow up by telephone 24 hours later to assess the occurrence of complications.
- Conditions
- Diverticulosis
- Being tested
- colonoscopy in the lateral horizontal position
- Keywords
- colonoscopy, technique, tilt, insertion, safety, efficacy
- Medical subject headings
- Diverticulum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopy in the lateral horizontal positionProcedure or surgery
colonoscopy in the lateral horizontal position with tilt down
| Study group | Role | What they receive |
|---|---|---|
| Lateral horizontal body position | Other | Subjects randomized to receive colonoscopy in the lateral horizontal position, This is the standard position. The other position - tilt down is the intervention Receives: Procedure: colonoscopy in the lateral horizontal position |
| Lateral tilt down body position | Other | Subjects randomized to receive colonoscopy in the lateral tilt down position Receives: Procedure: colonoscopy in the lateral horizontal position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure
The number of participants who experience adverse events which are related or possibly related to the colonoscopy procedure will be tallied in each treatment arm.
Measured: 24 hours
Secondary outcomes (2)
Time to Full Colonoscope Insertion
Measured: 30 minutes
Pain Related or Possibly Related to Colonoscopy Procedure
Visual Analogue Scale measured 0-4 with zero being no pain and 4 being most severe pain.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Increased number of oxygen desaturation in tilt down position
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiverticulosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Specialists in Gastroenterology, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonard B Weinstock, MD, Principal investigator, Specialists in Gastroenterology, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815671
- Sponsor's protocol ID
- BP-1
- Other IDs
- Leonard Weinstock, MD
- Acronym
- CTDTTIE
- Status last verified
- Feb 2014
- First submitted
- 18 Mar 2013
- Last updated
- 5 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Weinstock LB. Body positions for colonoscopy: value of Trendelenburg. Gastrointest Endosc. 2009 Jun;69(7):1409-10. doi: 10.1016/j.gie.2008.09.039. No abstract available.
PubMed 19481671
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Positioning for Colonoscopy in Women: Randomized, Study of Left Lateral Tilt Down Versus Left Lateral Horizontal Positioning
- ClinicalTrials.gov ID
- NCT01815671
- Acronym / sponsor ID
- CTDTTIE / BP-1
- Conditions
- Diverticulosis
- Keywords
- colonoscopy, technique, tilt, insertion, safety, efficacy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Increased number of oxygen desaturation in tilt down position
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Specialists in Gastroenterology, LLCUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Posted 5 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A tortuous sigmoid colon makes colonoscopy difficult. The purpose of this study was to systematically evaluate the diagnostic utility and incidence of adverse events in women using standard horizontal compared to lateral tilt down positioning for colonoscopy.
Detailed description
This was a prospective, randomized study. Subjects who provide informed consent and present to the offices of Specialists in Gastroenterology for colonoscopy will be randomized in a 1:1 distribution to either left lateral tilt down versus left lateral horizontal positioning to initiate colonoscopy.
Demographic data as well as routine information regarding the colonoscopy was filled out during or at the end of each procedure. In addition, the following parameters were assessed, and compared between groups:
- Occurrence of complications related or possibly related to the colonoscopy procedure
- Scope insertion time
- Pain during and after the procedure
The subjects' participation was limited to the duration of the colonoscopy, which is typically less than 60 min and a follow up by telephone 24 hours later to assess the occurrence of complications.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral horizontal body position | Other | Procedure: colonoscopy in the lateral horizontal positionSubjects randomized to receive colonoscopy in the lateral horizontal position, This is the standard position. The other position - tilt down is the intervention |
| Lateral tilt down body position | Other | Procedure: colonoscopy in the lateral horizontal positionSubjects randomized to receive colonoscopy in the lateral tilt down position |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ability to understand and sign consent
- women and men with a BMI (body mass index) <35 kg/m2
- age 18 - 90 years
- no liquids by mouth for ≥2 hours
- no solid food for ≥8 hours
Key exclusion criteria (19 listed)
- inability to provide informed consent
- morbid obesity (BMI ≥35)
- pregnancy
- uncontrolled gastroesophageal reflux disease
- gastroparesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopy in the lateral horizontal positioncolonoscopy in the lateral horizontal position with tilt down | Procedure or surgery | Lateral horizontal body position, Lateral tilt down body position |
Primary outcome
Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure
Time frame: 24 hours
The number of participants who experience adverse events which are related or possibly related to the colonoscopy procedure will be tallied in each treatment arm.
2 secondary outcomes
Time to Full Colonoscope Insertion
Time frame: 30 minutes
Pain Related or Possibly Related to Colonoscopy Procedure
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19481671Weinstock LB. Body positions for colonoscopy: value of Trendelenburg. Gastrointest Endosc. 2009 Jun;69(7):1409-10. doi: 10.1016/j.gie.2008.09.039. No abstract available.
Related trials for Diverticulosis
Enrolling by invitation
Transvaginal Diverticulum Wall Filling and Coverage Technique for Treating Female Circumferential Urethral Diverticulum
Circumferential Female Urethral Diverticulum
Not yet recruitingObservational study
Analysis of the Role of the Microbiota in Diverticular Disease
Diverticular Disease of Colon, Acute Diverticulitis
Recruiting
Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women
Isthmocele, Cesarean Scar Diverticula
RecruitingObservational study
Advanced Endo-therapeutic Procedure : Registry-based Observational Study
Zenker Diverticulum, Polyp of Colon
RecruitingObservational study
Clinical Value of Saline Infusion Sonohysterography in the Assessment of Cesarean Scar Defects
Infertility
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.
Leonard B Weinstock, MD principal investigator
Specialists in Gastroenterology, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colonoscopy in the lateral horizontal position in people with Diverticulosis, run by Specialists in Gastroenterology, LLC 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 5 inclusion and 19 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: stopped early, as of the sponsor's last update on 5 Feb 2014. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure (time frame: 24 hours). 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 NCT01815671, which also lists 1 linked publication.
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 5 Feb 2014.