Bidirectional EndoscopyNCT01491126
Single Center Open Prospective Study for the Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy
An observational study of Bidirectional Endoscopy, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The investigators study aim is to determine whether there is a any advantage in starting with upper or lower endoscopy. The main study objective will be the amount of analgesia needed for sustaining the examinee's comfort during the exams. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bidirectional Endoscopy
- How many people
- 170 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Mar 2015
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will include sequential examinees undergoing bidirectional endoscopy. The decision to perform same day sequential bidirectional endoscopy is of the examinee's caring gastroenterologist, and not part of the study. Only examinees > 18 years will be eligible.
Who may be able to join
- Age> 18
- Same day bidirectional endoscopy
Who cannot join
- Prior failed endoscopy.
- Any major complication during previous endoscopy.
- Difficulty in communication with the patients.
- Psychiatric disease or mental retardation.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators study aim is to determine whether there is a any advantage in starting with upper or lower endoscopy. The main study objective will be the amount of analgesia needed for sustaining the examinee's comfort during the exams. Secondary endpoints will rate of detection of significant pathologies, total time of procedure, examinee's tolerance, time to recovery and examinee's satisfaction.
- Conditions
- Bidirectional Endoscopy
- Keywords
- Gastroscopy, Colonoscopy, Anesthesia, Recovery
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 |
|---|---|---|
| examinees undergoing bidirectional endoscopy | Study population will include sequential examinees undergoing bidirectional endoscopy, age> 18 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of mephridine and midazolam
Dose of analgestices used in order to achive concious sedation
Measured: 1 year
Secondary outcomes (2)
Time to recovery
Time to full recovery and release after endoscopies
Measured: 1 year
Rate of significant findings
Rate of significant findings: colonoscopy: polyps, carcinoma, inflammation, diverticuli, A-V malformations Upper endoscopy: Barret's esophagus, severe esophagitis, gastritis, peptic ulcer disease, polyps and space occupying lesions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bidirectional EndoscopyStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Dan Carter, Gastroenterologist, Sheba Medical Center
- Investigators
- Dan Carter, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491126
- Sponsor's protocol ID
- SHEBA-11-8951-DC-CTIL
- Status last verified
- Feb 2014
- First submitted
- 11 Dec 2011
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cho JH, Kim JH, Lee YC, Song SY, Lee SK. Comparison of procedural sequences in same-day bidirectional endoscopy without benzodiazepine and propofol sedation: starting at the bottom or the top. J Gastroenterol Hepatol. 2010 May;25(5):899-904. doi: 10.1111/j.1440-1746.2009.06157.x.
PubMed 20546443Urquhart J, Eisen G, Faigel DO, Mattek N, Holub J, Lieberman DA. A closer look at same-day bidirectional endoscopy. Gastrointest Endosc. 2009 Feb;69(2):271-7. doi: 10.1016/j.gie.2008.04.063. Epub 2008 Aug 23.
PubMed 18725159Hardwick RH, Armstrong CP. Synchronous upper and lower gastrointestinal endoscopy is an effective method of investigating iron-deficiency anaemia. Br J Surg. 1997 Dec;84(12):1725-8.
PubMed 9448626
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Open Prospective Study for the Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy
- ClinicalTrials.gov ID
- NCT01491126
- Acronym / sponsor ID
- SHEBA-11-8951-DC-CTIL
- Conditions
- Bidirectional Endoscopy
- Keywords
- Gastroscopy, Colonoscopy, Anesthesia, Recovery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 13 Dec 2011 (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 investigators study aim is to determine whether there is a any advantage in starting with upper or lower endoscopy. The main study objective will be the amount of analgesia needed for sustaining the examinee's comfort during the exams. Secondary endpoints will rate of detection of significant pathologies, total time of procedure, examinee's tolerance, time to recovery and examinee's satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| examinees undergoing bidirectional endoscopy | – | –Study population will include sequential examinees undergoing bidirectional endoscopy, age> 18 years |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include sequential examinees undergoing bidirectional endoscopy. The decision to perform same day sequential bidirectional endoscopy is of the examinee's caring gastroenterologist, and not part of the study. Only examinees > 18 years will be eligible.
Key inclusion criteria (2 listed)
- Age> 18
- Same day bidirectional endoscopy
Key exclusion criteria (4 listed)
- Prior failed endoscopy.
- Any major complication during previous endoscopy.
- Difficulty in communication with the patients.
- Psychiatric disease or mental retardation.
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
Dose of mephridine and midazolam
Time frame: 1 year
Dose of analgestices used in order to achive concious sedation
2 secondary outcomes
Time to recovery
Time frame: 1 year
Rate of significant findings
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
- Background: PubMed 20546443Cho JH, Kim JH, Lee YC, Song SY, Lee SK. Comparison of procedural sequences in same-day bidirectional endoscopy without benzodiazepine and propofol sedation: starting at the bottom or the top. J Gastroenterol Hepatol. 2010 May;25(5):899-904. doi: 10.1111/j.1440-1746.2009.06157.x.
- Background: PubMed 18725159Urquhart J, Eisen G, Faigel DO, Mattek N, Holub J, Lieberman DA. A closer look at same-day bidirectional endoscopy. Gastrointest Endosc. 2009 Feb;69(2):271-7. doi: 10.1016/j.gie.2008.04.063. Epub 2008 Aug 23.
- Background: PubMed 9448626Hardwick RH, Armstrong CP. Synchronous upper and lower gastrointestinal endoscopy is an effective method of investigating iron-deficiency anaemia. Br J Surg. 1997 Dec;84(12):1725-8.
Related trials for Bidirectional Endoscopy
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Efficacy and Safety of Fospropofol for Same-day Bidirectional Endoscopy in Elderly Patients
Elderly Patients
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.
Dan Carter, MD principal investigator
Sheba Medical Center
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 Bidirectional Endoscopy, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Carter, MD (972-3-5302197, carterd@zahav.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of mephridine and midazolam (time frame: 1 year). 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 NCT01491126, which also lists 3 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 25 Feb 2014.