Single Center Open Prospective Study for the Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy

NCT ID: NCT01491126

Last Updated: 2014-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bidirectional Endoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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examinees undergoing bidirectional endoscopy

Study population will include sequential examinees undergoing bidirectional endoscopy, age\> 18 years

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age\> 18
* Same day bidirectional endoscopy

Exclusion Criteria

* Prior failed endoscopy.
* Any major complication during previous endoscopy.
* Difficulty in communication with the patients.
* Psychiatric disease or mental retardation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Dan Carter, Gastroenterologist

Gasteroenterologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Carter, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba medical center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Central Contacts

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Dan Carter, MD

Role: CONTACT

972-3-5302197

Eitan Bardan, MD

Role: CONTACT

972-52-6667161

References

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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.

Reference Type BACKGROUND
PMID: 20546443 (View on PubMed)

Urquhart 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.

Reference Type BACKGROUND
PMID: 18725159 (View on PubMed)

Hardwick 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.

Reference Type BACKGROUND
PMID: 9448626 (View on PubMed)

Other Identifiers

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SHEBA-11-8951-DC-CTIL

Identifier Type: -

Identifier Source: org_study_id

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