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

Bidirectional Endoscopy Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01491126
• Other study ID #: SHEBA-11-8951-DC-CTIL
• Status: Unknown status
• Phase: N/A
• First received: December 11, 2011
• Last updated: February 24, 2014
• Start date: January 2012
• Est. completion date: March 2015

Study information

• Verified date: February 2014
• Source: Sheba Medical Center
• Contact: Dan Carter, MD
• Phone: 972-3-5302197
• Email: carterd[@]zahav.net.il
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Secondary endpoints will rate of detection of significant pathologies, total time of procedure, examinee's tolerance, time to recovery and examinee's satisfaction.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 170
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bidirectional Endoscopy

Locations

Country	Name	City	State
Israel	Sheba medical center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of mephridine and midazolam	Dose of analgestices used in order to achive concious sedation	1 year
Secondary	Time to recovery	Time to full recovery and release after endoscopies	1 year
Secondary	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	1 year