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Two or Six cm From Pylorus at Laparoscopic Sleeve Gastrectomy

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ClinicalTrials.gov Identifier: NCT01784510
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : February 6, 2013
Sponsor:
Information provided by (Responsible Party):
Ahmed Abdel-Raouf El-Geidie, Mansoura University

Tracking Information
First Submitted Date  ICMJE February 2, 2013
First Posted Date  ICMJE February 6, 2013
Last Update Posted Date February 6, 2013
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
weight loss [ Time Frame: 12 months postoperative ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two or Six cm From Pylorus at Laparoscopic Sleeve Gastrectomy
Official Title  ICMJE Not Provided
Brief Summary Randomized controlled trial comparing between two technique of laparoscopic sleeve gastrectomy for treatment of morbid obesity. In the first technique the investigators started dissection of gastrocolic ligament 6 cm from pylorus and in the second one the distance was only 2 cm. The main primary outcome measure was weight loss.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE Morbid Obesity
Intervention  ICMJE Procedure: distance of dissection of gastrocolic ligament from pylorus
Study Arms  ICMJE
  • Active Comparator: 2 cm
    Intervention: Procedure: distance of dissection of gastrocolic ligament from pylorus
  • Experimental: 6 cm
    Intervention: Procedure: distance of dissection of gastrocolic ligament from pylorus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2013)
73
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • morbid obesity with body mass index more than 40 or 35 with at least one comorbidity

Exclusion Criteria:

  • extreme of age less than 18 or over 65 years contraindications to laparoscopy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01784510
Other Study ID Numbers  ICMJE 3696
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmed Abdel-Raouf El-Geidie, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mansoura University
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP