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Biliary Limb as a Percentage From the Small Intestine Rather Than Fixed Length in Loop Bypass Surgery for Morbid Obesity

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ClinicalTrials.gov Identifier: NCT04826055
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Alaa Mstafa Hassan Sewefy, Minia University

Study Description
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Brief Summary:
in all loop bypass bariatric procedure (mini gastric bypass & single anastomosis sleeve jejunal bypass), biliary limb is fixed length. we do it as a percentage from total small intestine length rather than fixed length

Condition or disease Intervention/treatment Phase
Obesity, Morbid Other: biliary limb as fixed length Other: biliary limb as a percentage from small intestine length Not Applicable

Detailed Description:
in all loop bypass bariatric procedure (mini gastric bypass & single anastomosis sleeve jejunal bypass), biliary limb is fixed length we count the length of small intestine and do it as a percentage from total small intestine length rather than fixed length
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: tp Make the Length of the Biliary Limb as a Percentage From the Small Intestine Rather Than Fixed Length in Loop Bypass Surgery for Morbid Obesity
Actual Study Start Date : March 25, 2021
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : April 20, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: loop bypass with fixed biliary limb length
in all loop bypass procedures we will don't count the total length of small intestine and make the biliary limb as a fixed from total small intestine length as mentioned in literature
 Other: biliary limb as fixed length
n all loop bypass procedures we will don't count the total length of small intestine and make the biliary limb as a fixed from total small intestine length as mentioned in literature
Experimental: loop bypass with a biliary limb is a percentage of the small intestine
in all loop bypass procedures we count the total length of small intestine and make the biliary limb as a percentage from total small intestine length rather than fixed length
 Other: biliary limb as a percentage from small intestine length
in all loop bypass procedures we count the total length of small intestine and make the biliary limb as a percentage from total small intestine length rather than fixed length


Outcome Measures
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Primary Outcome Measures :
  1. effect on weight loss [ Time Frame: one year ]
    the effect on weight loss

  2. effect on nutritional deficiency [ Time Frame: 1 year ]
    the effect on nutritional deficiency


Secondary Outcome Measures :
  1. operative time [ Time Frame: 6 hours ]
    operative time from skin incision to skin closure

  2. effect on obesity comorbidities [ Time Frame: 1 year ]
    the effect on improvement of obesity related comorbidities

  3. early complications [ Time Frame: 30 days ]
    the operative and postoperative 30 days complications

  4. late complications [ Time Frame: 1 year ]
    the late reported complications


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • obese patients with BMI more than 40 or more than 35 with comorbidity
  • patients fit for laparoscopic surgery
  • give approval to share in the study

Exclusion Criteria:

  • patients refused to share in the study
  • patients unfit for surgery
  • patients aged less than 18 and older than 50
  • patients with BMI less than 35
  • patient with previous upper abdominal surgery either for obesity or other diseases
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04826055


Contacts
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Contact: alaa sewefy +201006448805 sewafy@yahoo.co.uk

Locations
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Egypt
Faculty of medicine Recruiting
Minya, Egypt, 61511
Contact: Alaa M Sewefy, MD    +201006448805    sewafy@yahoo.co.uk   
Contact: M         
Sponsors and Collaborators
Minia University
More Information
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Responsible Party: Alaa Mstafa Hassan Sewefy, Assistant professor and consultant of general surgery, Minia University
ClinicalTrials.gov Identifier: NCT04826055    
Other Study ID Numbers: fac.med 21.17
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alaa Mstafa Hassan Sewefy, Minia University:
biliary limb length in bypass bariatric surgery
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
 Nutrition Disorders
Overweight
Body Weight