Study Results
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Basic Information
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RECRUITING
NA
234 participants
INTERVENTIONAL
2023-03-15
2028-04-15
Brief Summary
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Detailed Description
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The hypotheses are that laparoscopic conversion from LSG to Single anastomosis duodeno-ileal bypass (SADI-S), Roux-en-Y gastric bypass (RYGB), or one anastomosis gastric bypass (OAGB) will provide a new significant weight loss, improvement in obesity-related health problems and provide no nutritional deficiency in all cases.
Since the three types of procedures have other anatomical presentations, whereby these is not well tested next to each other in a blinded, controlled setting for the patient, this study is designed to discover if the procedures are superior to each other or not and what the best outcome is for the patient.
A sample size is calculated and with a medium effect size of 0.5 corresponds to a mean difference in %EBMIL between SADI-S, RYGB, and OAGB of at least 10%. Using a power of 0.8 with an alpha of 0.05 resulted in a sample size of 64 patients per group.
Considering a possible loss of patients to follow-up, an additional 20% increase in sample size was included per group, resulting in a minimum of 78 patients per group.
(Total of 3 groups together of 234 patients).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RYGB procedure arm 1
After failed sleeve, the patients will get a revisional procedure. The RYGB
revision surgery
revision procedure after failed sleeve gastrectomy
OAGB procedure arm 2
After failed sleeve, the patients will get a revisional procedure. The OAGB
revision surgery
revision procedure after failed sleeve gastrectomy
SADI-S procedure arm 3
After failed sleeve, the patients will get a revisional procedure. The SADI-S
revision surgery
revision procedure after failed sleeve gastrectomy
Interventions
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revision surgery
revision procedure after failed sleeve gastrectomy
Eligibility Criteria
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Inclusion Criteria
* Weight regain
* defined as any increase in weight above the nadir as reported by the patient
* BMI at the time of revisional surgery was around 45 kg/m2
* weight regain was defined as an increase in BMI after bariatric surgery to exceed 35
* With or without Gastroesophageal reflux disease (GERD) grade A and B o Patients with grade C or higher GERD, according to the Los Angeles (LA) classification \[7\] will be excluded from the study
Exclusion Criteria
* Cannot give of sign informed consent
18 Years
60 Years
ALL
Yes
Sponsors
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General Committee of Teaching Hospitals and Institutes, Egypt
OTHER_GOV
Responsible Party
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Mohamed Hany Ashour
ass professor
Principal Investigators
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Mohamed Ashour, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alexandria
Locations
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Madina Women's Hospital
Alexandria, Alexandria Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Guan B, Chong TH, Peng J, Chen Y, Wang C, Yang J. Mid-long-term Revisional Surgery After Sleeve Gastrectomy: a Systematic Review and Meta-analysis. Obes Surg. 2019 Jun;29(6):1965-1975. doi: 10.1007/s11695-019-03842-3.
Lazzati A, Bechet S, Jouma S, Paolino L, Jung C. Revision surgery after sleeve gastrectomy: a nationwide study with 10 years of follow-up. Surg Obes Relat Dis. 2020 Oct;16(10):1497-1504. doi: 10.1016/j.soard.2020.05.021. Epub 2020 May 29.
Clapp B, Wynn M, Martyn C, Foster C, O'Dell M, Tyroch A. Long term (7 or more years) outcomes of the sleeve gastrectomy: a meta-analysis. Surg Obes Relat Dis. 2018 Jun;14(6):741-747. doi: 10.1016/j.soard.2018.02.027. Epub 2018 Mar 6.
Parmar CD, Gan J, Stier C, Dong Z, Chiappetta S, El-Kadre L, Bashah MM, Wang C, Sakran N. One Anastomosis/Mini Gastric Bypass (OAGB-MGB) as revisional bariatric surgery after failed primary adjustable gastric band (LAGB) and sleeve gastrectomy (SG): A systematic review of 1075 patients. Int J Surg. 2020 Sep;81:32-38. doi: 10.1016/j.ijsu.2020.07.007. Epub 2020 Jul 29.
Chiappetta S, Stier C, Scheffel O, Squillante S, Weiner RA. Mini/One Anastomosis Gastric Bypass Versus Roux-en-Y Gastric Bypass as a Second Step Procedure After Sleeve Gastrectomy-a Retrospective Cohort Study. Obes Surg. 2019 Mar;29(3):819-827. doi: 10.1007/s11695-018-03629-y.
Angrisani L, Santonicola A, Iovino P, Ramos A, Shikora S, Kow L. Bariatric Surgery Survey 2018: Similarities and Disparities Among the 5 IFSO Chapters. Obes Surg. 2021 May;31(5):1937-1948. doi: 10.1007/s11695-020-05207-7. Epub 2021 Jan 12.
Sami S, Ragunath K. The Los Angeles Classification of Gastroesophageal Reflux Disease. Video Journal and Encyclopedia of GI Endoscopy. 2013;1:103-4.
Other Identifiers
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RCT-revision-3arms
Identifier Type: -
Identifier Source: org_study_id
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