Evaluation the efficacy of anterior cruroplasty versus posterior cruroplasty in improvement of Gastroesophageal reflux disease (GERD)after One Anastomosis Gastric Bypass (OAGB)
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Protocol summary
Clinical trial, with parallel groups, single-blind, randomized, on 120 patients
Clinical trial, with parallel groups, single-blind, randomized, on 90 patients
Clinical trial, with parallel groups, single-blind, randomized, on 12090 patients
کارآزمایی بالینی ، با گروه های موازی ، یک سویه کور ، تصادفی شده، بر روی 120 بیمار
کارآزمایی بالینی، با گروه های موازی، یک سویه کور، تصادفی شده، بر روی 90 بیمار
کارآزمایی بالینی، با گروه های موازی، یک سویه کور، تصادفی شده، بر روی 12090 بیمار
Rasool-e Akram, Modarres, and Firouzgar hospitals in Tehran
This trial will be conducted on 90 patients in Rasool-e Akram hospital. Patients will be blind.
This trial will be conducted on 90 patients in Rasool-e Akram, Modarres, and Firouzgar hospitals in Tehran hospital. Patients will be blind.
بیمارستان رسول، مدرس، و فیروزگر تهران
این کارآزمایی بر روی 90 بیمار در بیمارستان رسول اکرم انجام خواهد گرفت. بیماران کور خواهند بود.
این کارآزمایی بر روی 90 بیمار در بیمارستان رسول، مدرس، و فیروزگر تهران اکرم انجام خواهد گرفت. بیماران کور خواهند بود.
Inclusion criteria were: 40
Inclusion criteria: 40
Inclusion criteria were: 40
معیارهای ورود عبارتند از:
رضایت به شرکت در مطالعه،
BMI زیر ۵۰ و بالای ۴۰،
سن ۱۸ تا ۶۵،
عمل اولیه،
جراحی OAGB،
طول بازو ۱۵۰،
طول آناستوموز ۴ سانت،
وجود ریفلاکس کلینیکی قبل عمل و در اندوسکوپی ریفلاکس گریدA, B, C،
و وجود هرنی هیاتال با هر اندازه. معیارهای عدم ورود عبارتند از ریسک بالای بیهوشی بعد از مشاوره قلب و ریه،
تشخیص جراح مبنی بر ریسک بالای جراحی،
عدم سلامت روان: مشکل جدی روانی شامل سایکوز و افسردگی شدید غیرقابل کنترل به تشخیص متخصص، و
وجود مری بارت در اندوسکوپی قبل عمل
معیارهای ورود:
رضایت به شرکت در مطالعه،
BMI زیر ۵۰ و بالای ۴۰،
سن ۱۸ تا ۶۵،
عمل اولیه،
جراحی OAGB،
طول بازو ۱۵۰،
طول آناستوموز ۴ سانت،
وجود ریفلاکس کلینیکی قبل عمل و در اندوسکوپی ریفلاکس گریدA, B, C،
و وجود هرنی هیاتال با هر اندازه. معیارهای عدم ورود عبارتند از ریسک بالای بیهوشی بعد از مشاوره قلب و ریه،
تشخیص جراح مبنی بر ریسک بالای جراحی،
عدم سلامت روان: مشکل جدی روانی شامل سایکوز و افسردگی شدید غیرقابل کنترل به تشخیص متخصص، و
وجود مری بارت در اندوسکوپی قبل عمل
معیارهای ورود عبارتند از: رضایت به شرکت در مطالعه، BMI زیر ۵۰ و بالای ۴۰، سن ۱۸ تا ۶۵، عمل اولیه، جراحی OAGB، طول بازو ۱۵۰، طول آناستوموز ۴ سانت، وجود ریفلاکس کلینیکی قبل عمل و در اندوسکوپی ریفلاکس گریدA, B, C، و وجود هرنی هیاتال با هر اندازه. معیارهای عدم ورود عبارتند از ریسک بالای بیهوشی بعد از مشاوره قلب و ریه، تشخیص جراح مبنی بر ریسک بالای جراحی، عدم سلامت روان: مشکل جدی روانی شامل سایکوز و افسردگی شدید غیرقابل کنترل به تشخیص متخصص، و وجود مری بارت در اندوسکوپی قبل عمل
1- Intervention group: One anastomosis gastric bypass without cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament.
2- Intervention group: One anastomosis gastric bypass with anterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Then an anterior cruroplasty is performed with Ethibond 2-0.
3- Intervention group: One anastomosis gastric bypass with posterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Then an posterior cruroplasty is performed with Ethibond 2-0.
1- Intervention group: One anastomosis gastric bypass without cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Treitz' ligament.
2- Intervention group: One anastomosis gastric bypass with anterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastrojejunostomy about 150cm distal to Treitz' ligament. Then an anterior cruroplasty is performed with Ethibond 2-0.
3- Intervention group: One anastomosis gastric bypass with posterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastrojejunostomy about 150cm distal to Treitz' ligament. Then a posterior cruroplasty is performed with Ethibond 2-0.
1- Intervention group: One anastomosis gastric bypass without cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to TrietzTreitz' ligament. 2- Intervention group: One anastomosis gastric bypass with anterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomygastrojejunostomy about 150cm distal to TrietzTreitz' ligament. Then an anterior cruroplasty is performed with Ethibond 2-0. 3- Intervention group: One anastomosis gastric bypass with posterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomygastrojejunostomy about 150cm distal to TrietzTreitz' ligament. Then ana posterior cruroplasty is performed with Ethibond 2-0.
Status of Gastroesophageal Reflux Disease
Status of Gastroesophageal Reflux
Status of Gastroesophageal Reflux Disease
General information
120
90
12090
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Hello. Respectfully The applied changes are: sample size: 90 (in three groups of 30) - place of study: Rasool-e Akram Hospital
Hello. Respectfully The applied changes are: sample size: 90 (in three groups of 30) - place of study: Rasool-e Akram Hospital
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تغییرات اعمال شده عبارتند از: حجم نمونه: 90 (در سه گروه 30 تایی)
محل انجام مطالعه: فقط بیمارستان رسول اکرم
تغییرات اعمال شده عبارتند از: حجم نمونه: 90 (در سه گروه 30 تایی) محل انجام مطالعه: فقط بیمارستان رسول اکرم
بررسی کارآیی ترمیم فتق دیافراگم(کروروپلاستی قدامی و خلفی) در بهبود ریفلاکس معده به مری پس از عمل بایپس تک آناستوموزی (OAGB)
بررسی کارآیی ترمیم فتق دیافراگم (کروروپلاستی قدامی و خلفی) در بهبود ریفلاکس معده به مری پس از عمل بایپس تک آناستوموزی (OAGB)
بررسی کارآیی ترمیم فتق دیافراگم(کروروپلاستیدیافراگم (کروروپلاستی قدامی و خلفی) در بهبود ریفلاکس معده به مری پس از عمل بایپس تک آناستوموزی (OAGB)
40
18
Primary bariatric surgery
OAGB Surgical Procedure
BP Limb of 150 cm
Anastomosis diameter 4 cm
Symptomatic clinical GERD before OAGB
GERD grade A, B, C in pre-op endoscopy
Any size of hiatal hernia
40
18
Primary surgery
OAGB Surgery
Biliopancreatic limb length of 150 cm
Anastomosis length of 4 cm
Symptomatic clinical reflux before surgery
Reflux grade A, B, C in endoscopy
Having hiatal hernia in any size
40
In this study, we will use Block Randomization method with six block sizes. Excel software and rand() function will be used to prepare random order inside each block. We will have 3 groups of 40 people. When the intervention of each participant is determined, then a unique four-digit code will be assigned to the person (concealment). This number is the randomization code of the participant and the person will be identified with this number until the end of the study. A chain of 120 random allocations for use in the first phase of the study will be kept by the main investigator.
In this study, we will use Block Randomization method with six block sizes. Excel software and rand() function will be used to prepare random order inside each block. We will have 3 groups of 30 people. When the intervention of each participant is determined, then a unique four-digit code will be assigned to the person (concealment). This number is the randomization code of the participant and the person will be identified with this number until the end of the study. A chain of 90 random allocations for use in the first phase of the study will be kept by the main investigator.
In this study, we will use Block Randomization method with six block sizes. Excel software and rand() function will be used to prepare random order inside each block. We will have 3 groups of 4030 people. When the intervention of each participant is determined, then a unique four-digit code will be assigned to the person (concealment). This number is the randomization code of the participant and the person will be identified with this number until the end of the study. A chain of 12090 random allocations for use in the first phase of the study will be kept by the main investigator.
از Block Randomization و سایز بلوک های 6 تایی استفاده می شود. از نرم افزار اکسل و فانکشن rand() برای تهیه ترتیب های تصادفی در داخل هر بلوک بهره گرفته می شود. 3 گروه 40 تایی خواهیم داشت. پس از تعیین نوع مداخله در هر شرکت کننده، یک کد غیر تکراری چهار رقمی به فرد اختصاص داده می شود (پنهان سازی). این شماره کد تصادفی سازی فرد شرکت کننده محسوب می شود و تا پایان مطالعه فرد با این شماره شناسایی خواهد شد. زنجیره 120 تایی اختصاص تصادفی برای استفاده نزد محقق اصلی مطالعه نگهداری خواهد شد.
از Block Randomization و سایز بلوک های 6 تایی استفاده می شود. از نرم افزار اکسل و فانکشن rand() برای تهیه ترتیب های تصادفی در داخل هر بلوک بهره گرفته می شود. 3 گروه 30 تایی خواهیم داشت. پس از تعیین نوع مداخله در هر شرکت کننده، یک کد غیر تکراری چهار رقمی به فرد اختصاص داده می شود (پنهان سازی). این شماره کد تصادفی سازی فرد شرکت کننده محسوب می شود و تا پایان مطالعه فرد با این شماره شناسایی خواهد شد. زنجیره 90 تایی اختصاص تصادفی برای استفاده نزد محقق اصلی مطالعه نگهداری خواهد شد.
از Block Randomization و سایز بلوک های 6 تایی استفاده می شود. از نرم افزار اکسل و فانکشن rand() برای تهیه ترتیب های تصادفی در داخل هر بلوک بهره گرفته می شود. 3 گروه 4030 تایی خواهیم داشت. پس از تعیین نوع مداخله در هر شرکت کننده، یک کد غیر تکراری چهار رقمی به فرد اختصاص داده می شود (پنهان سازی). این شماره کد تصادفی سازی فرد شرکت کننده محسوب می شود و تا پایان مطالعه فرد با این شماره شناسایی خواهد شد. زنجیره 12090 تایی اختصاص تصادفی برای استفاده نزد محقق اصلی مطالعه نگهداری خواهد شد.
بیماران از روش جراحی خود مطلع نمی باشند ولی به ایشان در مورد این سه روش کاملا توضیح می دهیم و هدف انجام این مطالعه برای ایشان بیان خواهد شد.همچنین برای ایشان این مطلب که تا کنون تفاوت اثر این سه روش بر ریفلاکس پس از عمل مشخص نیست توضیح داده می شود وپس از اخذ رضایت آگاهانه وارد مطالعه می شوند.
بیماران از روش جراحی خود مطلع نمی باشند ولی به ایشان در مورد این سه روش کاملا
توضیح می دهیم و هدف انجام این مطالعه برای ایشان بیان خواهد شد.همچنین برای ایشان این مطلب که تا کنون تفاوت اثر این سه روش بر ریفلاکس پس از عمل مشخص نیست توضیح داده می شود وپس از اخذ رضایت آگاهانه وارد مطالعه می شوند.
بیماران از روش جراحی خود مطلع نمی باشند ولی به ایشان در مورد این سه روش کاملا توضیح می دهیم و هدف انجام این مطالعه برای ایشان بیان خواهد شد.همچنین برای ایشان این مطلب که تا کنون تفاوت اثر این سه روش بر ریفلاکس پس از عمل مشخص نیست توضیح داده می شود وپس از اخذ رضایت آگاهانه وارد مطالعه می شوند.
Recruitment centers
#1
Name of recruitment center - English: Rasoul Akram Hospital Obesity Clinic
Name of recruitment center - Persian: کلینیک چاقی بیمارستان رسول اکرم
Full name of responsible person - English: Mohammad Kermansaravi
Full name of responsible person - Persian: محمد کرمان ساروی
Street address - English: Sattarkhan street, Niyayesh street, Rasool-e Akram hospital
Street address - Persian: بیمارتسان رسول اکرم، خیابان ستارخان، خیابان نیایش
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۵۶۱۳۱۳۱
Phone: +98 21 6655 5447
Fax:
Email: mkermansaravi@yahoo.com
Web page address:
Name of recruitment center - English: Rasoul Akram Hospital Obesity Clinic
Name of recruitment center - Persian: کلینیک چاقی بیمارستان رسول اکرم
Full name of responsible person - English: Mohammad Kermansaravi
Full name of responsible person - Persian: محمد کرمان ساروی
Street address - English: Sattarkhan street, Niyayesh street, Rasool-e Akram hospital
Street address - Persian: خیابان نیایش، خیابان ستارخان، بیمارستان رسول اکرم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 6655 5447
Fax:
Email: mkermansaravi@yahoo.com
Web page address:
Name of recruitment center - English: Rasoul Akram Hospital Obesity Clinic Name of recruitment center - Persian: کلینیک چاقی بیمارستان رسول اکرم Full name of responsible person - English: Mohammad Kermansaravi Full name of responsible person - Persian: محمد کرمان ساروی Street address - English: Sattarkhan street, Niyayesh street, Rasool-e Akram hospital Street address - Persian: بیمارتسان رسول اکرمخیابان نیایش، خیابان ستارخان، خیابان نیایشبیمارستان رسول اکرم City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۵۶۱۳۱۳۱1449614535 Phone: +98 21 6655 5447 Fax: Email: mkermansaravi@yahoo.com Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Kermansaravi
Full name of responsible person - Persian: محمد کرمان ساروی
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: sub_specialist
Area of specialty/work: 36
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 17, Morvarid 3, Sadaf Ave, Dadman Blvd, Qods Town
Street address - Persian: شهرک قدس ،بلوار دادمان ،کوی صدف، کوچه مروارید سوم ،پلاک 17 واحد 7
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 8809 5451
Mobile: +98 912 887 4084
Fax:
Email: kermansaravi.m@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Kermansaravi
Full name of responsible person - Persian: محمد کرمان ساروی
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: sub_specialist
Area of specialty/work: 36
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 17, 3th Morvarid, Sadaf Ave, Dadman Blvd, Qods Town
Street address - Persian: شهرک قدس ،بلوار دادمان ،کوی صدف، کوچه مروارید سوم ،پلاک 17، واحد 7
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 8809 5451
Mobile: +98 912 887 4084
Fax:
Email: kermansaravi.m@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mohammad Kermansaravi Full name of responsible person - Persian: محمد کرمان ساروی Position - English: Assistant professor Position - Persian: استادیار Latest degree: sub_specialist Area of specialty/work: 36 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No 17, 3th Morvarid 3, Sadaf Ave, Dadman Blvd, Qods Town Street address - Persian: شهرک قدس ،بلوار دادمان ،کوی صدف، کوچه مروارید سوم ،پلاک 17، واحد 7 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 8809 5451 Mobile: +98 912 887 4084 Fax: Email: kermansaravi.m@iums.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Kermansaravi
Full name of responsible person - Persian: محمد کرمان ساروی
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: sub_specialist
Area of specialty/work: 36
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 17, Morvarid 3, Sadaf Ave, Dadman Blvd, Qods Town
Street address - Persian: شهرک قدس ،بلوار دادمان ،کوی صدف، کوچه مروارید سوم ،پلاک 17 واحد 7
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8809 5451
Mobile: +98 912 887 4084
Fax:
Email: kermansaravi.m@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Kermansaravi
Full name of responsible person - Persian: محمد کرمان ساروی
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: sub_specialist
Area of specialty/work: 36
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 17, 3th Morvarid, Sadaf Ave, Dadman Blvd, Qods Town
Street address - Persian: شهرک قدس، بلوار دادمان، کوی صدف، کوچه مروارید سوم، پلاک 17، واحد 7
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8809 5451
Mobile: +98 912 887 4084
Fax:
Email: kermansaravi.m@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mohammad Kermansaravi Full name of responsible person - Persian: محمد کرمان ساروی Position - English: Assistant professor Position - Persian: استادیار Latest degree: sub_specialist Area of specialty/work: 36 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No 17, 3th Morvarid 3, Sadaf Ave, Dadman Blvd, Qods Town Street address - Persian: شهرک قدس،بلوار دادمان،کوی صدف، کوچه مروارید سوم،پلاک 17، واحد 7 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 8809 5451 Mobile: +98 912 887 4084 Fax: Email: kermansaravi.m@iums.ac.ir Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Kermansaravi
Full name of responsible person - Persian: محمد کرمان ساروی
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: sub_specialist
Area of specialty/work: 36
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 17, Morvarid 3, Sadaf Ave, Dadman Blvd, Qods Town
Street address - Persian: شهرک قدس ،بلوار دادمان ،کوی صدف، کوچه مروارید سوم ،پلاک 17 واحد 7
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8809 5451
Mobile: +98 912 887 4084
Fax:
Email: kermansaravi.m@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Kermansaravi
Full name of responsible person - Persian: محمد کرمان ساروی
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: sub_specialist
Area of specialty/work: 36
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 17, 3th Morvarid, Sadaf Ave, Dadman Blvd, Qods Town
Street address - Persian: شهرک قدس، بلوار دادمان، کوی صدف، کوچه مروارید سوم، پلاک 17، واحد 7
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8809 5451
Mobile: +98 912 887 4084
Fax:
Email: kermansaravi.m@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mohammad Kermansaravi Full name of responsible person - Persian: محمد کرمان ساروی Position - English: Assistant professor Position - Persian: استادیار Latest degree: sub_specialist Area of specialty/work: 36 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No 17, 3th Morvarid 3, Sadaf Ave, Dadman Blvd, Qods Town Street address - Persian: شهرک قدس،بلوار دادمان،کوی صدف، کوچه مروارید سوم،پلاک 17، واحد 7 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 8809 5451 Mobile: +98 912 887 4084 Fax: Email: kermansaravi.m@iums.ac.ir Web page address:
Protocol summary
Study aim
Evaluation the efficacy of anterior cruroplasty vs posterior .cruroplasty in improvement of Gastroesophageal reflux disease (GERD)after One-Anastomosis Gastric Bypass (OAGB)
Design
Clinical trial, with parallel groups, single-blind, randomized, on 90 patients
Settings and conduct
This trial will be conducted on 90 patients in Rasool-e Akram hospital. Patients will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 40<BMI<50, 18<age<65, Primary bariatric surgery
OAGB Surgical Procedure, BP Limb of 150 cm, Anastomosis diameter 4 cm
Symptomatic clinical GERD before OAGB, GERD grade A, B, C in pre-op endoscopy, Any size of hiatal hernia. Exclusion criteria were: High risk of anesthesia after heart and lung counseling, Diagnosing the surgeon based on the high risk of surgery, Lack of mental health: Serious psychological problem including psychosis and severe, uncontrollable depression at the discretion of the specialist, and Barrett's esophagus in pre-op endoscopy.
Intervention groups
1- Intervention group: One anastomosis gastric bypass without cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Treitz' ligament.
2- Intervention group: One anastomosis gastric bypass with anterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastrojejunostomy about 150cm distal to Treitz' ligament. Then an anterior cruroplasty is performed with Ethibond 2-0.
3- Intervention group: One anastomosis gastric bypass with posterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastrojejunostomy about 150cm distal to Treitz' ligament. Then a posterior cruroplasty is performed with Ethibond 2-0.
Main outcome variables
Status of Gastroesophageal Reflux
General information
Reason for update
Hello. Respectfully The applied changes are: sample size: 90 (in three groups of 30) - place of study: Rasool-e Akram Hospital
Acronym
IRCT registration information
IRCT registration number:IRCT20190128042520N4
Registration date:2022-11-23, 1401/09/02
Registration timing:prospective
Last update:2024-01-06, 1402/10/16
Update count:1
Registration date
2022-11-23, 1401/09/02
Registrant information
Name
Mohammad Kermansaravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8809 5451
Email address
kermansaravi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of anterior cruroplasty versus posterior cruroplasty in improvement of Gastroesophageal reflux disease (GERD)after One Anastomosis Gastric Bypass (OAGB)
Public title
Evaluation the efficacy of diaphragmatic hernia repair in improvement of Gastroesophageal reflux disease (GERD)after One Anastomosis Gastric Bypass (OAGB)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
40<BMI<50
18<age<65
Primary surgery
OAGB Surgery
Biliopancreatic limb length of 150 cm
Anastomosis length of 4 cm
Symptomatic clinical reflux before surgery
Reflux grade A, B, C in endoscopy
Having hiatal hernia in any size
Exclusion criteria:
High risk of anesthesia after heart and lung counseling
Diagnosing the surgeon based on the high risk of surgery
Lack of mental health: Serious psychological problem including psychosis and severe uncontrollable depression at the discretion of the specialist
Barrett's esophagus in pre-op endoscopy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use Block Randomization method with six block sizes. Excel software and rand() function will be used to prepare random order inside each block. We will have 3 groups of 30 people. When the intervention of each participant is determined, then a unique four-digit code will be assigned to the person (concealment). This number is the randomization code of the participant and the person will be identified with this number until the end of the study. A chain of 90 random allocations for use in the first phase of the study will be kept by the main investigator.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients are not aware about the type of surgery, but all types will describe before performing surgery and the aim of study completely clarify for them. This issue that the efficacy of these three methods on postoperative reflux is unknown, completely describe for the patients and they include in study after obtaining the informed consent.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-11-16, 1401/08/25
Ethics committee reference number
IR.IUMS.REC.1401.646
Health conditions studied
1
Description of health condition studied
Gastro-esophageal reflux disease
ICD-10 code
K21
ICD-10 code description
Gastro-esophageal reflux disease
Primary outcomes
1
Description
Gastroesophageal Reflux Disease
Timepoint
Before surgery and 7 months after surgery
Method of measurement
Upper GI Endoscopy (esophagogastroduodenoscopy)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: One anastomosis gastric bypass without cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament.
Category
Treatment - Surgery
2
Description
Intervention group 2: One anastomosis gastric bypass with anterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Then an anterior cruroplasty is performed with Ethibond 2-0.
Category
Treatment - Surgery
3
Description
Intervention group 3: One anastomosis gastric bypass with posterior cruroplasty: The pouch is created as a narrow and long pouch over a 36Fr bougie distal to Crow's foot with a 40mm gastr-jejunostomy about 150cm distal to Trietz' ligament. Then an posterior cruroplasty is performed with Ethibond 2-0.