Conversion to SADI-S, RYGB or OAGB After Failed Sleeve

Официальное название

Conversion of Failed Sleeve Gastrectomy Due to Weight Regain to SADI-S, RYGB or OAGB

Обзор

Assess what revisional surgery is superior and provides the best weight loss after primary LSG. What is the occurrence of complications and the nutritional laboratory status? And if the resolution and /or improvement of associated medical problems after the weight loss will occur.

Подробное описание

Laparoscopic sleeve gastrectomy (LSG) gained popularity and has become one of the most performed weight loss procedures worldwide. In the long-term follow-up, the literature states that the incidence of gastroesophageal reflux disease (GERD) accounts for 16%, and weight regains accounting for 70% after LSG. These are the two most common complications which can necessitate further surgical intervention.

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).

Вмешательства

• Процедура revision surgery
  revision procedure after failed sleeve gastrectomy

Первичные конечные точки

• The number of participants who will have early complications related to surgery [Срок оценки: 6 weeks]
• The percentage Excess body weight loss (%EWL) [Срок оценки: 3,6,12,24 months]
• somscore of food tolerance [Срок оценки: 2,6 weeks and 3,6,12,24 months]

Вторичные конечные точки (12)

• Nutritional levels of albuminemia [Срок оценки: 3,6,12,24 months]
• Nutritional levels of proteinemia [Срок оценки: 3,6,12,24 months]
• Nutritional levels of anemia [Срок оценки: 3,6,12,24 months]
• Nutritional levels of calcemic [Срок оценки: 3,6,12,24 months]
• Incidence of Reflux [Срок оценки: 3,6,12,24 months]
• The number of participants who will have late complications related to surgery [Срок оценки: 3,6,12,24 months]
• Short Form 36 Quality of life [Срок оценки: 3,6,12,24 months]
• VAS/NRS (incidence of pain) [Срок оценки: 3,6,12,24 months]
• Metabolic biomarkers Glucagon-like peptide-1 (GLP1) [Срок оценки: 3,6,12,24 months]
• Metabolic biomarkers Leptin [Срок оценки: 3,6,12,24 months]
• Metabolic biomarkers Peptide YY ( PYY) [Срок оценки: 3,6,12,24 months]
• Metabolic biomarkers Ghrelin [Срок оценки: 3,6,12,24 months]

Критерии участия

Критерии включения

• Undergone primary laparoscopic sleeve gastrectomy in the past
• 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

Критерии исключения

• Didn't follow preoperative consultation
• Cannot give of sign informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Madina Women's Hospital — Alexandria

Публикации

• 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. PMID 30903425
• 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. PMID 32636173
• 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. PMID 29625744
• 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. PMID 32738545
• 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. PMID 30542828
• 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. PMID 33432483
• Sami S, Ragunath K. The Los Angeles Classification of Gastroesophageal Reflux Disease. Video Journal and Encyclopedia of GI Endoscopy. 2013;1:103-4.

Идентификаторы

NCT: NCT05608772 · RCT-revision-3arms

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗