Clinical trial NCT05608772: Conversion to SADI-S, RYGB or OAGB After Failed Sleeve
Official title: Conversion of Failed Sleeve Gastrectomy Due to Weight Regain to SADI-S, RYGB or OAGB
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Weight Loss
Bariatric Surgery Candidate
Comorbidities and Coexisting Conditions
Nutrient Deficiency
Keywords: RYGB
OAGB
SADI-S
Sleeve gastrectomy
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
First posted: 2022-11-08
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blind randomization procedure, in which patients and outpatient clinic nurses will be blinded to the study period p
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: The number of participants who will have early complications related to surgery
timeFrame: 6 weeks
measure: The percentage Excess body weight loss (%EWL)
timeFrame: 3,6,12,24 months
measure: somscore of food tolerance
timeFrame: 2,6 weeks and 3,6,12,24 months
Secondary outcomes:
measure: Nutritional levels of albuminemia
timeFrame: 3,6,12,24 months
measure: Nutritional levels of proteinemia
timeFrame: 3,6,12,24 months
measure: Nutritional levels of anemia
timeFrame: 3,6,12,24 months
measure: Nutritional levels of calcemic
timeFrame: 3,6,12,24 months
measure: Incidence of Reflux
timeFrame: 3,6,12,24 months
measure: The number of participants who will have late complications related to surgery
timeFrame: 3,6,12,24 months
measure: Short Form 36 Quality of life
timeFrame: 3,6,12,24 months
measure: VAS/NRS (incidence of pain)
timeFrame: 3,6,12,24 months
measure: Metabolic biomarkers Glucagon-like peptide-1 (GLP1)
timeFrame: 3,6,12,24 months
measure: Metabolic biomarkers Leptin
timeFrame: 3,6,12,24 months
measure: Metabolic biomarkers Peptide YY ( PYY)
timeFrame: 3,6,12,24 months
measure: Metabolic biomarkers Ghrelin
timeFrame: 3,6,12,24 months
measure: Metabolic biomarkers Insulin
timeFrame: 3,6,12,24 months
Other outcomes:
measure: The number of participants who will have late complications related to surgery
timeFrame: 60 months
measure: The number of participants whereby revision surgery necessary after the RCT
timeFrame: 60 months
measure: The percentage Excess body weight loss (%EWL)
timeFrame: 60 months
measure: Incidence of Reflux
timeFrame: 60 months
measure: Nutritional levels of albuminemia
timeFrame: 60 months
measure: Nutritional levels of proteinemia
timeFrame: 60 months
measure: Nutritional levels of anemia
timeFrame: 60 months
measure: Nutritional levels of calcemic
timeFrame: 60 months
measure: Somscore of food tolerance
timeFrame: 60 months
measure: Short Form 36 Quality of life
timeFrame: 60 months
measure: VAS/NRS (incidence of pain)
timeFrame: 60 months
measure: Metabolic biomarkers Glucagon-like peptide-1 (GLP1)
timeFrame: 60 months
measure: Metabolic biomarkers Leptin
timeFrame: 60 months
measure: Metabolic biomarkers Peptide YY ( PYY)
timeFrame: 60 months
measure: Metabolic biomarkers Ghrelin
timeFrame: 60 months
measure: Metabolic biomarkers Insulin
timeFrame: 60 months
Locations:
city: Alexandria
country: Egypt
facility: Madina Women's Hospital
Study officials:
affiliation: University of Alexandria
name: Mohamed Ashour, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Sami S, Ragunath K. The Los Angeles Classification of Gastroesophageal Reflux Disease. Video Journal and Encyclopedia of GI Endoscopy. 2013;1:103-4.