Menu
Recruiting NCT05608772

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

No phase Interventional Weight Loss Bariatric Surgery Candidate Comorbidities and Coexisting Conditions Nutrient Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: revision surgery.
Who it may be relevant to
Registry conditions: Weight Loss, Bariatric Surgery Candidate, Comorbidities and Coexisting Conditions, Nutrient Deficiency. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Procedure revision surgery
    revision procedure after failed sleeve gastrectomy

Primary outcome measures

  • The number of participants who will have early complications related to surgery [Time frame: 6 weeks]
  • The percentage Excess body weight loss (%EWL) [Time frame: 3,6,12,24 months]
  • somscore of food tolerance [Time frame: 2,6 weeks and 3,6,12,24 months]
Secondary outcome measures (12)
  • Nutritional levels of albuminemia [Time frame: 3,6,12,24 months]
  • Nutritional levels of proteinemia [Time frame: 3,6,12,24 months]
  • Nutritional levels of anemia [Time frame: 3,6,12,24 months]
  • Nutritional levels of calcemic [Time frame: 3,6,12,24 months]
  • Incidence of Reflux [Time frame: 3,6,12,24 months]
  • The number of participants who will have late complications related to surgery [Time frame: 3,6,12,24 months]
  • Short Form 36 Quality of life [Time frame: 3,6,12,24 months]
  • VAS/NRS (incidence of pain) [Time frame: 3,6,12,24 months]
  • Metabolic biomarkers Glucagon-like peptide-1 (GLP1) [Time frame: 3,6,12,24 months]
  • Metabolic biomarkers Leptin [Time frame: 3,6,12,24 months]
  • Metabolic biomarkers Peptide YY ( PYY) [Time frame: 3,6,12,24 months]
  • Metabolic biomarkers Ghrelin [Time frame: 3,6,12,24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Madina Women's Hospital — Alexandria

Publications

  • 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.

Identifiers

NCT: NCT05608772 · RCT-revision-3arms

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗