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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Weight Loss; Bariatric Surgery Candidate; Nutrient Deficiency; Comorbidities and Coexisting Conditions
• Intervention / Treatment: Procedure: revision surgery

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).

• Study Type: Interventional
• Enrollment (Estimated): 234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bart Torensma, PHD; Phone Number: +31641389070; Email: bart@torensmaresearch.nl
• Study Contact Backup: Name: Mohamed Ashour, MD; Phone Number: +201002600970; Email: mohamed.ashour@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria Governorate
    • Alexandria, Alexandria Governorate, Egypt, 21531
      • Recruiting
      • Madina Women's Hospital
      • Contact: Mohamed Ashour, PhD; Phone Number: 00201002600970; Email: dr.mhany@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RYGB procedure arm 1; After failed sleeve, the patients will get a revisional procedure. The RYGB	Procedure: revision surgery; revision procedure after failed sleeve gastrectomy
Active Comparator: OAGB procedure arm 2; After failed sleeve, the patients will get a revisional procedure. The OAGB	Procedure: revision surgery; revision procedure after failed sleeve gastrectomy
Active Comparator: SADI-S procedure arm 3; After failed sleeve, the patients will get a revisional procedure. The SADI-S	Procedure: revision surgery; revision procedure after failed sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants who will have early complications related to surgery	the incidence of re-operation, bleeding or leakages	6 weeks
The percentage Excess body weight loss (%EWL)	the amount of weight loss after revision surgery	3,6,12,24 months
somscore of food tolerance	validated food tolerance questions: Food tolerance (FT) was evaluated using a one-page questionnaire divided into 4 sections, 3 of which were used to calculate the score: overall patient satisfaction with eating (score: 1-5); tolerability to certain food types (score: 0-16); and frequency of vomiting/regurgitation (score: 0-6), with a total score between 1 and 27; higher scores indicate better food tolerance	2,6 weeks and 3,6,12,24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional levels of albuminemia	the albuminemia level will be tested after surgery (g/dl)	3,6,12,24 months
Nutritional levels of proteinemia	the proteinemia level will be tested after surgery (mg/dl)	3,6,12,24 months
Nutritional levels of anemia	the anemia level will be tested after surgery (Mcl)	3,6,12,24 months
Nutritional levels of calcemic	the calcemic level will be tested after surgery (mg/dl)	3,6,12,24 months
Incidence of Reflux	GERD assessment	3,6,12,24 months
The number of participants who will have late complications related to surgery	the incidence of re-operations will be collected	3,6,12,24 months
Short Form 36 Quality of life	Quality of life assessment will be tested 8 chapters with in total 36 questions and a somscore from 0-100 will be calculated (the higher the somscore the better the quality of life is).	3,6,12,24 months
VAS/NRS (incidence of pain)	pain scoring from 0-10 (0 is no pain 10 is most worst pain)	3,6,12,24 months
Metabolic biomarkers Glucagon-like peptide-1 (GLP1)	the GLP1 level will be tested after surgery (mg/ml)	3,6,12,24 months
Metabolic biomarkers Leptin	the Leptin level will be tested after surgery (mg/ml)	3,6,12,24 months
Metabolic biomarkers Peptide YY ( PYY)	the PYY level will be tested after surgery (pg/ml)	3,6,12,24 months
Metabolic biomarkers Ghrelin	the Ghrelin level will be tested after surgery (mg/ml)	3,6,12,24 months
Metabolic biomarkers Insulin	the Insulin level will be tested after surgery (million units/ml)	3,6,12,24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants who will have late complications related to surgery	the incidence of re-operations or complications will be collected	60 months
The number of participants whereby revision surgery necessary after the RCT	the incidence of re-operations or other procedure will be collected	60 months
The percentage Excess body weight loss (%EWL)	the amount of weight loss after revision surgery	60 months
Incidence of Reflux	GERD classification	60 months
Nutritional levels of albuminemia	the albuminemia level will be tested after surgery (g/dl)	60 months
Nutritional levels of proteinemia	the proteinemia level will be tested after surgery (mg/dl)	60 months
Nutritional levels of anemia	the anemia level will be tested after surgery (Mcl)	60 months
Nutritional levels of calcemic	the calcemic level will be tested after surgery (mg/dl)	60 months
Somscore of food tolerance	validated food tolerance questions: Food tolerance (FT) was evaluated using a one-page questionnaire divided into 4 sections, 3 of which were used to calculate the score: overall patient satisfaction with eating (score: 1-5); tolerability to certain food types (score: 0-16); and frequency of vomiting/regurgitation (score: 0-6), with a total score between 1 and 27; higher scores indicate better food tolerance	60 months
Short Form 36 Quality of life	Quality of life assessment will be tested 8 chapters with in total 36 questions and a somscore from 0-100 will be calculated (the higher the somscore the better the quality of life is).	60 months
VAS/NRS (incidence of pain)	pain scoring from 0-10 (0 is no pain 10 is most worst pain)	60 months
Metabolic biomarkers Glucagon-like peptide-1 (GLP1)	the GLP1 level will be tested after surgery (mg/ml)	60 months
Metabolic biomarkers Leptin	the Leptin level will be tested after surgery (mg/ml)	60 months
Metabolic biomarkers Peptide YY ( PYY)	the PYY level will be tested after surgery (pg/ml)	60 months
Metabolic biomarkers Ghrelin	the Ghrelin level will be tested after surgery (mg/ml)	60 months
Metabolic biomarkers Insulin	the Insulin level will be tested after surgery (million units/ml)	60 months

Collaborators and Investigators

• Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
• Investigators: Principal Investigator: Mohamed Ashour, MD, University of Alexandria

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): April 15, 2028

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Sleeve gastrectomy; RYGB; SADI-S; OAGB
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Weight Loss; Surgical Procedures, Operative; Reoperation
• Other Study ID Numbers: RCT-revision-3arms

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: FAIR data of this study can be requested. All will be saved in the Castor Electronic data capture system.
• IPD Sharing Time Frame: After 2 and 5 years and after full analysis and publication the data will be available and stored for minimal 10 years.
• IPD Sharing Access Criteria: Email the Principal investigator. Whereby access to an annonymous database site will be created.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No