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

NCT05608772 | Recruiting DMC

• 1 other identifier: RCT-revision-3arms
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Bariatric Surgery Candidate; Comorbidities and Coexisting Conditions; Nutrient Deficiency

Keywords

RYGB; OAGB; SADI-S; Sleeve gastrectomy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Nutritional levels of albuminemia

  3,6,12,24 months

• Nutritional levels of proteinemia

  3,6,12,24 months

• Nutritional levels of anemia

  3,6,12,24 months

• Nutritional levels of calcemic

  3,6,12,24 months

• Incidence of Reflux

  3,6,12,24 months

Other Outcomes (16)

• The number of participants who will have late complications related to surgery

  60 months

• The number of participants whereby revision surgery necessary after the RCT

  60 months

• The percentage Excess body weight loss (%EWL)

  60 months

Study Arms (3)

RYGB procedure arm 1

ACTIVE COMPARATOR

After failed sleeve, the patients will get a revisional procedure. The RYGB

Procedure: revision surgery

OAGB procedure arm 2

ACTIVE COMPARATOR

After failed sleeve, the patients will get a revisional procedure. The OAGB

Procedure: revision surgery

SADI-S procedure arm 3

ACTIVE COMPARATOR

After failed sleeve, the patients will get a revisional procedure. The SADI-S

Procedure: revision surgery

Interventions

revision surgery PROCEDURE

revision procedure after failed sleeve gastrectomy

OAGB procedure arm 2; RYGB procedure arm 1; SADI-S procedure arm 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

Madina Women's Hospital

Alexandria, Alexandria Governorate, 21531, Egypt

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Weight Loss

Interventions

Reoperation

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Mohamed Ashour, MD

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bart Torensma, PHD

CONTACT

+31641389070; bart@torensmaresearch.nl

Mohamed Ashour, MD

CONTACT

+201002600970; mohamed.ashour@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ass professor

Model Details: A single-blind randomization procedure, in which patients and outpatient clinic nurses will be blinded to the study period p

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 8, 2022
• Study Start: March 15, 2023
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): April 15, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After 2 and 5 years and after full analysis and publication the data will be available and stored for minimal 10 years.
• Access Criteria: Email the Principal investigator. Whereby access to an annonymous database site will be created.

Locations

EG (1)