Weight LossRCTresleeveNCT05608772
Conversion to SADI-S, RYGB or OAGB After Failed Sleeve
A study testing revision surgery in people with Weight Loss and Bariatric Surgery Candidate, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Bariatric Surgery Candidate, Comorbidities and Coexisting Conditions
- What is being tested?
- revision surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2023to 15 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Didn't follow preoperative consultation
- Cannot give of sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Madina Women's Hospital
Alexandria, Alexandria Governorate, 21531
Mohamed Ashour, PhD, 00201002600970, dr.mhany@gmail.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Weight Loss, Bariatric Surgery Candidate, Comorbidities and Coexisting Conditions, Nutrient Deficiency
- Being tested
- revision surgery
- Keywords
- RYGB, OAGB, SADI-S, Sleeve gastrectomy
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
revision surgeryProcedure or surgery
revision procedure after failed sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| RYGB procedure arm 1 | Active comparator | After failed sleeve, the patients will get a revisional procedure. The RYGB Receives: Procedure: revision surgery |
| OAGB procedure arm 2 | Active comparator | After failed sleeve, the patients will get a revisional procedure. The OAGB Receives: Procedure: revision surgery |
| SADI-S procedure arm 3 | Active comparator | After failed sleeve, the patients will get a revisional procedure. The SADI-S Receives: Procedure: revision surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who will have early complications related to surgery
the incidence of re-operation, bleeding or leakages
Measured: 6 weeks
The percentage Excess body weight loss (%EWL)
the amount of weight loss after revision surgery
Measured: 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
Measured: 2,6 weeks and 3,6,12,24 months
Secondary outcomes (13)
Nutritional levels of albuminemia
the albuminemia level will be tested after surgery (g/dl)
Measured: 3,6,12,24 months
Nutritional levels of proteinemia
the proteinemia level will be tested after surgery (mg/dl)
Measured: 3,6,12,24 months
Nutritional levels of anemia
the anemia level will be tested after surgery (Mcl)
Measured: 3,6,12,24 months
Nutritional levels of calcemic
the calcemic level will be tested after surgery (mg/dl)
Measured: 3,6,12,24 months
Incidence of Reflux
GERD assessment
Measured: 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
Measured: 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).
Measured: 3,6,12,24 months
VAS/NRS (incidence of pain)
pain scoring from 0-10 (0 is no pain 10 is most worst pain)
Measured: 3,6,12,24 months
Metabolic biomarkers Glucagon-like peptide-1 (GLP1)
the GLP1 level will be tested after surgery (mg/ml)
Measured: 3,6,12,24 months
Metabolic biomarkers Leptin
the Leptin level will be tested after surgery (mg/ml)
Measured: 3,6,12,24 months
Metabolic biomarkers Peptide YY ( PYY)
the PYY level will be tested after surgery (pg/ml)
Measured: 3,6,12,24 months
Metabolic biomarkers Ghrelin
the Ghrelin level will be tested after surgery (mg/ml)
Measured: 3,6,12,24 months
Metabolic biomarkers Insulin
the Insulin level will be tested after surgery (million units/ml)
Measured: 3,6,12,24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start15 Mar 2023
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blind randomization procedure, in which patients and outpatient clinic nurses will be blinded to the study period p
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt
- Investigators
- Mohamed Ashour, MD, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608772
- Sponsor's protocol ID
- RCT-revision-3arms
- Acronym
- RCTresleeve
- Status last verified
- Sep 2025
- First submitted
- 25 Oct 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: FAIR data of this study can be requested. All will be saved in the Castor Electronic data capture system.
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.
PubMed 30903425Lazzati 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.
PubMed 32636173Clapp 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.
PubMed 29625744Parmar 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.
PubMed 32738545Chiappetta 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.
PubMed 30542828Angrisani 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.
PubMed 33432483Sami S, Ragunath K. The Los Angeles Classification of Gastroesophageal Reflux Disease. Video Journal and Encyclopedia of GI Endoscopy. 2013;1:103-4.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion of Failed Sleeve Gastrectomy Due to Weight Regain to SADI-S, RYGB or OAGB
- ClinicalTrials.gov ID
- NCT05608772
- Acronym / sponsor ID
- RCTresleeve / RCT-revision-3arms
- Conditions
- Weight Loss, Bariatric Surgery Candidate, Comorbidities and Coexisting Conditions, Nutrient Deficiency
- Keywords
- RYGB, OAGB, SADI-S, Sleeve gastrectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A single-blind randomization procedure, in which patients and outpatient clinic nurses will be blinded to the study period p
| Arm | Type | Receives |
|---|---|---|
| RYGB procedure arm 1 | Active comparator | Procedure: revision surgeryAfter failed sleeve, the patients will get a revisional procedure. The RYGB |
| OAGB procedure arm 2 | Active comparator | Procedure: revision surgeryAfter failed sleeve, the patients will get a revisional procedure. The OAGB |
| SADI-S procedure arm 3 | Active comparator | Procedure: revision surgeryAfter failed sleeve, the patients will get a revisional procedure. The SADI-S |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Undergone primary laparoscopic sleeve gastrectomy in the past
- Weight regain
- 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
Key exclusion criteria (2 listed)
- Didn't follow preoperative consultation
- Cannot give of sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| revision surgeryrevision procedure after failed sleeve gastrectomy | Procedure or surgery | OAGB procedure arm 2, RYGB procedure arm 1, SADI-S procedure arm 3 |
Primary outcome
The number of participants who will have early complications related to surgery
Time frame: 6 weeks
the incidence of re-operation, bleeding or leakages
The percentage Excess body weight loss (%EWL)
Time frame: 3,6,12,24 months
the amount of weight loss after revision surgery
somscore of food tolerance
Time frame: 2,6 weeks and 3,6,12,24 months
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
13 secondary outcomes
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
Metabolic biomarkers Insulin
Time frame: 3,6,12,24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Results publication: PubMed 30903425Guan 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.
- Results publication: PubMed 32636173Lazzati 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.
- Results publication: PubMed 29625744Clapp 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.
- Results publication: PubMed 32738545Parmar 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.
- Results publication: PubMed 30542828Chiappetta 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.
- Results publication: PubMed 33432483Angrisani 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.
- Results publicationSami S, Ragunath K. The Los Angeles Classification of Gastroesophageal Reflux Disease. Video Journal and Encyclopedia of GI Endoscopy. 2013;1:103-4.
- Individual participant dataSharing planned: Yes. FAIR data of this study can be requested. All will be saved in the Castor Electronic data capture system.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Ashour, MD principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing revision surgery in people with Weight Loss and Bariatric Surgery Candidate, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bart Torensma, PHD (+31641389070, bart@torensmaresearch.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants who will have early complications related to surgery (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05608772, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.