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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RYGB procedure arm 1 | Active Comparator | After failed sleeve, the patients will get a revisional procedure. The RYGB |
|
| OAGB procedure arm 2 | Active Comparator | After failed sleeve, the patients will get a revisional procedure. The OAGB |
|
| SADI-S procedure arm 3 | Active Comparator | After failed sleeve, the patients will get a revisional procedure. The SADI-S |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| revision surgery | Procedure | revision procedure after failed sleeve gastrectomy |
|
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bart Torensma, PHD | Contact | +31641389070 | bart@torensmaresearch.nl | |
| Mohamed Ashour, MD | Contact | +201002600970 | mohamed.ashour@alexu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Ashour, MD | University of Alexandria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madina Women's Hospital | Recruiting | Alexandria | Alexandria Governorate | 21531 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30903425 | Result | 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. | |
| 32636173 | Result | 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. |
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FAIR data of this study can be requested. All will be saved in the Castor Electronic data capture system.
After 2 and 5 years and after full analysis and publication the data will be available and stored for minimal 10 years.
Email the Principal investigator. Whereby access to an annonymous database site will be created.
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012086 | Reoperation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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A single-blind randomization procedure, in which patients and outpatient clinic nurses will be blinded to the study period p
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| 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 |
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 |
| 29625744 | Result | 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. |
| 32738545 | Result | 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. |
| 30542828 | Result | 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. |
| 33432483 | Result | 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. |
| Result | Sami S, Ragunath K. The Los Angeles Classification of Gastroesophageal Reflux Disease. Video Journal and Encyclopedia of GI Endoscopy. 2013;1:103-4. |