RCTresleeve: Conversion to SADI-S, RYGB or OAGB After Failed Sleeve
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- The number of participants who will have early complications related to surgery [6 weeks]
the incidence of re-operation, bleeding or leakages
- The percentage Excess body weight loss (%EWL) [3,6,12,24 months]
the amount of weight loss after revision surgery
- somscore of food tolerance [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
Secondary Outcome Measures
- Nutritional levels of albuminemia [3,6,12,24 months]
the albuminemia level will be tested after surgery (g/dl)
- Nutritional levels of proteinemia [3,6,12,24 months]
the proteinemia level will be tested after surgery (mg/dl)
- Nutritional levels of anemia [3,6,12,24 months]
the anemia level will be tested after surgery (Mcl)
- Nutritional levels of calcemic [3,6,12,24 months]
the calcemic level will be tested after surgery (mg/dl)
- Incidence of Reflux [3,6,12,24 months]
GERD assessment
- The number of participants who will have late complications related to surgery [3,6,12,24 months]
the incidence of re-operations will be collected
- Short Form 36 Quality of life [3,6,12,24 months]
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).
- VAS/NRS (incidence of pain) [3,6,12,24 months]
pain scoring from 0-10 (0 is no pain 10 is most worst pain)
- Metabolic biomarkers Glucagon-like peptide-1 (GLP1) [3,6,12,24 months]
the GLP1 level will be tested after surgery (mg/ml)
- Metabolic biomarkers Leptin [3,6,12,24 months]
the Leptin level will be tested after surgery (mg/ml)
- Metabolic biomarkers Peptide YY ( PYY) [3,6,12,24 months]
the PYY level will be tested after surgery (pg/ml)
- Metabolic biomarkers Ghrelin [3,6,12,24 months]
the Ghrelin level will be tested after surgery (mg/ml)
- Metabolic biomarkers Insulin [3,6,12,24 months]
the Insulin level will be tested after surgery (million units/ml)
Other Outcome Measures
- The number of participants who will have late complications related to surgery [60 months]
the incidence of re-operations or complications will be collected
- The number of participants whereby revision surgery necessary after the RCT [60 months]
the incidence of re-operations or other procedure will be collected
- The percentage Excess body weight loss (%EWL) [60 months]
the amount of weight loss after revision surgery
- Incidence of Reflux [60 months]
GERD classification
- Nutritional levels of albuminemia [60 months]
the albuminemia level will be tested after surgery (g/dl)
- Nutritional levels of proteinemia [60 months]
the proteinemia level will be tested after surgery (mg/dl)
- Nutritional levels of anemia [60 months]
the anemia level will be tested after surgery (Mcl)
- Nutritional levels of calcemic [60 months]
the calcemic level will be tested after surgery (mg/dl)
- Somscore of food tolerance [60 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
- Short Form 36 Quality of life [60 months]
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).
- VAS/NRS (incidence of pain) [60 months]
pain scoring from 0-10 (0 is no pain 10 is most worst pain)
- Metabolic biomarkers Glucagon-like peptide-1 (GLP1) [60 months]
the GLP1 level will be tested after surgery (mg/ml)
- Metabolic biomarkers Leptin [60 months]
the Leptin level will be tested after surgery (mg/ml)
- Metabolic biomarkers Peptide YY ( PYY) [60 months]
the PYY level will be tested after surgery (pg/ml)
- Metabolic biomarkers Ghrelin [60 months]
the Ghrelin level will be tested after surgery (mg/ml)
- Metabolic biomarkers Insulin [60 months]
the Insulin level will be tested after surgery (million units/ml)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Madina Women's Hospital | Alexandria | Egypt | 21531 |
Sponsors and Collaborators
- General Committee of Teaching Hospitals and Institutes, Egypt
Investigators
- Principal Investigator: Mohamed Ashour, MD, University of Alexandria
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RCT-revision-3arms