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

Weight Loss Clinical Trial

— RCTresleeve  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05608772
• Other study ID #: RCT-revision-3arms
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2029

Study information

• Verified date: November 2022
• Source: General Committee of Teaching Hospitals and Institutes, Egypt
• Contact: Bart Torensma, PHD
• Phone: +31641389070
• Email: bart[@]torensmaresearch.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 234
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• revision surgery
revision procedure after failed sleeve gastrectomy

Locations

Country	Name	City	State
Egypt	Madina Women's Hospital	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
General Committee of Teaching Hospitals and Institutes, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View Citation

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: 10.10 — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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 sys — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The number of participants who will have late complications related to surgery	the incidence of re-operations or complications will be collected	60 months
Other	The number of participants whereby revision surgery necessary after the RCT	the incidence of re-operations or other procedure will be collected	60 months
Other	The percentage Excess body weight loss (%EWL)	the amount of weight loss after revision surgery	60 months
Other	Incidence of Reflux	GERD classification	60 months
Other	Nutritional levels of albuminemia	the albuminemia level will be tested after surgery (g/dl)	60 months
Other	Nutritional levels of proteinemia	the proteinemia level will be tested after surgery (mg/dl)	60 months
Other	Nutritional levels of anemia	the anemia level will be tested after surgery (Mcl)	60 months
Other	Nutritional levels of calcemic	the calcemic level will be tested after surgery (mg/dl)	60 months
Other	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
Other	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
Other	VAS/NRS (incidence of pain)	pain scoring from 0-10 (0 is no pain 10 is most worst pain)	60 months
Other	Metabolic biomarkers Glucagon-like peptide-1 (GLP1)	the GLP1 level will be tested after surgery (mg/ml)	60 months
Other	Metabolic biomarkers Leptin	the Leptin level will be tested after surgery (mg/ml)	60 months
Other	Metabolic biomarkers Peptide YY ( PYY)	the PYY level will be tested after surgery (pg/ml)	60 months
Other	Metabolic biomarkers Ghrelin	the Ghrelin level will be tested after surgery (mg/ml)	60 months
Other	Metabolic biomarkers Insulin	the Insulin level will be tested after surgery (million units/ml)	60 months
Primary	The number of participants who will have early complications related to surgery	the incidence of re-operation, bleeding or leakages	6 weeks
Primary	The percentage Excess body weight loss (%EWL)	the amount of weight loss after revision surgery	3,6,12,24 months
Primary	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	Nutritional levels of albuminemia	the albuminemia level will be tested after surgery (g/dl)	3,6,12,24 months
Secondary	Nutritional levels of proteinemia	the proteinemia level will be tested after surgery (mg/dl)	3,6,12,24 months
Secondary	Nutritional levels of anemia	the anemia level will be tested after surgery (Mcl)	3,6,12,24 months
Secondary	Nutritional levels of calcemic	the calcemic level will be tested after surgery (mg/dl)	3,6,12,24 months
Secondary	Incidence of Reflux	GERD assessment	3,6,12,24 months
Secondary	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
Secondary	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
Secondary	VAS/NRS (incidence of pain)	pain scoring from 0-10 (0 is no pain 10 is most worst pain)	3,6,12,24 months
Secondary	Metabolic biomarkers Glucagon-like peptide-1 (GLP1)	the GLP1 level will be tested after surgery (mg/ml)	3,6,12,24 months
Secondary	Metabolic biomarkers Leptin	the Leptin level will be tested after surgery (mg/ml)	3,6,12,24 months
Secondary	Metabolic biomarkers Peptide YY ( PYY)	the PYY level will be tested after surgery (pg/ml)	3,6,12,24 months
Secondary	Metabolic biomarkers Ghrelin	the Ghrelin level will be tested after surgery (mg/ml)	3,6,12,24 months
Secondary	Metabolic biomarkers Insulin	the Insulin level will be tested after surgery (million units/ml)	3,6,12,24 months