Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05608772
Other study ID # RCT-revision-3arms
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Active, not recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Terminated NCT03316105 - Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers N/A
Completed NCT03700736 - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups N/A
Active, not recruiting NCT04353726 - Knowledge-based Dietary Weight Management. N/A
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03377244 - Healthy Body Healthy Souls in the Marshallese Population N/A
Completed NCT02877004 - LLLT for Reducing Waste Circumference and Weight N/A
Active, not recruiting NCT04327141 - Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women N/A
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Recruiting NCT05249465 - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention N/A
Recruiting NCT05942326 - Sleep Goal-focused Online Access to Lifestyle Support N/A
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin
Not yet recruiting NCT03601273 - Bariatric Embolization Trial for the Obese Nonsurgical Phase 1
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT02945410 - Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity N/A
Completed NCT03139760 - POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT02948517 - Time Restricted Feeding for Weight Loss and Cardio-protection N/A
Recruiting NCT02559479 - A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes N/A