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

Not Applicable

Not yet recruiting

• Conditions: Weight Loss; Comorbidities and Coexisting Conditions; Nutrient Deficiency; Bariatric Surgery Candidate
• Interventions: Procedure: revision surgery

• Registration Number: NCT05608772
• Lead Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt

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.

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 Timeline

• Study First Submitted: 2022-10-25
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-02
• Last Update Submitted: 2022-11-02
• Study First Posted: 2022-11-08
• Last Update Posted: 2022-11-08
• Study Start: 2023-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 234

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RYGB procedure arm 1	revision surgery	After failed sleeve, the patients will get a revisional procedure. The RYGB
OAGB procedure arm 2	revision surgery	After failed sleeve, the patients will get a revisional procedure. The OAGB
SADI-S procedure arm 3	revision surgery	After failed sleeve, the patients will get a revisional procedure. The SADI-S

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Incidence of Reflux	3,6,12,24 months	GERD assessment
Metabolic biomarkers Peptide YY ( PYY)	3,6,12,24 months	the PYY level will be tested after surgery (pg/ml)
Nutritional levels of proteinemia	3,6,12,24 months	the proteinemia level will be tested after surgery (mg/dl)
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 Ghrelin	3,6,12,24 months	the Ghrelin level will be tested after surgery (mg/ml)
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 Insulin	3,6,12,24 months	the Insulin level will be tested after surgery (million units/ml)
Nutritional levels of albuminemia	3,6,12,24 months	the albuminemia level will be tested after surgery (g/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)
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).

Trial Locations

Locations (1)

Madina Women's Hospital; 🇪🇬 Alexandria, Egypt