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

General Committee of Teaching Hospitals and Institutes, Egypt

Status: Enrolling

Conditions: Weight Loss; Bariatric Surgery Candidate; Comorbidities and Coexisting Conditions; Nutrient Deficiency

Treatments: Procedure: revision surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05608772

RCT-revision-3arms

Details and patient eligibility

About

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.

Full 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).

Enrollment: 234 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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234 participants in 3 patient groups

RYGB procedure arm 1

Active Comparator group

Description:

After failed sleeve, the patients will get a revisional procedure. The RYGB

Treatment:

Procedure: revision surgery

OAGB procedure arm 2

Active Comparator group

Description:

After failed sleeve, the patients will get a revisional procedure. The OAGB

Treatment:

Procedure: revision surgery

SADI-S procedure arm 3

Active Comparator group

Description:

After failed sleeve, the patients will get a revisional procedure. The SADI-S

Treatment:

Procedure: revision surgery