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.

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

Weight Loss

Bariatric Surgery Candidate

Comorbidities and Coexisting Conditions

Nutrient Deficiency

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).

revision surgery

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

the incidence of re-operation, bleeding or leakages

the amount of weight loss after revision surgery

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

ass professor

the albuminemia level will be tested after surgery (g/dl)

the proteinemia level will be tested after surgery (mg/dl)

the anemia level will be tested after surgery (Mcl)

the calcemic level will be tested after surgery (mg/dl)

the incidence of re-operations will be collected

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).

pain scoring from 0-10 (0 is no pain 10 is most worst pain)

the GLP1 level will be tested after surgery (mg/ml)

the Leptin level will be tested after surgery (mg/ml)

the PYY level will be tested after surgery (pg/ml)

the Ghrelin level will be tested after surgery (mg/ml)

the Insulin level will be tested after surgery (million units/ml)

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

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

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

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status