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Not yet recruiting NCT05948852

Two Hypoabsorption Techniques for the Treatment of Type III Obesity (OASIS)

No phase Interventional Obesity, Morbid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: metabolic surgery (SADIS and OAGB).
Who it may be relevant to
Registry conditions: Obesity, Morbid. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Randomized Prospective Study Comparing Two Hypoabsorption Techniques for the Treatment of Type III Obesity (Body Mass Index Between 45 - 49.9 Kg/m2): Single Anastomose Duodenal Switch (SADI-S) and Single Anastomose Gastric By-pass (OAGBP)

Overview

This study aims to compare the percentage of total weight lost in long-term follow-up after two surgical interventions (SADIS and OAGB) in patients with morbid obesity BMI between 45-49.9.

Interventions

  • Procedure metabolic surgery (SADIS and OAGB)
    TWO HYPOABSORPTION TECHNIQUES FOR THE TREATMENT OF TYPE III OBESITY (BODY MASS INDEX BETWEEN 45 - 49.9 KG/M2): SINGLE ANASTOMOSE DUODENAL SWITCH (SADI-S) AND SINGLE ANASTOMOSE GASTRIC BY-PASS (OAGBP).

Primary outcome measures

  • the percentage of total weight loss (%TWL) of the patients after surgery [Time frame: Baseline, 1 year, 3 year, 5 year after SADI-S and OAGBP surgery]
Secondary outcome measures (6)
  • % of patients with gastroesophageal reflux (acid and bile) after surgery [Time frame: 1 year, 3 year, 5 year after SADI-S and OAGBP surgery]
  • Number of deaths in the immediate postoperative period [Time frame: up to day 90 post-intervention]
  • Number of Participants with complications in the immediate postoperative period [Time frame: up to day 90 post-intervention]
  • Ratio of patients with more than 3 loose stools per day [Time frame: 1 year, 3 years, 5 years after the surgery]
  • questionnaire of quality of life [Time frame: 1 year, 3 years, 5 years after SADI-S and OAGBP surgery]
  • Number of patients with nutritional deficiencies [Time frame: 1 year, 3 years, 5 years after SADI-S and OAGBP surgery]

Eligibility criteria

Inclusion criteria

  • Patients over 18 and under 65 who meet criteria for bariatric surgery.
  • Maximum BMI between 45 and 50 kg/m2 and indication for surgery in a time
  • Signature of the informed consent of the study
  • Patients suitable for laparoscopic surgery

Exclusion criteria

  • Previous bariatric surgery
  • 2-stage surgery
  • Contraindication for hypoabsorptive surgery due to previous pathology: inflammatory bowel disease, transplant recipient or transplant candidate, previous intestinal resection surgery
  • Other associated surgical procedures in the same intervention.
  • Conversion to laparotomy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05948852 · 23/001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗