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NCT Number: NCT05948852

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

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.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metabolic surgery (SADIS and OAGB)

Procedure

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 outcomes

  1. 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 outcomes

  1. % of patients with gastroesophageal reflux (acid and bile) after surgery

    Time frame: 1 year, 3 year, 5 year after SADI-S and OAGBP surgery

  2. Number of deaths in the immediate postoperative period

    Time frame: up to day 90 post-intervention

  3. Number of Participants with complications in the immediate postoperative period

    Time frame: up to day 90 post-intervention

  4. Ratio of patients with more than 3 loose stools per day

    Time frame: 1 year, 3 years, 5 years after the surgery

    The ratio of patients with more than 3 loose stools per day will be evaluated as pathological. To assess the quality of the bowel movements, the Bristol Stool Form Scale questionnaire will be used. An evaluation of the number of bowel movements and their quality according to the Bristol Stool Form Scale questionnaire will be conducted at 1 year, 3 years, and 5 years after the surgery

  5. questionnaire of quality of life

    Time frame: 1 year, 3 years, 5 years after SADI-S and OAGBP surgery

    The quality of life will be assessed based on the results of the Moorehead-Ardelt II test and the Medical Outcomes Study Short Form-36 questionnaire. The Moorehead-Ardelt II questionnaire includes 6 parameters related to self-esteem, physical activity, social contact, job satisfaction, sexual pleasure, and eating habits. The minimum score is -3 and the maximum is +3. A score of 1.1 to 2 is considered a good result, and anything above 2.1 is considered very good.

    The SF-36 questionnaire includes 8 parameters such as physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The minimum score is 0 and the maximum is 100.

  6. Number of patients with nutritional deficiencies

    Time frame: 1 year, 3 years, 5 years after SADI-S and OAGBP surgery

    The main nutritional deficiencies to be evaluated after OAGB (One Anastomosis Gastric Bypass) and SADIS (Single Anastomosis Duodeno-Ileal Switch) are iron and/or vitamin B12 deficiency anemia, deficiencies in fat-soluble vitamins, calcium, and trace elements.

    The incidence of nutritional deficiencies will be assessed through routine blood tests at 1 year, 3 years, and 5 years after the surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Sergio Sanchez Cordero, MD

CONTACT

[email protected]

+34 93 553 12 00 ext. 8902

Sponsors and collaborators

Lead sponsor

Consorci Sanitari Integral

Other

Registry information

Official study 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)

Acronym: OASIS

Important dates

Study start
2023
Primary completion
2024
Study completion
2029
First posted
Jul 17, 2023
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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