Health TrialsbyHealthPanel

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

ConditionObesity, Morbid
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorConsorci Sanitari Integral

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • metabolic surgery (SADIS and OAGB)

    Procedure/Surgery

    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).

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Group A: SADI-SExperimental treatment 1 intervention
Group B: Group B: OAGBActive comparator 1 intervention

Trial outcomes

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

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Consorci Sanitari Integral

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: