Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-08-16
2025-02-01
Brief Summary
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The study will monitor the enteroendocrine function before and after the ingestion of a mixed meal, in pre-operatory and post-surgery timepoints, comparing both primary and revisional surgeries.
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Detailed Description
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However, the superobese patients (IMC≥ 50kg/m2) present variable weight loss resistance to the previous techniques, showing better results when submitted to disabsorptive procedures, namely the biliopancreatic diversion with duodenal switch, and the more recently created single anastomosis duodeno-ileal bypass. Each constitutes a revisional surgery option after a primary sleeve gastrectomy, reducing surgical and anesthesia risks. This has brought to light that some superobese patients do not need the revisional procedure as they achieve the weight loss target solely by the vertical gastrectomy.
Supported on the investigators' previous work and extensive experience performing both techniques, they now aim to understand the enteroendocrine physiological changes which each procedure accomplishes and compare them in terms of therapeutic efficacy among the superobese. The utmost goals will be to unravel the advantages of BPD-DS and SADI-S as primary or revisional surgeries, the differences between patients that respond well to sleeve gastrectomy alone and those who do not, and, finally, providing further insights on which procedure should be favoured over the other based on the patient characteristics.
Study Overview:
Participants in this study will have been submitted to either BPD-DS or SADI-S, as a primary or as a revisional surgery.
* Participants visits will be scheduled before surgery and after surgery at 3, 6 , 12 and 24 months for those who receive BPD-DS or SADI-S as a primary procedure.
* Those who are firstly submitted to the sleeve gastrectomy, visits will be scheduled before surgery and after surgery at 3 , 6 and 12 months. The revisional surgery will take place 1 year after the sleeve, with visits scheduled before surgery and after surgery at 3, 6 and 12 months.
In all these visits, detailed participants assessment will include vitals, anthropometric and biochemical evaluation, and the performance of a MMTT with plasma sampling for hormonal profiles. Intraoperative sampling of visceral and subcutaneous adipose tissue will take place during BPD-DS or SADI-S as a primary procedure and during the sleeve gastrectomy and repeated 1 year after the revisional surgery, either BPD-DS or SADI-S, is performed.
Participant Enrolment:
Participants will be selected from the cohort of patients referred for multidisciplinary evaluation by the clinical team for surgical treatment of obesity of the Centro Hospitalar Entre Douro e Vouga (CHEDV). Participants found to be suitable according to the entry criteria and who have accepted to participate will be enrolled in the study and assigned to one of the four study groups according to participants clinical features.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SADI-S as a primary surgery
Single anastomosis duodeno-ileal bypass
Sleeve gastrectomy followed by division of the duodenum bypassing the jejunum with end-to-side duodeno-ileal diversion
BPD-DS as a primary surgery
Biliopancreatic diversion with duodenal switch
Sleeve gastrectomy, followed by division of the duodenum bypassing the jejunum with end-to-side duedeno-ileal diversion and Roux-en-y entero-enteric anastomosis, leaving 100 cm common channel.
SADI-S as a revisional procedure
SADI-S as a revisional procedure
In patients previously submitted to sleeve gastrectomy a single anastomosis duodeno-ileal bypass will be performed as 2nd time surgery
BPD-DS as a revisional procedure
BPD-DS as a revisional procedure
In patients previously submitted to sleeve gastrectomy a biliopancreatic diversion with duodenal switch will be performed as 2nd time surgery
Interventions
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Single anastomosis duodeno-ileal bypass
Sleeve gastrectomy followed by division of the duodenum bypassing the jejunum with end-to-side duodeno-ileal diversion
Biliopancreatic diversion with duodenal switch
Sleeve gastrectomy, followed by division of the duodenum bypassing the jejunum with end-to-side duedeno-ileal diversion and Roux-en-y entero-enteric anastomosis, leaving 100 cm common channel.
SADI-S as a revisional procedure
In patients previously submitted to sleeve gastrectomy a single anastomosis duodeno-ileal bypass will be performed as 2nd time surgery
BPD-DS as a revisional procedure
In patients previously submitted to sleeve gastrectomy a biliopancreatic diversion with duodenal switch will be performed as 2nd time surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI between 45 and 55 kg/m2
* Aged between 18 and 65 years at surgery
Exclusion Criteria
* Diabetic patients (Hb A1c \> 5,7%) prior to the bariatric procedure
* Treatment with antidiabetic drugs, except for purposes other than diabetes treatment, prior to the bariatric procedure
18 Years
65 Years
ALL
No
Sponsors
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Instituto de Ciências Biomédicas Abel Salazar
OTHER
The Novo Nordisk Foundation Center for Basic Metabolic Research
OTHER
Hospital de Sao Sebastiao
OTHER
Responsible Party
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Marta Guimarães
Principal Investigator
Locations
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São Sebastião Hospital
Santa Maria da Feira, Aveiro District, Portugal
Hospital de São Sebastião
Santa Maria da Feira, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSS
Identifier Type: -
Identifier Source: org_study_id
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