Efficacy of SASI Bypass for Type-2 Diabetic Obese Patients
SASI
Efficacy of Single Anastomosis Sleeve Ileal (SASI) Bypass for Type-2 Diabetic Obese Patients: Loop Gastric Bipartition, a Novel Metabolic Surgery Procedure.
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
the investigator modified the Sanator's operation by performing a loop rather than Roux-en-Y bipartition reconstruction and the investigator are reporting the first clinical results of the outcomes of SASI bypass as a mode of functional restrictive and neuroendocrine modulation therapeutic option for obese type 2 diabetes mellituspatients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2013
Typical duration for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 7, 2016
CompletedFirst Posted
Study publicly available on registry
February 12, 2016
CompletedFebruary 12, 2016
February 1, 2016
2.8 years
February 7, 2016
February 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
excess weight loss
The percent of excess weight loss was calculated as follows: \[(preoperative weight-follow up weight)/preoperative excess weight\] ×100.
one year
resolution of diabetes
Resolution of diabetes was defined in this study as a fasting plasma glucose level \< 110 mg/dL or HbA1C level \< 6 % without hypoglycemic medication at 1 year after surgery. whereas improvement was defined as a reduction of at least 25% in the fasting plasma glucose level and of at least 1% in the hemoglobin A1c level with hypoglycemic drug treatment
one year
Study Arms (1)
SASI bypass
OTHERsleeve gastrectomy done and gastro-ileum anastomosis 2.5 meter from the ileocecal valve . the anastomosis is less than 3cmm in diameter . the concept to push undigested food early to the ileum to stimulate intestinal hormones secretion to control diabetes .
Interventions
he operation was done under general anesthesia. The technique commences with the devascularization of the greater curvature of the stomach with the harmonic scalpel.junction. The stomach is then tubularized over a 36 French calibration tube, with a linear stapler charged with a green cartridge, commencing 6 cm proximal to the pylorus. The ileocecal junction is identified and 250 cm is measured upwards. The selected loop is ascended antecolic without division of the greater omentum, and a stapled isoperistaltic side-to-side to the anterior wall of the antrum of the stomach just cranial 3 cm away from the pylorus with a linear stapler charged with a green cartridge.
Eligibility Criteria
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Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor of surgery
Study Record Dates
First Submitted
February 7, 2016
First Posted
February 12, 2016
Study Start
March 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 12, 2016
Record last verified: 2016-02