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Efficacy of SASI Bypass for Type-2 Diabetic Obese Patients

Efficacy of Single Anastomosis Sleeve Ileal (SASI) Bypass for Type-2 Diabetic Obese Patients: Loop Gastric Bipartition, a Novel Metabolic Surgery Procedure.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02680873
Acronym
SASI
Enrollment
50
Registered
2016-02-12
Start date
2013-03-31
Completion date
2015-12-31
Last updated
2016-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2 in Obese

Keywords

type 2 diabetes , obesity , SASI

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.

Detailed description

All patients were subjected to thorough history, clinical examination and laboratory investigations including basic preoperative investigations, lipid profile, thyroid and suprarenal hormonal evaluation. In addition, patients may undergo further assessment for pulmonary functions or gastroesophageal disease including endoscope. . Abdominal ultrasound was done to exclude calcular cholecystitis and to evaluate the degree of fatty liver. Reduction the size of fatty liver was done by putting all patients on low-calorie protein diet for 6 weeks. Deep vein thrombosis prophylaxis started 12 h before surgery with low molecular weight heparin subcutaneous injections . Preoperative data included age, gender, initial weight, initial body mass index (BMI), obesity comorbidities and treatment medications used (chest problems, diabetes, arterial hypertension and cardiac ischaemia, hyperlipidemia, obstructive sleep apnea syndrome, gall stones, urinary stress incontinence, joint pain, depression, infertility and heart burn). Postoperative data included hospital stay, early postoperative complications during the first month (e.g. fever, collection, bleeding, vomiting, leak and port site problems .Long-term complications more than 1 month after surgery (e.g. nausea, vomiting, reflux, stricture, intestinal obstruction , hypoalbuminemia , anemia and calcium or iron or vitamin D , vitamin B12 deficiency and), excess weight loss and BMI were collected.

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.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Healthy volunteers
No

Inclusion criteria

Type 2 diabetic obese pateints -

Exclusion criteria

patients age above 65 or below 18 years old, history of upper laparotomy, unfit for anesthesia or laparoscopy, major psychological instability and drug abuse. \-

Design outcomes

Primary

MeasureTime frameDescription
excess weight lossone yearThe percent of excess weight loss was calculated as follows: \[(preoperative weight-follow up weight)/preoperative excess weight\] ×100.
resolution of diabetesone yearResolution 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026