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Outcomes of Single Anastomosis Sleeve Jejunal Bypass (SAS-J) VS Sleeve Gastrectomy

A

Ain Shams University

Status

Completed

Conditions

Single Anastomosis Sleeve Jejunal Bypass
Sleeve Gastrectomy

Treatments

Procedure: Laparoscopic sleeve gastrectomy
Procedure: Single anastomosis sleeve jejunal bypass

Study type

Observational

Funder types

Other

Identifiers

NCT07413237
13/8/2023.

Details and patient eligibility

About

The aim of this work is to compare the outcomes of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with sleeve gastrectomy as regards efficacy including sustained weight loss, metabolic syndrome, quality of life, complications and associated comorbidities in morbid obese.

Full description

The most commonly performed bariatric surgery worldwide is the vertical sleeve gastrectomy (VSG), the Roux-en-Y gastric bypass (RYGB), and the One anastomosis (Mini) gastric bypass, which has been demonstrated to produce excellent bariatric and metabolic outcomes.

Single anastomosis sleeve ileal (SASI) bypass was introduced in 2015 as a modification of Santorini's operation in, as it keeps pass to the duodenum so the biliary tree and the whole gut and can be assessed by the endoscope; there are no blind loops, excluded segments or foreign bodies.

Enrollment

80 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients age from 18 to 60 years old.
  • Both sexes.
  • Patients with body mass index (BMI) ≥ 40.
  • Patients with BMI (35 - 40) with obesity related comorbidities. (e.g. type 2 diabetes mellitus, obstructive sleep apnea, hypertension, hyperlipidemia, obesity hypoventilation syndrome, non-alcoholic fatty liver disease, gastroesophageal reflux disease and severe arthritis).
  • Able to be committed to follow-up.

Exclusion criteria

  • Patients underwent previous Bariatric surgeries.
  • Patients with severe systemic disease, such as congestive heart failure - unstable angina - recent stroke or myocardial infarction less than 3 months ago. Contraindications for insufflation as those with severe cardiovascular or severe restrictive respiratory diseases.
  • Patients that refused to participate in the study.
  • Patients with psychiatric illness.
  • Preoperative upper GI endoscopy findings of GERD class C and Barrett's oesophagus
  • Previous upper GIT surgery or liver cirrhosis.
  • Patients on oral steroid therapy.
  • Not fit for general anaesthesia (e.g. patients with severe heart disease or untreatable coagulopathies).
  • Significant abdominal adhesions.
  • Major psychiatric illness.
  • Pregnant patients.

Trial design

80 participants in 2 patient groups

Group (A) (SASJ Group)
Description:
Patients underwent single anastomosis sleeve jejunal bypass as a metabolic and weight loss surgery.
Treatment:
Procedure: Single anastomosis sleeve jejunal bypass
Group (B) (Lap Gastric Sleeve Group)
Description:
Patients underwent laparoscopic sleeve gastrectomy(LGS) as a metabolic and weight loss surgery.
Treatment:
Procedure: Laparoscopic sleeve gastrectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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