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Completed

NCT Number: NCT07413237

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, 11591, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single anastomosis sleeve jejunal bypass

Procedure

Patients underwent single anastomosis sleeve jejunal bypass as a metabolic and weight loss surgery.

Laparoscopic sleeve gastrectomy

Procedure

Patients underwent laparoscopic sleeve gastrectomy (LGS) as a metabolic and weight loss surgery.

Primary outcomes

  1. Weight loss

    Time frame: 1 month after the procedure

    Weight loss was recorded.

Secondary outcomes

  1. Metabolic syndrome

    Time frame: 1 month after the procedure

    Metabolic syndrome was recorded.

  2. Assessment of quality of life

    Time frame: 1 month after the procedure

    quality of life was assessed using specific scoring system is a variation of the BAROS (Bariatric Analysis and Reporting Outcome System). The specific tiers you listed (High, Moderate, and Mild Improvement)

    • High Improvement excess Weight Loss (%EWL) >50% + comorbidity resolution + no complications.
    • Moderate Improvement EWL 30-50% + partial comorbidity resolution.
    • Mild Improvement EWL <30% + no major issues.
  3. Incidence of complications

    Time frame: 1 month after the procedure

    Incidence of complications such as gastroesophageal reflux disease (GERD), bile reflux, gall stones, reoperations, and postoperative bleeding were recorded.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Prospective Comparative Study Evaluating the Outcomes of Single Anastomosis Sleeve Jejunal Bypass (SAS-J) VS Sleeve Gastrectomy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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