NCT07413237

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 10, 2026

Last Update Submit

February 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    Weight loss was recorded.

    1 month after the procedure

Secondary Outcomes (3)

  • Metabolic syndrome

    1 month after the procedure

  • Assessment of quality of life

    1 month after the procedure

  • Incidence of complications

    1 month after the procedure

Study Arms (2)

Group (A) (SASJ Group)

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

Procedure: Single anastomosis sleeve jejunal bypass

Group (B) (Lap Gastric Sleeve Group)

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

Procedure: Laparoscopic sleeve gastrectomy

Interventions

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

Group (A) (SASJ Group)

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

Group (B) (Lap Gastric Sleeve Group)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This comparative prospective cohort study was conducted in General surgery department, Ain Shams University Hospitals.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer in General Surgery, Ain Shams University, Cairo, Egypt.

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 17, 2026

Study Start

August 15, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations