Single Anastomosis Sleeve Jejunal BypassNCT07413237
Outcomes of Single Anastomosis Sleeve Jejunal Bypass (SAS-J) VS Sleeve Gastrectomy
An observational study of Single Anastomosis Sleeve Jejunal Bypass and Sleeve Gastrectomy, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Single Anastomosis Sleeve Jejunal Bypass, Sleeve Gastrectomy
- What is being tested?
- Single anastomosis sleeve jejunal bypass and Laparoscopic sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2023to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This comparative prospective cohort study was conducted in General surgery department, Ain Shams University Hospitals.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparative Study Evaluating the 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.
Read the detailed 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.
- Being tested
- Single anastomosis sleeve jejunal bypass, Laparoscopic sleeve gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single anastomosis sleeve jejunal bypassProcedure or surgery
Patients underwent single anastomosis sleeve jejunal bypass as a metabolic and weight loss surgery.
Laparoscopic sleeve gastrectomyProcedure or surgery
Patients underwent laparoscopic sleeve gastrectomy (LGS) as a metabolic and weight loss surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) (SASJ Group) | Patients underwent single anastomosis sleeve jejunal bypass as a metabolic and weight loss surgery. Receives: 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. Receives: Procedure: Laparoscopic sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight loss was recorded.
Measured: 1 month after the procedure
Secondary outcomes (3)
Metabolic syndrome
Metabolic syndrome was recorded.
Measured: 1 month after the procedure
Assessment of quality of life
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.
Measured: 1 month after the procedure
Incidence of complications
Incidence of complications such as gastroesophageal reflux disease (GERD), bile reflux, gall stones, reoperations, and postoperative bleeding were recorded.
Measured: 1 month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start15 Aug 2023
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Anastomosis Sleeve Jejunal BypassStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riham AbdelNasser gad sayed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413237
- Sponsor's protocol ID
- 13/8/2023.
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study Evaluating the Outcomes of Single Anastomosis Sleeve Jejunal Bypass (SAS-J) VS Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT07413237
- Acronym / sponsor ID
- 13/8/2023.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) (SASJ Group) | – | Procedure: Single anastomosis sleeve jejunal bypassPatients underwent single anastomosis sleeve jejunal bypass as a metabolic and weight loss surgery. |
| Group (B) (Lap Gastric Sleeve Group) | – | Procedure: Laparoscopic sleeve gastrectomyPatients underwent laparoscopic sleeve gastrectomy(LGS) as a metabolic and weight loss surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This comparative prospective cohort study was conducted in General surgery department, Ain Shams University Hospitals.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single anastomosis sleeve jejunal bypassPatients underwent single anastomosis sleeve jejunal bypass as a metabolic and weight loss surgery. | Procedure or surgery | Group (A) (SASJ Group) |
| Laparoscopic sleeve gastrectomyPatients underwent laparoscopic sleeve gastrectomy (LGS) as a metabolic and weight loss surgery. | Procedure or surgery | Group (B) (Lap Gastric Sleeve Group) |
Primary outcome
Weight loss
Time frame: 1 month after the procedure
Weight loss was recorded.
3 secondary outcomes
Metabolic syndrome
Time frame: 1 month after the procedure
Assessment of quality of life
Time frame: 1 month after the procedure
Incidence of complications
Time frame: 1 month after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Single Anastomosis Sleeve Jejunal Bypass
Active, not recruitingObservational study
Midterm Follow up Outcomes of (SASJ) in Management of Morbid Obesity
Morbid Obesity Requiring Bariatric Surgery
Not yet recruiting
Single Anastomosis Sleeve Jejunal Bypass Versus One Anastomosis Gastric Bypass in Management of Morbid Obese Patients: A Comparative Study
Single Anastomosis Sleeve Jejunal Bypass
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single Anastomosis Sleeve Jejunal Bypass and Sleeve Gastrectomy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 1 month after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.