Morbid Obesity Requiring Bariatric SurgeryNCT07087535
Midterm Follow up Outcomes of (SASJ) in Management of Morbid Obesity
An observational study of Morbid Obesity Requiring Bariatric Surgery, run by Sohag University at 1 site in Egypt.
Trial summary
Obesity is a critical health problem associated with an increased risk of cardiovascular disease, diabetes, and cancers, affecting both the quality of life and life expectancy . The increasing prevalence of obesity and comorbid conditions requires effective treatment and prevention . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity Requiring Bariatric Surgery
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sohag University Hospitals
Who may be able to join
- Age from 18 to 65 years old.
- Both sexes.
- Body mass index (BMI) > 35 with comorbidities or BMI > 40 with or without comorbidities.
- Primary bariatric procedure.
- Follow up period 2 years or more after SASJ.
Who cannot join
- Follow up period less than 2 years.
- Previous laparoscopic metabolic surgery
- Patients with huge anterior abdominal wall hernias.
- Cirrhotic patients.
- Pregnant or lactating females.
- Unfit patients for anesthesia.
- patients requiring revisional bariatric surgery.
- Patients with any contraindications to laparoscopic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Midterm Follow up Outcomes of Single Anastomosis Sleeve Jejunal Bypass (SASJ) in Management of Morbid Obesity
Obesity is a critical health problem associated with an increased risk of cardiovascular disease, diabetes, and cancers, affecting both the quality of life and life expectancy . The increasing prevalence of obesity and comorbid conditions requires effective treatment and prevention . Previous evidence has demonstrated that bariatric surgery is associated with greater and longer-term weight loss than non-surgical management Thus, in patients with a body mass index of ≥ 40 or ≥ 35 kg/m2 with co-morbidities, bariatric surgery is the most effective treatment option that not only promotes weight loss but also improves comorbid conditions . However, like any surgical procedure, several complications can occur . The development of nutritional deficiencies is a complication which may be life-threatening; therefore, bariatric surgery requires careful consideration .
The most frequently performed surgery for obesity worldwide is the laparoscopic sleeve gastrectomy (LSG), the Roux-en-Y gastric bypass (RYGB), and more recently, the one anastomosis gastric bypass (OAGB) .
Read more
One newly developed weight loss procedure, the single sleeve ileal anastomosis bypass (SASI), has been developed as a modification to Santoro's operation (sleeve gastrectomy with transit bipartition SG + TB) . Since no duodenal division or manual anastomosis is required, the procedure allows easy endoscopic access to the duodenum . noted that SASI has the following advantages over other bariatric procedures: SASI has a shorter operative time compared to other procedures; 2) easy access to the duodenum and biliary tree endoscopically; 3) SASI does not divide the duodenum, thus eliminating the possibility of duodenal stump leakage, a serious complication with an incidence range between; 4) the tension on the anastomosis lower than other techniques; 5) there are no blind loops, excluded segments, or foreign bodies; 6) SASI is completely reversible .
Single anastomosis sleeve jejunal (SASJ) bypass, which is the focus of this study, is a modification of SASI using a shorter biliopancreatic limb length compared to SASI to prevent long-term nutritional complications . The SASJ bypass appears to be safer than the SASI procedure in patients with excessive weight loss and nutritional deficiencies and is simpler due to its improved surgical ergonomics .
Aim of the Work This study aims to evaluate the three-year outcomes of SASJ bypass as a primary bariatric procedure in a tertiary bariatric center for weight loss, comorbidity resolution, and both early and late complications.
Read the detailed description
A retrospective study with prospective collected data included a case series of consecutive bariatric patients who underwent SASJ bypass in Sohag university hospitals between the 1st of January 2019 and the 31st of june 2023. The analysis in the present study included data of all the patients who underwent SASJ as bariatric procedure. All patients were approved as candidates for bariatric surgery by a multidisciplinary screening team, between 18 and 65 years of age and a BMI more than 40 kg/m2 or BMI of more than 35 kg/m2 combined with comorbidities.
All the required data have been collected from the patients' files at Sohag university hospitals out-patient clinic. To update follow up data for missing patients, a postal questionnaire will be sent to all patients to retrieve the latest outcome. Patients who will not respond will receive a phone call and email if applicable. The postal questionnaire contained questions about:
- Current and lowest weight after surgery.
- Current comorbidities and medication.
- Possible complaints / complications.
- Any surgical intervention related to the SASJ bypass. In case of non-response, the data of the last visit either in hospital or out-patient clinic were used as a final outcome.
- Keywords
- obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss outcomes
- Percentage of excess weight loss
- Percentage of total weight loss
Measured: 2 years
Secondary outcomes (1)
comorbidities readmission reoperation
- Comorbidity resolution
- readmission
- reoperation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Jun 2019
- Primary completion30 Jun 2023
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid Obesity Requiring Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case-control
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Sayed Khalaf, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087535
- Sponsor's protocol ID
- Soh-Med--25-6-9MS
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midterm Follow up Outcomes of Single Anastomosis Sleeve Jejunal Bypass (SASJ) in Management of Morbid Obesity
- ClinicalTrials.gov ID
- NCT07087535
- Acronym / sponsor ID
- Soh-Med--25-6-9MS
- Keywords
- obesity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 Jul 2025 (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.
Obesity is a critical health problem associated with an increased risk of cardiovascular disease, diabetes, and cancers, affecting both the quality of life and life expectancy . The increasing prevalence of obesity and comorbid conditions requires effective treatment and prevention . Previous evidence has demonstrated that bariatric surgery is associated with greater and longer-term weight loss than non-surgical management Thus, in patients with a body mass index of ≥ 40 or ≥ 35 kg/m2 with co-morbidities, bariatric surgery is the most effective treatment option that not only promotes weight loss but also improves comorbid conditions . However, like any surgical procedure, several complications can occur . The development of nutritional deficiencies is a complication which may be life-threatening; therefore, bariatric surgery requires careful consideration .
The most frequently performed surgery for obesity worldwide is the laparoscopic sleeve gastrectomy (LSG), the Roux-en-Y gastric bypass (RYGB), and more recently, the one anastomosis gastric bypass (OAGB) .
One newly developed weight loss procedure, the single sleeve ileal anastomosis bypass (SASI), has been developed as a modification to Santoro's operation (sleeve gastrectomy with transit bipartition SG + TB) . Since no duodenal division or manual anastomosis is required, the procedure allows easy endoscopic access to the duodenum . noted that SASI has the following advantages over other bariatric procedures: SASI has a shorter operative time compared to other procedures; 2) easy access to the duodenum and biliary tree endoscopically; 3) SASI does not divide the duodenum, thus eliminating the possibility of duodenal stump leakage, a serious complication with an incidence range between; 4) the tension on the anastomosis lower than other techniques; 5) there are no blind loops, excluded segments, or foreign bodies; 6) SASI is completely reversible .
Single anastomosis sleeve jejunal (SASJ) bypass, which is the focus of this study, is a modification of SASI using a shorter biliopancreatic limb length compared to SASI to prevent long-term nutritional complications . The SASJ bypass appears to be safer than the SASI procedure in patients with excessive weight loss and nutritional deficiencies and is simpler due to its improved surgical ergonomics .
Aim of the Work This study aims to evaluate the three-year outcomes of SASJ bypass as a primary bariatric procedure in a tertiary bariatric center for weight loss, comorbidity resolution, and both early and late complications.
Detailed description
A retrospective study with prospective collected data included a case series of consecutive bariatric patients who underwent SASJ bypass in Sohag university hospitals between the 1st of January 2019 and the 31st of june 2023. The analysis in the present study included data of all the patients who underwent SASJ as bariatric procedure. All patients were approved as candidates for bariatric surgery by a multidisciplinary screening team, between 18 and 65 years of age and a BMI more than 40 kg/m2 or BMI of more than 35 kg/m2 combined with comorbidities.
All the required data have been collected from the patients' files at Sohag university hospitals out-patient clinic. To update follow up data for missing patients, a postal questionnaire will be sent to all patients to retrieve the latest outcome. Patients who will not respond will receive a phone call and email if applicable. The postal questionnaire contained questions about:
- Current and lowest weight after surgery.
- Current comorbidities and medication.
- Possible complaints / complications.
- Any surgical intervention related to the SASJ bypass. In case of non-response, the data of the last visit either in hospital or out-patient clinic were used as a final outcome.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sohag University Hospitals
Key inclusion criteria (5 listed)
- Age from 18 to 65 years old.
- Both sexes.
- Body mass index (BMI) > 35 with comorbidities or BMI > 40 with or without comorbidities.
- Primary bariatric procedure.
- Follow up period 2 years or more after SASJ.
Key exclusion criteria (8 listed)
- Follow up period less than 2 years.
- Previous laparoscopic metabolic surgery
- Patients with huge anterior abdominal wall hernias.
- Cirrhotic patients.
- Pregnant or lactating females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
weight loss outcomes
Time frame: 2 years
* Percentage of excess weight loss * Percentage of total weight loss
1 secondary outcome
comorbidities readmission reoperation
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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 Morbid Obesity Requiring Bariatric Surgery, run by Sohag 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 8 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 outcomes (time frame: 2 years). 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 28 Jul 2025.