Single Anastomosis Sleeve Jejunal BypassNCT06857097
Single Anastomosis Sleeve Jejunal Bypass Versus One Anastomosis Gastric Bypass in Management of Morbid Obese Patients: A Comparative Study
A study testing single anastomosis sleeve jejunal bypass and One anastomosis gastric bypass in people with Single Anastomosis Sleeve Jejunal Bypass, run by Sohag University at 1 site in Egypt.
Trial summary
This study was conducted aiming to assess the efficacy of SASJ bypass as a novel bariatric procedure in terms of operative time, weight loss, complications and effect on comorbidities compared to the outcomes of OAGB within two years after operation. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Single Anastomosis Sleeve Jejunal Bypass
- What is being tested?
- single anastomosis sleeve jejunal bypass and One anastomosis gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Mar 2027
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- body mass index of over 35 plus the comorbidity presence.
- body mass index of over 40 with/without comorbidity.
- patients' willingness to participate in the study.
- patients' cooperation in follow-up researches.
- lacking any psychiatric disease.
Who cannot join
- Patients negating to change their lifestyle.
- drug abuse and/or addiction.
- eating disorder background (e.g., bulimia nervosa).
- Patients with contraindications to laparoscopic surgery and (or) unfit for surgery.
- pregnant patients.
- previous upper abdominal procedures,
- reflux symptoms
- major unstable psychiatric illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study was conducted aiming to assess the efficacy of SASJ bypass as a novel bariatric procedure in terms of operative time, weight loss, complications and effect on comorbidities compared to the outcomes of OAGB within two years after operation.
Read the detailed description
This study is going to be prospectively randomized. There will be one hundred people with morbid obesity undergoing bariatric surgery at the hospitals of Sohag University and Ainshams University. The investigator will select which individuals will have gastric bypass surgery after counseling patients about all bariatric procedures. The patients were randomly assigned to two equal groups (50 per group); the first patient was OAGB (group A), and the second was SASJ (group B). After the study has been approved by the ethics council of the Sohag University and Ain shams university, Faculty of Medicine, all patients must give written informed consent for participation.
the investigators included a total of 100 cases in this prospective randomized study, and they were divided into two equal groups; SASJ and OAGB groups. The two procedures were performed by the same surgical team adapting standardized techniques. Weight loss parameters were our primary objectives, while secondary outcomes included operative time ,post-operative complications, nutritional(macro and micro nutrients) status, improvement/resolution of comorbidities and quality of life.
Total number of 100 patients, aged between 16 and 60 years, with BMI > 40 kg/m2, or BMI > 35 kg/m2 with the presence of obesity related comorbidity (diabetes mellitus, hypertension, OSAS, osteoarthritis) were enrolled in this study.
An informed written consent was signed by all patients, after complete explanation of the idea of the study, along with the benefits and drawbacks of each procedure. Detailed history taking, physical examination, routine preoperative laboratory investigations and abdominal ultrasonography were performed for all cases.
The 100 cases were randomly allocated into two equal groups SASJ and OAGB groups. Randomization was done in the operating room . All cases were performed by laparoscopy under general anesthesia. The two procedures were performed by 5 ports, .
For the SASJ group , sleeve was created starting devascularization of greater gastric curve 6 cm proximal to pylorus. Devascularization was done via either a harmonic scalpel or a ligasure device. Dissection was continued proximally till reaching the left diaphragmatic crus. Afterwards that the stomach was resected along the greater curvature via an endostapler over a 36-Fr bougie. After creating the sleeve, two meters of the small bowel were counted starting from the ligament of Treitz, and an antecolic isoperistaltic gastrojejunostomy (4-cm wide) was created with the antrum via linear stapler, and the anterior wall defect was closed by sutures.
In the OAGB group .dissection started just distal to the crows' foot till reaching the lesser sac. A long narrow gastric pouch was created by the endostapler. After that, a longitudinal gastrojejunostomy (4-cm wide) was created at 200 cm distal to the Treitz ligament as the SASJ group.
For all procedures, intraoperative methylene blue test was done and an abdominal drain was inserted at the gastric staple line. After operation, all cases were transferred to the internal ward, and started oral intake 6 hours after surgery. Most cases were discharged on the 1st or 2nd post operative day after fully mobilized and appropriate oral intake. Patients were recommended to receive a liquid diet for the first week, followed by soft diet for the following three weeks. There after, a long-term solid diet (hypo-caloric, protein-enriched) was recommended. Daily oral supplements of multivitamins and weekly administration of the intramuscular vitamin B12 were commenced for all cases.
Regular follow up was scheduled for all cases for weekly in the first month then 3, 6 , 12 , 24 months after surgery. During these visits, patients were clinically and biochemically assessed. Any post-operative complications were noted and recorded. Weight changes were recorded as the percentage of excess weight loss (%EWL) and percentage of total weight loss (%TWL).
Our primary outcomes were the %EWL and %TWL, while secondary outcomes included post-operative complications, improvement/resolution of comorbidities.. Diabetes resolution was defined according to Buse et al. as the presence of normal glucose and Hba1c levels in the absence of antidiabetic medications [23], whereas resolution of OSAS was defined by STOPBANG questionnaire with score less than 2 after operation [24]. Hypertension improvement was defined as blood pressure < 140/90 with reduction of medication dose and remission without its cessation [25]. De novo GERD was defined as the post-operative development of reflux symptoms in patients not suffering from it [26], and reflux was confirmed by endoscopy in these cases.
- Conditions
- Single Anastomosis Sleeve Jejunal Bypass
- Being tested
- single anastomosis sleeve jejunal bypass, One anastomosis gastric bypass
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
sleeve was created starting devascularization of greater gastric curve 6 cm proximal to pylorus. Devascularization was done via either a harmonic scalpel or a ligasure device. Dissection was continued proximally till reaching the left diaphragmatic crus. Afterwards that the stomach was resected along the greater curvature via an endostapler over a 36-Fr bougie. After creating the sleeve, two meters of the small bowel were counted starting from the ligament of Treitz, and an antecolic isoperistaltic gastrojejunostomy (4-cm wide) was created with the antrum via linear stapler, and the anterior wall defect was closed by sutures.
One anastomosis gastric bypassProcedure or surgery
dissection started just distal to the crows' foot till reaching the lesser sac. A long narrow gastric pouch was created by the endostapler. After that, a longitudinal gastrojejunostomy (4-cm wide) was created at 200 cm distal to the Treitz ligament as the SASJ group.
| Study group | Role | What they receive |
|---|---|---|
| single anastomosis sleeve jejunal bypass group | Active comparator | Not described Receives: Procedure: single anastomosis sleeve jejunal bypass |
| one anastomosis gastric bypass | Active comparator | dissection started just distal to the crows' foot till reaching the lesser sac. A long narrow gastric pouch was created by the endostapler. After that, a longitudinal gastrojejunostomy (4-cm wide) was created at 200 cm distal to the Treitz ligament as the SASJ grou p. Receives: Procedure: One anastomosis gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss parameters
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 posted4 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Mar 2027 (estimated)
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Gamal Abdelraoof, Sohag University
- Investigators
- sohag university hospital, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857097
- Sponsor's protocol ID
- Soh-Med-25-2-4MD
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Anastomosis Sleeve Jejunal Bypass Versus One Anastomosis Gastric Bypass in Management of Morbid Obese Patients: A Comparative Study
- ClinicalTrials.gov ID
- NCT06857097
- Acronym / sponsor ID
- Soh-Med-25-2-4MD
- Conditions
- Single Anastomosis Sleeve Jejunal Bypass
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Mar 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.
This study was conducted aiming to assess the efficacy of SASJ bypass as a novel bariatric procedure in terms of operative time, weight loss, complications and effect on comorbidities compared to the outcomes of OAGB within two years after operation.
Detailed description
This study is going to be prospectively randomized. There will be one hundred people with morbid obesity undergoing bariatric surgery at the hospitals of Sohag University and Ainshams University. The investigator will select which individuals will have gastric bypass surgery after counseling patients about all bariatric procedures. The patients were randomly assigned to two equal groups (50 per group); the first patient was OAGB (group A), and the second was SASJ (group B). After the study has been approved by the ethics council of the Sohag University and Ain shams university, Faculty of Medicine, all patients must give written informed consent for participation.
the investigators included a total of 100 cases in this prospective randomized study, and they were divided into two equal groups; SASJ and OAGB groups. The two procedures were performed by the same surgical team adapting standardized techniques. Weight loss parameters were our primary objectives, while secondary outcomes included operative time ,post-operative complications, nutritional(macro and micro nutrients) status, improvement/resolution of comorbidities and quality of life.
Total number of 100 patients, aged between 16 and 60 years, with BMI > 40 kg/m2, or BMI > 35 kg/m2 with the presence of obesity related comorbidity (diabetes mellitus, hypertension, OSAS, osteoarthritis) were enrolled in this study.
An informed written consent was signed by all patients, after complete explanation of the idea of the study, along with the benefits and drawbacks of each procedure. Detailed history taking, physical examination, routine preoperative laboratory investigations and abdominal ultrasonography were performed for all cases.
The 100 cases were randomly allocated into two equal groups SASJ and OAGB groups. Randomization was done in the operating room . All cases were performed by laparoscopy under general anesthesia. The two procedures were performed by 5 ports, .
For the SASJ group , sleeve was created starting devascularization of greater gastric curve 6 cm proximal to pylorus. Devascularization was done via either a harmonic scalpel or a ligasure device. Dissection was continued proximally till reaching the left diaphragmatic crus. Afterwards that the stomach was resected along the greater curvature via an endostapler over a 36-Fr bougie. After creating the sleeve, two meters of the small bowel were counted starting from the ligament of Treitz, and an antecolic isoperistaltic gastrojejunostomy (4-cm wide) was created with the antrum via linear stapler, and the anterior wall defect was closed by sutures.
In the OAGB group .dissection started just distal to the crows' foot till reaching the lesser sac. A long narrow gastric pouch was created by the endostapler. After that, a longitudinal gastrojejunostomy (4-cm wide) was created at 200 cm distal to the Treitz ligament as the SASJ group.
For all procedures, intraoperative methylene blue test was done and an abdominal drain was inserted at the gastric staple line. After operation, all cases were transferred to the internal ward, and started oral intake 6 hours after surgery. Most cases were discharged on the 1st or 2nd post operative day after fully mobilized and appropriate oral intake. Patients were recommended to receive a liquid diet for the first week, followed by soft diet for the following three weeks. There after, a long-term solid diet (hypo-caloric, protein-enriched) was recommended. Daily oral supplements of multivitamins and weekly administration of the intramuscular vitamin B12 were commenced for all cases.
Regular follow up was scheduled for all cases for weekly in the first month then 3, 6 , 12 , 24 months after surgery. During these visits, patients were clinically and biochemically assessed. Any post-operative complications were noted and recorded. Weight changes were recorded as the percentage of excess weight loss (%EWL) and percentage of total weight loss (%TWL).
Our primary outcomes were the %EWL and %TWL, while secondary outcomes included post-operative complications, improvement/resolution of comorbidities.. Diabetes resolution was defined according to Buse et al. as the presence of normal glucose and Hba1c levels in the absence of antidiabetic medications [23], whereas resolution of OSAS was defined by STOPBANG questionnaire with score less than 2 after operation [24]. Hypertension improvement was defined as blood pressure < 140/90 with reduction of medication dose and remission without its cessation [25]. De novo GERD was defined as the post-operative development of reflux symptoms in patients not suffering from it [26], and reflux was confirmed by endoscopy in these cases.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single anastomosis sleeve jejunal bypass group | Active comparator | Procedure: single anastomosis sleeve jejunal bypass |
| one anastomosis gastric bypass | Active comparator | Procedure: One anastomosis gastric bypassdissection started just distal to the crows' foot till reaching the lesser sac. A long narrow gastric pouch was created by the endostapler. After that, a longitudinal gastrojejunostomy (4-cm wide) was created at 200 cm distal to the Treitz ligament as the SASJ grou p. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- body mass index of over 35 plus the comorbidity presence.
- body mass index of over 40 with/without comorbidity.
- patients' willingness to participate in the study.
- patients' cooperation in follow-up researches.
- lacking any psychiatric disease.
Key exclusion criteria (8 listed)
- Patients negating to change their lifestyle.
- drug abuse and/or addiction.
- eating disorder background (e.g., bulimia nervosa).
- Patients with contraindications to laparoscopic surgery and (or) unfit for surgery.
- pregnant patients.
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 bypasssleeve was created starting devascularization of greater gastric curve 6 cm proximal to pylorus. Devascularization was done via either a harmonic scalpel or a ligasure device. Dissection was continued proximally till reaching the left diaphragmatic crus. Afterwards that the stomach was resected along the greater curvature via an endostapler over a 36-Fr bougie. After creating the sleeve, two meters of the small bowel were counted starting from the ligament of Treitz, and an antecolic isoperistaltic gastrojejunostomy (4-cm wide) was created with the antrum via linear stapler, and the anterior wall defect was closed by sutures. | Procedure or surgery | single anastomosis sleeve jejunal bypass group |
| One anastomosis gastric bypassdissection started just distal to the crows' foot till reaching the lesser sac. A long narrow gastric pouch was created by the endostapler. After that, a longitudinal gastrojejunostomy (4-cm wide) was created at 200 cm distal to the Treitz ligament as the SASJ group. | Procedure or surgery | one anastomosis gastric bypass |
Primary outcome
Weight loss parameters
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 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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
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.
sohag university hospital principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single anastomosis sleeve jejunal bypass and One anastomosis gastric bypass in people with Single Anastomosis Sleeve Jejunal Bypass, 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: opening soon, as of the sponsor's last update on 11 Mar 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?
Contact Ashraf gamal (01019472023, ashraf_mohamed1@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss parameters (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 11 Mar 2025.