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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Egypt1 site
  • Sohag University

    Sohag

    Magdy m Amin, professor

Other trials in Egypt

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.

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 groups in NCT06857097
Study groupRoleWhat they receive
single anastomosis sleeve jejunal bypass groupActive comparatorNot described
Receives: Procedure: single anastomosis sleeve jejunal bypass
one anastomosis gastric bypassActive comparatordissection 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.

  1. 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.

  1. First posted4 Mar 2025
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

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)
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

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.

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