Obesity, MorbidNCT05269420
Single Anastomosis Sleeve Jejunal Bypass as a Revisional Bariatric Procedure
A study testing SAS-J in people with Obesity, Morbid, run by Minia University at 1 site in Egypt.
Trial summary
single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- SAS-J
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2017to 4 Jan 2021
- Phase
- Interventional
- 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
Who may be able to join
- obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
- patients fit for laparoscopic surgery
- give approval to share in the study
- previous restrictive bariatric procedure
Who cannot join
- patients unfit for surgery
- patients aged less than 18 and older than 60
- patient with previous upper abdominal surgery either for obesity or other diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Anastomosis Sleeve Jejunal Bypass as a Revisional Operation After Restrictive Bariatric Proceures
single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band
Read the detailed description
in this study the investigators aim to test the efficacy of single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band
- Conditions
- Obesity, Morbid
- Being tested
- SAS-J
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAS-JProcedure or surgery
Single Anastomosis Sleeve Jejunal Bypass
| Study group | Role | What they receive |
|---|---|---|
| SAS-J | Experimental | single anastomosis sleeve Jejunal Bypass as a revisional bariatric procedure after restrictive bariatric procedures Receives: Procedure: SAS-J |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
percentage of excess weight loss in kilogram
Measured: 12 months
Secondary outcomes (3)
the rate of improved co morbidity
the effect of the operation on co morbidity like diabetes and hypertension
the effect of the operation on co morbidity like diabetes and hypertension the effect of single anastomosis sleeve jejunal bypass of comorbidities
Measured: 12 months
the incidence of nutritional deficiency
the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.
the incidence of nutritional deficiency like ca, iron, vitaminD and protein malnutrition
Measured: 12-24 months
the incidence of early operative complications the incidence of early operative complications the incidence of early operative complications the incidence of complications
early operative complications like leak, bleeding
complications like leak, bleeding, dumping,
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start12 Jan 2017
- Primary completion8 Dec 2020
- Study completion4 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Minia 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mstafa Hassan Sewefy, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269420
- Sponsor's protocol ID
- ac.med.21.23
- Status last verified
- Feb 2022
- First submitted
- 25 Feb 2022
- Last updated
- 8 Mar 2022
- 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 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Anastomosis Sleeve Jejunal Bypass as a Revisional Operation After Restrictive Bariatric Proceures
- ClinicalTrials.gov ID
- NCT05269420
- Acronym / sponsor ID
- ac.med.21.23
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 4 Jan 2021 (actual)
- First posted
- 8 Mar 2022 (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.
single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band
Detailed description
in this study the investigators aim to test the efficacy of single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAS-J | Experimental | Procedure: SAS-Jsingle anastomosis sleeve Jejunal Bypass as a revisional bariatric procedure after restrictive bariatric procedures |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
- patients fit for laparoscopic surgery
- give approval to share in the study
- previous restrictive bariatric procedure
Key exclusion criteria (3 listed)
- patients unfit for surgery
- patients aged less than 18 and older than 60
- patient with previous upper abdominal surgery either for obesity or other diseases
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 |
|---|---|---|
| SAS-JSingle Anastomosis Sleeve Jejunal Bypass | Procedure or surgery | SAS-J |
Primary outcome
weight loss
Time frame: 12 months
percentage of excess weight loss in kilogram
3 secondary outcomes
the rate of improved co morbidity
Time frame: 12 months
the incidence of nutritional deficiency
Time frame: 12-24 months
the incidence of early operative complications the incidence of early operative complications the incidence of early operative complications the incidence of complications
Time frame: 12-24 months
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 8 Mar 2022.
- 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?
A study testing SAS-J in people with Obesity, Morbid, run by Minia 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 4 inclusion and 3 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 8 Mar 2022. 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: 12 months). 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 8 Mar 2022.