Morbid ObesityNCT02870530
Single Anastomosis Sleeve Jejunal (SAS-J) Bypass
A study testing Single Anastomosis Sleeve Jejunal (SAS-J) Bypass in people with Morbid Obesity, run by Minia University at 1 site in Egypt.
Trial summary
The purpose of this study is to determine the efficacy of single anastomoses sleeve jejunal bypass as a treatment for morbid obesity Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Single Anastomosis Sleeve Jejunal (SAS-J) Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Apr 2017
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- obese patients with BMI more than 40
- patients fit for laparoscopic surgery
- give approval to share in the study
Who cannot join
- patients refused to share in the study
- patients unfit for surgery
- patients aged less than 18 and older than 50
- patients with BMI less than 50
- patient with previous upper abdominal surgery either for obesity or other diseases
- patients with preoperative GERD clinically or by investigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A Treatment for Morbid Obesity
The purpose of this study is to determine the efficacy of single anastomoses sleeve jejunal bypass as a treatment for morbid obesity
Read the detailed description
in this study the investigators aim to test a new technique ( single anastomoses sleeve jejunal as a treatment for morbid obesity Which is a modification of Single anastomoses sleeve ileal bypass with short biliary limb ( about one third of the small intestine from the Duodeno-jejunal junction
- Conditions
- Morbid Obesity
- Being tested
- Single Anastomosis Sleeve Jejunal (SAS-J) Bypass
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Anastomosis Sleeve Jejunal (SAS-J) BypassProcedure or surgery
Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A treatment for Morbid
| Study group | Role | What they receive |
|---|---|---|
| Single Anastomosis Sleeve Jejunal (SAS-J) Bypass | Experimental | Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A treatment for Morbid Receives: Procedure: Single Anastomosis Sleeve Jejunal (SAS-J) Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
the operative time from skin incision to skin closure
Measured: the 1st 24 hours
intraoperative complications
intraoperative complications like bleeding, other organs injuries
Measured: the 1st 24 hours
the postoperative weight loss
the percentage of weight loss from total excess body weight
Measured: 12 month
Secondary outcomes (1)
effect on metabolic syndrome if present
effect on blood sugar level, blood pressure and blood cholesterol level
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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
- 200 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
- Investigators
- Alaa M Sewefy, MD, Study chair, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870530
- Sponsor's protocol ID
- fac.med.016
- Status last verified
- Feb 2022
- First submitted
- 10 Aug 2016
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A Treatment for Morbid Obesity
- ClinicalTrials.gov ID
- NCT02870530
- Acronym / sponsor ID
- fac.med.016
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 17 Aug 2016 (estimated)
- 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 purpose of this study is to determine the efficacy of single anastomoses sleeve jejunal bypass as a treatment for morbid obesity
Detailed description
in this study the investigators aim to test a new technique ( single anastomoses sleeve jejunal as a treatment for morbid obesity Which is a modification of Single anastomoses sleeve ileal bypass with short biliary limb ( about one third of the small intestine from the Duodeno-jejunal junction
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Anastomosis Sleeve Jejunal (SAS-J) Bypass | Experimental | Procedure: Single Anastomosis Sleeve Jejunal (SAS-J) BypassSingle Anastomosis Sleeve Jejunal (SAS-J) Bypass as A treatment for Morbid |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- obese patients with BMI more than 40
- patients fit for laparoscopic surgery
- give approval to share in the study
Key exclusion criteria (6 listed)
- patients refused to share in the study
- patients unfit for surgery
- patients aged less than 18 and older than 50
- patients with BMI less than 50
- 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 |
|---|---|---|
| Single Anastomosis Sleeve Jejunal (SAS-J) BypassSingle Anastomosis Sleeve Jejunal (SAS-J) Bypass as A treatment for Morbid | Procedure or surgery | Single Anastomosis Sleeve Jejunal (SAS-J) Bypass |
Primary outcome
operative time
Time frame: the 1st 24 hours
the operative time from skin incision to skin closure
intraoperative complications
Time frame: the 1st 24 hours
intraoperative complications like bleeding, other organs injuries
the postoperative weight loss
Time frame: 12 month
the percentage of weight loss from total excess body weight
1 secondary outcome
effect on metabolic syndrome if present
Time frame: 12 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 11 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.
Alaa M Sewefy, MD study chair
Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.
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 (SAS-J) Bypass in people with Morbid Obesity, 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 3 inclusion and 6 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 11 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?
operative time (time frame: the 1st 24 hours). The study lists 3 primary outcomes in all. 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 2022.