Obesity, MorbidNCT04823767
Single Anastomosis Sleeve Iejenal Bypass in Obese Patient With Hiatus Hernia
A study testing Single anastomosis sleeve jejunal bypass with hiatal repair in people with Obesity, Morbid, run by Minia University at 1 site in Egypt.
Trial summary
single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations 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?
- Single anastomosis sleeve jejunal bypass with hiatal repair
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2020to 15 Mar 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
Who cannot join
- patients refused to share in the study
- 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
- revisional bariatric procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Anastomosis Sleeve Iejenal Bypass With Crural Repair in Obese Patient With Hiatus Hernia
single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations
Read the detailed description
preoperative endoscopy was done and if hiatus hernia was present the patient is undergo single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations
- Conditions
- Obesity, Morbid
- Being tested
- Single anastomosis sleeve jejunal bypass with hiatal repair
- 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 bypass with hiatal repairOther
Single anastomosis sleeve jejunal bypass with hiatal repair
| Study group | Role | What they receive |
|---|---|---|
| Single anastomosis sleeve jejunal bypass with hiatal repair | Experimental | Single anastomosis sleeve jejunal bypass with hiatal repair Receives: Other: Single anastomosis sleeve jejunal bypass with hiatal repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of sleeve jejunal bypass on reflux manifestations
evaluation of the effect of sleeve jejunal bypass on reflux manifestations
Measured: 2 months
Secondary outcomes (2)
EWL
excess weight loss at one year
Measured: one year
treatment of comorbidities
effect on obesity comorbidities
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start12 Apr 2020
- Primary completion10 Mar 2021
- Study completion15 Mar 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
- 100 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
- NCT04823767
- Sponsor's protocol ID
- fac,med 20.3
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Anastomosis Sleeve Iejenal Bypass With Crural Repair in Obese Patient With Hiatus Hernia
- ClinicalTrials.gov ID
- NCT04823767
- Acronym / sponsor ID
- fac,med 20.3
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 12 Apr 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 1 Apr 2021 (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 with hiatal repair for morbid obesity with reflux manifestations
Detailed description
preoperative endoscopy was done and if hiatus hernia was present the patient is undergo single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations
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 bypass with hiatal repair | Experimental | Other: Single anastomosis sleeve jejunal bypass with hiatal repairSingle anastomosis sleeve jejunal bypass with hiatal repair |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 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
Key exclusion criteria (5 listed)
- patients refused to share in the study
- 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
- revisional bariatric procedures
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 bypass with hiatal repairSingle anastomosis sleeve jejunal bypass with hiatal repair | Other | Single anastomosis sleeve jejunal bypass with hiatal repair |
Primary outcome
the effect of sleeve jejunal bypass on reflux manifestations
Time frame: 2 months
evaluation of the effect of sleeve jejunal bypass on reflux manifestations
2 secondary outcomes
EWL
Time frame: one year
treatment of comorbidities
Time frame: one year
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 1 Apr 2021.
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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 Single anastomosis sleeve jejunal bypass with hiatal repair 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 3 inclusion and 5 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 1 Apr 2021. 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?
the effect of sleeve jejunal bypass on reflux manifestations (time frame: 2 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 1 Apr 2021.