Obesity, MorbidNCT04144361
Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication
A study testing sleeve with plication and sleeve without plication in people with Obesity, Morbid, run by Minia University at 2 sites in Egypt.
Trial summary
three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. 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?
- sleeve with plication and sleeve without plication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesEgypt
- Study dates
- 27 Dec 2019to 20 Aug 2020
- 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
2 sites in 1 country.
Egypt2 sites
Faculty of medicine
Minya, 61511
Minya university hospital
Minya, 61511
About this study
Official title: Outcomes of Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication
three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the aim is to test the effect of pilcation on the incidence of leaks and bleeding
Read the detailed description
three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the primary outcomes is the incidence of leaks and bleeding which is the main nightmare of sleeve gastrectomy, secondary outcome operative time, weight loss and metabolic effect
- Conditions
- Obesity, Morbid
- Being tested
- sleeve with plication, sleeve without plication
- Keywords
- post sleeve gastrectomy leak, post sleeve gastrectomy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve with plicationProcedure or surgery
sleeve with plication
sleeve without plicationProcedure or surgery
sleeve without plication
| Study group | Role | What they receive |
|---|---|---|
| sleeve without plication | Experimental | sleeve gastrectomy on bougie 36 without plication Receives: Procedure: sleeve without plication |
| sleeve with plication | Active comparator | sleeve gastrectomy on bougie 42 without plication Receives: Procedure: sleeve with plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of postoperative stable line bleeding
early postoperative bleeding from stable line
Measured: 2-24 hours
the incidence of stable line leakage
leak from stable line
Measured: 1-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start27 Dec 2019
- Primary completion20 Aug 2020
- Study completion20 Aug 2020
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 400 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, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144361
- Sponsor's protocol ID
- fac,med 19.32
- Status last verified
- Mar 2021
- First submitted
- 20 Oct 2019
- Last updated
- 30 Mar 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 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication
- ClinicalTrials.gov ID
- NCT04144361
- Acronym / sponsor ID
- fac,med 19.32
- Conditions
- Obesity, Morbid
- Keywords
- post sleeve gastrectomy leak, post sleeve gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 30 Oct 2019 (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.
three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the aim is to test the effect of pilcation on the incidence of leaks and bleeding
Detailed description
three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the primary outcomes is the incidence of leaks and bleeding which is the main nightmare of sleeve gastrectomy, secondary outcome operative time, weight loss and metabolic effect
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sleeve without plication | Experimental | Procedure: sleeve without plicationsleeve gastrectomy on bougie 36 without plication |
| sleeve with plication | Active comparator | Procedure: sleeve with plicationsleeve gastrectomy on bougie 42 without plication |
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 |
|---|---|---|
| sleeve with plicationsleeve with plication | Procedure or surgery | sleeve with plication |
| sleeve without plicationsleeve without plication | Procedure or surgery | sleeve without plication |
Primary outcome
the incidence of postoperative stable line bleeding
Time frame: 2-24 hours
early postoperative bleeding from stable line
the incidence of stable line leakage
Time frame: 1-30 days
leak from stable line
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 30 Mar 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.
alaa M Sewefy principal investigator
Minia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleeve with plication and sleeve without plication in people with Obesity, Morbid, run by Minia University at 2 sites 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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 incidence of postoperative stable line bleeding (time frame: 2-24 hours). The study lists 2 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 30 Mar 2021.