Morbid ObesityLIGBNCT02878525
Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure
A study testing Laparoscopic internal gastric banding and laparoscopic sleeve gastrectomy in people with Morbid Obesity, run by Minia University at 2 sites in Egypt.
Trial summary
The purpose of this study is to study the effectiveness of laparoscopic internal gastric banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy 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?
- Laparoscopic internal gastric banding and laparoscopic sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesEgypt
- Study dates
- Oct 2016to Dec 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
- BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
- Approval to share in the study
- Patients fit for laparoscopic surgery
Who cannot join
- Patient age less than 18 or more than 50 years old
- Refusal to share in the study
- Unfit for surgery
- patients with gastroesophageal reflux disease clinically or by investigation
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of medicine
Minya, 61511
Minia university hospital
Minya, 61511
About this study
Official title: Study the Effectiveness and Safety of Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure, in Comparison to Laparoscopic Sleeve Gastrectomy
The purpose of this study is to study the effectiveness of laparoscopic internal gastric banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy
Read the detailed description
In this study 190 morbidly obese patients will be included and will randomly assign into 2 groups, group 1 will be operated by laparoscopic internal gastric banding and group 2 by laparoscopic sleeve gastrectomy, the patients will be followed up for 1 year to evaluate the effectiveness and drawbacks of laparoscopic internal gastric banding in comparison to laparoscopic sleeve gastrectomy, the investigators preparing to submit our study protocol to our institution ethical committee for approval to start the study
- Conditions
- Morbid Obesity
- Being tested
- Laparoscopic internal gastric banding, laparoscopic 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.
Laparoscopic internal gastric bandingProcedure or surgery
Laparoscopic internal gastric banding
laparoscopic sleeve gastrectomyProcedure or surgery
laparoscopic sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic internal gastric banding | Experimental | Laparoscopic internal gastric banding Receives: Procedure: Laparoscopic internal gastric banding |
| Laparoscopic sleeve gastrectomy | Active comparator | Laparoscopic sleeve gastrectomy Receives: Procedure: laparoscopic sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of the technique
the incidence of introperative and early postoperative complications
Measured: 4 weeks
Secondary outcomes (4)
operative time
the operative time from skin to skin
Measured: 12 hours
Hospital stay
Time of hospital stay
Measured: 30 days
total cost
the total cost of the technique by US dollar and its early complications
Measured: 16 weeks
Metabolic effect
Effect of the procedure on blood sugar, serum lipid and hypertension
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017
- Study completionDec 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 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
- NCT02878525
- Sponsor's protocol ID
- fac.med.018
- Acronym
- LIGB
- Status last verified
- Jan 2018
- First submitted
- 21 Aug 2016
- Last updated
- 5 Feb 2018
- 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 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Effectiveness and Safety of Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure, in Comparison to Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02878525
- Acronym / sponsor ID
- LIGB / fac.med.018
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 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 study the effectiveness of laparoscopic internal gastric banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy
Detailed description
In this study 190 morbidly obese patients will be included and will randomly assign into 2 groups, group 1 will be operated by laparoscopic internal gastric banding and group 2 by laparoscopic sleeve gastrectomy, the patients will be followed up for 1 year to evaluate the effectiveness and drawbacks of laparoscopic internal gastric banding in comparison to laparoscopic sleeve gastrectomy, the investigators preparing to submit our study protocol to our institution ethical committee for approval to start the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic internal gastric banding | Experimental | Procedure: Laparoscopic internal gastric bandingLaparoscopic internal gastric banding |
| Laparoscopic sleeve gastrectomy | Active comparator | Procedure: laparoscopic sleeve gastrectomyLaparoscopic sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
- Approval to share in the study
- Patients fit for laparoscopic surgery
Key exclusion criteria (4 listed)
- Patient age less than 18 or more than 50 years old
- Refusal to share in the study
- Unfit for surgery
- patients with gastroesophageal reflux disease clinically or by investigation
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 |
|---|---|---|
| Laparoscopic internal gastric bandingLaparoscopic internal gastric banding | Procedure or surgery | Laparoscopic internal gastric banding |
| laparoscopic sleeve gastrectomylaparoscopic sleeve gastrectomy | Procedure or surgery | Laparoscopic sleeve gastrectomy |
Primary outcome
safety of the technique
Time frame: 4 weeks
the incidence of introperative and early postoperative complications
4 secondary outcomes
operative time
Time frame: 12 hours
Hospital stay
Time frame: 30 days
total cost
Time frame: 16 weeks
Metabolic effect
Time frame: 6-12 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 5 Feb 2018.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic internal gastric banding and laparoscopic sleeve gastrectomy in people with Morbid Obesity, 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 4 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 5 Feb 2018. 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?
safety of the technique (time frame: 4 weeks). 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 5 Feb 2018; AzTrials last refreshed its copy on 7 Nov 2026.