Morbid ObesityNCT06811623
Omentopexy After Sleeve Gastrectomy in Children and Adolescences.
A study testing Laparoscopic Sleeve Gastrectomy with omentopexy and Laparoscopic Sleeve Gastrectomy without omentopexy in people with Morbid Obesity and Pediatric Obesity, run by Mohammad Daboos.
Trial summary
Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric operation, has become one of the most commonly performed bariatric surgeries. Postoperative gastrointestinal complications are agonizing in patients underwent this procedure. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Morbid Obesity, Pediatric Obesity, LAP
- What is being tested?
- Laparoscopic Sleeve Gastrectomy with omentopexy and Laparoscopic Sleeve Gastrectomy without omentopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jan 2025
- 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- body mass index (BMI) of 40 kg/m2 or
- BMI of 35 kg/m2 due to at least 1 comorbid condition
Who cannot join
- secondary obesity
- more than 18 years
- previous operation
About this study
Official title: Omentopexy After Sleeve Gastrectomy in Children and Adolescences, is it Effective in Reducing Post-operative Complications.
Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric operation, has become one of the most commonly performed bariatric surgeries. Postoperative gastrointestinal complications are agonizing in patients underwent this procedure. Most of these complications can be prevented by omentopexy in association with sleeve gastrectomy. The Primary aim of this study to assess the effectiveness of omentopexy during laparoscopic sleeve gastrectomy in reducing post-operative complication.
Read the detailed description
This study was a carried out as a prospective study of 48 patients with obesity between January 2015 and October 2024. The patients were divided into 2 groups; group 1: included 24 patients managed with LSG with omentopexy and group 2: included 24 patients managed with LSG without omentopexy. Pre- operation data and post operation outcomes were taken for all patients in each group.
- Conditions
- Morbid Obesity, Pediatric Obesity, LAP
- Being tested
- Laparoscopic Sleeve Gastrectomy with omentopexy, Laparoscopic Sleeve Gastrectomy without omentopexy
- Medical subject headings
- Obesity, Morbid, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve Gastrectomy with omentopexyProcedure or surgery
Laparoscopic Sleeve Gastrectomy with omental fixation to the gastric tube
Laparoscopic Sleeve Gastrectomy without omentopexyProcedure or surgery
Laparoscopic Sleeve Gastrectomy without omental fixation to the gastric tube
| Study group | Role | What they receive |
|---|---|---|
| Group with Omentopexy | Active comparator | Laparoscopic Sleeve Gastrectomy with omentopexy Receives: Procedure: Laparoscopic Sleeve Gastrectomy with omentopexy |
| Group without Omentopexy | Active comparator | Laparoscopic Sleeve Gastrectomy without omentopexy Receives: Procedure: Laparoscopic Sleeve Gastrectomy without omentopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative complications
post operative nausea, vomiting and leakage
Measured: 6 months
Secondary outcomes (1)
operative time and hospital stay
the length of operative procedure and post-operative hospital stay
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Jan 2015
- Primary completion1 Oct 2024
- Study completion1 Jan 2025
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.
- 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
- Model description
- group 1: included 24 patients managed with Laparoscopic Sleeve Gastrectomy with omentopexy and group 2: included 24 patients managed with Laparoscopic Sleeve Gastrectomy without omentopexy.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammad Daboos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammad Daboos, Al-Azhar University
- Investigators
- Mohammad Daboos, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811623
- Sponsor's protocol ID
- 2/2015OBSGN63
- Status last verified
- Jan 2025
- First submitted
- 26 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omentopexy After Sleeve Gastrectomy in Children and Adolescences, is it Effective in Reducing Post-operative Complications.
- ClinicalTrials.gov ID
- NCT06811623
- Acronym / sponsor ID
- 2/2015OBSGN63
- Conditions
- Morbid Obesity, Pediatric Obesity, LAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mohammad DaboosUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 6 Feb 2025 (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.
Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric operation, has become one of the most commonly performed bariatric surgeries. Postoperative gastrointestinal complications are agonizing in patients underwent this procedure. Most of these complications can be prevented by omentopexy in association with sleeve gastrectomy. The Primary aim of this study to assess the effectiveness of omentopexy during laparoscopic sleeve gastrectomy in reducing post-operative complication.
Detailed description
This study was a carried out as a prospective study of 48 patients with obesity between January 2015 and October 2024. The patients were divided into 2 groups; group 1: included 24 patients managed with LSG with omentopexy and group 2: included 24 patients managed with LSG without omentopexy. Pre- operation data and post operation outcomes were taken for all patients in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- group 1: included 24 patients managed with Laparoscopic Sleeve Gastrectomy with omentopexy and group 2: included 24 patients managed with Laparoscopic Sleeve Gastrectomy without omentopexy.
| Arm | Type | Receives |
|---|---|---|
| Group with Omentopexy | Active comparator | Procedure: Laparoscopic Sleeve Gastrectomy with omentopexyLaparoscopic Sleeve Gastrectomy with omentopexy |
| Group without Omentopexy | Active comparator | Procedure: Laparoscopic Sleeve Gastrectomy without omentopexyLaparoscopic Sleeve Gastrectomy without omentopexy |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- body mass index (BMI) of 40 kg/m2 or
- BMI of 35 kg/m2 due to at least 1 comorbid condition
Key exclusion criteria (3 listed)
- secondary obesity
- more than 18 years
- previous operation
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 Sleeve Gastrectomy with omentopexyLaparoscopic Sleeve Gastrectomy with omental fixation to the gastric tube | Procedure or surgery | Group with Omentopexy |
| Laparoscopic Sleeve Gastrectomy without omentopexyLaparoscopic Sleeve Gastrectomy without omental fixation to the gastric tube | Procedure or surgery | Group without Omentopexy |
Primary outcome
post-operative complications
Time frame: 6 months
post operative nausea, vomiting and leakage
1 secondary outcome
operative time and hospital stay
Time frame: 6 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 6 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
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.
Mohammad Daboos principal investigator
Al-Azhar University
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Sleeve Gastrectomy with omentopexy and Laparoscopic Sleeve Gastrectomy without omentopexy in people with Morbid Obesity and Pediatric Obesity, run by Mohammad Daboos.
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 2 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
post-operative complications (time frame: 6 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 6 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.