ObesityNCT07339020
Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy
A study testing Glubran® 2 surgical glue (n-butyl-2-cyanoacrylate mixture) and its specific applicator., Autologous Greater Omentum and Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy in people with Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
Study Title: Comparing Surgical Glue (Cyanoacrylate) vs. Omentum Tissue to Strengthen Staple Lines in Weight-Loss Sleeve Surgery What is the purpose of this study? This study will compare two ways to strengthen the staple line during weight-loss sleeve surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Glubran® 2 surgical glue (n-butyl-2-cyanoacrylate mixture) and its specific applicator., Autologous Greater Omentum and Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2025to 14 May 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases underwent LSG with age ≥18 years old and ≤65 years old and BMI ≥35 or ≥30 with comorbid disease related to obesity.
- Candidate for Laparoscopic Sleeve Gastrectomy
Who cannot join
- Cases underwent previous bariatric surgery.
- Multiple Extensive previous surgeries.
- Crohn's Disease.
- Elderly patients with extensive comorbidities
- Severe gastroesophageal reflux disease (GERD)
- Severe Bleeding disorders
- Psychiatric illness or cognitive impairment affecting consent or compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cyanoacrylate Versus Omentum for Enforcement of the Staple Line in Sleeve Operation
Study Title:
Comparing Surgical Glue (Cyanoacrylate) vs. Omentum Tissue to Strengthen Staple Lines in Weight-Loss Sleeve Surgery
Read more
What is the purpose of this study? This study will compare two ways to strengthen the staple line during weight-loss sleeve surgery. One way uses a medical glue called cyanoacrylate, and the other uses a piece of tissue from the abdomen called omentum. The goal is to see which method works better to lower the chance of bleeding, pain, or leaks after surgery.
Who can take part?
Adults ages 18-65 who:
- Have a body mass index (BMI) over 35, or over 30 if they also have health problems related to obesity.
- Are scheduled to have weight-loss sleeve surgery at Cairo University Hospital.
Participants cannot take part if they:
- Are younger than 18 or older than 65.
- Have had weight-loss surgery before.
What will happen in the study?
- Participants will be assigned by chance to one of two groups:
- Glue group: The staple line will be sealed with medical glue.
- Omentum group:The staple line will be covered and sewn with a piece of the body's own tissue.
- Everyone will have the same type of surgery and be cared for in the same way afterward.
- Participants will be monitored closely for one month after surgery to check for problems like bleeding, pain, or leaks.
- Follow-up visits will happen within one week after surgery and again at one month.
What are the possible risks? The risks are low and similar to those of regular weight-loss surgery. Some people may feel pain or anxiety after surgery. The study team will watch for any problems and treat them right away.
Why is this study being done? Weight-loss sleeve surgery is common, but sometimes the staple line can leak or bleed. Finding a better way to strengthen it may help people recover more safely and with less pain.
How long will the study last? The study will take about six months to complete, including surgery and follow-up.
Who is running the study? The study is being done by doctors in the General Surgery Department at Cairo University's Faculty of Medicine.
- Conditions
- Obesity
- Being tested
- Glubran® 2 surgical glue (n-butyl-2-cyanoacrylate mixture) and its specific applicator., Autologous Greater Omentum, Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy
- Keywords
- Bariatric surgery, Cyanoacrylate, Glubran, Laparoscopic sleeve gastrectomy, Omentopexy, Staple Line Reinforcement, Postoperative Hemorrhage, Surgical Leak
- Medical subject headings
- Obesity, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glubran® 2 surgical glue (n-butyl-2-cyanoacrylate mixture) and its specific applicator.Device
A synthetic surgical adhesive applied to the staple line for reinforcement and hemostasis using its proprietary delivery applicator.
Autologous Greater OmentumBiological
pedicled flap of the patient's own greater omentum sutured over the staple line for reinforcement using a PDS 2/0 round needle suture.
Staple Line Reinforcement during Laparoscopic Sleeve GastrectomyProcedure or surgery
Reinforcement of the gastric staple line during laparoscopic sleeve gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Group A: cyanoacrylate sealant (Glubran®) | Experimental | Group A: the reinforcement of staple line was done by cyanoacrylate sealant (Glubran®) from the angle of His till the lower end using its applicator through the right working port Receives: Device: Glubran® 2 surgical glue (n-butyl-2-cyanoacrylate mixture) and its specific applicator.; Procedure: Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy |
| Group B: Omentopexy | Active comparator | Group B: the reinforcement was done by suturing the greater omentum to the staple line using PDS 2/0 round. Receives: Biological: Autologous Greater Omentum; Procedure: Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Staple Line Complications After Sleeve Gastrectomy: Glubran vs. Omentum
This measure compares two methods of staple line reinforcement during laparoscopic sleeve gastrectomy to see which works better at preventing complications within the first 30 days after surgery. The complications of interest are postoperative leakage (staple line leak), bleeding requiring intervention, and abdominal pain. Patients are randomly assigned to have their staple line reinforced either with medical glue (cyanoacrylate) or with the patient's own fatty tissue (omentum).
Measured: From surgery up to 30 days postoperatively
Secondary outcomes (6)
Comparison of Operative Time Between Reinforcement Methods
This measure compares the total surgical time (in hours) from skin incision to closure between the two study groups: cyanoacrylate glue reinforcement vs. omentum reinforcement.
Measured: Measured on the day of surgery.
Length of Hospital Stay After Sleeve Gastrectomy
This measure compares the number of days patients stay in the hospital after surgery between the two reinforcement groups, from the day of surgery until discharge.
Measured: From surgery until discharge, assessed up to 30 days postoperatively.
Economic Cost of Reinforcement Materials
This measure compares the direct cost of the reinforcement materials used in each group: cyanoacrylate glue versus omentum
Measured: Assessed on the day of surgery
Incidence of Delayed Staple Line Complications
This measure assesses whether any staple line complications (such as delayed leakage or bleeding) occur after discharge, within the first month post-surgery.
Measured: From discharge up to 30 days postoperatively.
Rate of Hospital Readmission Within 30 Days
This measure compares the proportion of patients in each group who are readmitted to the hospital within 30 days after discharge due to any surgery-related complication.
Measured: Within 30 days after discharge.
Rate of Reoperation Within 30 Days
This measure compares the proportion of patients in each group who require a second surgical intervention (reoperation) within 30 days after the initial surgery due to complications such as bleeding, leakage, or hematoma.
Measured: Within 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start20 Jun 2025
- Primary completion6 May 2026
- Study completion14 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Eid Ali Ahmed Aziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339020
- Sponsor's protocol ID
- ms-199-2025
- Status last verified
- May 2026
- First submitted
- 24 Dec 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyanoacrylate Versus Omentum for Enforcement of the Staple Line in Sleeve Operation
- ClinicalTrials.gov ID
- NCT07339020
- Acronym / sponsor ID
- ms-199-2025
- Conditions
- Obesity
- Keywords
- Bariatric surgery, Cyanoacrylate, Glubran, Laparoscopic sleeve gastrectomy, Omentopexy, Staple Line Reinforcement, Postoperative Hemorrhage, Surgical Leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 14 Jan 2026 (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.
Study Title:
Comparing Surgical Glue (Cyanoacrylate) vs. Omentum Tissue to Strengthen Staple Lines in Weight-Loss Sleeve Surgery
What is the purpose of this study? This study will compare two ways to strengthen the staple line during weight-loss sleeve surgery. One way uses a medical glue called cyanoacrylate, and the other uses a piece of tissue from the abdomen called omentum. The goal is to see which method works better to lower the chance of bleeding, pain, or leaks after surgery.
Who can take part?
Adults ages 18-65 who:
- Have a body mass index (BMI) over 35, or over 30 if they also have health problems related to obesity.
- Are scheduled to have weight-loss sleeve surgery at Cairo University Hospital.
Participants cannot take part if they:
- Are younger than 18 or older than 65.
- Have had weight-loss surgery before.
What will happen in the study?
- Participants will be assigned by chance to one of two groups:
- Glue group: The staple line will be sealed with medical glue.
- Omentum group:The staple line will be covered and sewn with a piece of the body's own tissue.
- Everyone will have the same type of surgery and be cared for in the same way afterward.
- Participants will be monitored closely for one month after surgery to check for problems like bleeding, pain, or leaks.
- Follow-up visits will happen within one week after surgery and again at one month.
What are the possible risks? The risks are low and similar to those of regular weight-loss surgery. Some people may feel pain or anxiety after surgery. The study team will watch for any problems and treat them right away.
Why is this study being done? Weight-loss sleeve surgery is common, but sometimes the staple line can leak or bleed. Finding a better way to strengthen it may help people recover more safely and with less pain.
How long will the study last? The study will take about six months to complete, including surgery and follow-up.
Who is running the study? The study is being done by doctors in the General Surgery Department at Cairo University's Faculty of Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: cyanoacrylate sealant (Glubran®) | Experimental | Device: Glubran® 2 surgical glue (n-butyl-2-cyanoacrylate mixture) and its specific applicator., Procedure: Staple Line Reinforcement during Laparoscopic Sleeve GastrectomyGroup A: the reinforcement of staple line was done by cyanoacrylate sealant (Glubran®) from the angle of His till the lower end using its applicator through the right working port |
| Group B: Omentopexy | Active comparator | Biological: Autologous Greater Omentum, Procedure: Staple Line Reinforcement during Laparoscopic Sleeve GastrectomyGroup B: the reinforcement was done by suturing the greater omentum to the staple line using PDS 2/0 round. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cases underwent LSG with age ≥18 years old and ≤65 years old and BMI ≥35 or ≥30 with comorbid disease related to obesity.
- Candidate for Laparoscopic Sleeve Gastrectomy
Key exclusion criteria (7 listed)
- Cases underwent previous bariatric surgery.
- Multiple Extensive previous surgeries.
- Crohn's Disease.
- Elderly patients with extensive comorbidities
- Severe gastroesophageal reflux disease (GERD)
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 |
|---|---|---|
| Glubran® 2 surgical glue (n-butyl-2-cyanoacrylate mixture) and its specific applicator.A synthetic surgical adhesive applied to the staple line for reinforcement and hemostasis using its proprietary delivery applicator. | Device | Group A: cyanoacrylate sealant (Glubran®) |
| Autologous Greater Omentumpedicled flap of the patient's own greater omentum sutured over the staple line for reinforcement using a PDS 2/0 round needle suture. | Biological | Group B: Omentopexy |
| Staple Line Reinforcement during Laparoscopic Sleeve GastrectomyReinforcement of the gastric staple line during laparoscopic sleeve gastrectomy. | Procedure or surgery | Group A: cyanoacrylate sealant (Glubran®), Group B: Omentopexy |
Primary outcome
Comparison of Staple Line Complications After Sleeve Gastrectomy: Glubran vs. Omentum
Time frame: From surgery up to 30 days postoperatively
This measure compares two methods of staple line reinforcement during laparoscopic sleeve gastrectomy to see which works better at preventing complications within the first 30 days after surgery. The complications of interest are postoperative leakage (staple line leak), bleeding requiring intervention, and abdominal pain. Patients are randomly assigned to have their staple line reinforced either with medical glue (cyanoacrylate) or with the patient's own fatty tissue (omentum).
6 secondary outcomes
Comparison of Operative Time Between Reinforcement Methods
Time frame: Measured on the day of surgery.
Length of Hospital Stay After Sleeve Gastrectomy
Time frame: From surgery until discharge, assessed up to 30 days postoperatively.
Economic Cost of Reinforcement Materials
Time frame: Assessed on the day of surgery
Incidence of Delayed Staple Line Complications
Time frame: From discharge up to 30 days postoperatively.
Rate of Hospital Readmission Within 30 Days
Time frame: Within 30 days after discharge.
Rate of Reoperation Within 30 Days
Time frame: Within 30 days postoperatively.
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 18 May 2026.
- Individual participant dataSharing planned: No
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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 Glubran® 2 surgical glue (n-butyl-2-cyanoacrylate mixture) and its specific applicator., Autologous Greater Omentum and Staple Line Reinforcement during Laparoscopic Sleeve Gastrectomy in people with Obesity, run by Cairo 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 2 inclusion and 7 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 18 May 2026. 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?
Comparison of Staple Line Complications After Sleeve Gastrectomy: Glubran vs. Omentum (time frame: From surgery up to 30 days postoperatively). 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 18 May 2026.