Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants cannot take part if they:
What will happen in the study?
Participants will be assigned by chance to one of two groups:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: cyanoacrylate sealant (GlubranĀ®) | Experimental | Group A: the reinforcement of staple line was done by cyanoacrylate sealant (GlubranĀ®) from the angle of His till the lower end using its applicator through the right working port |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlubranĀ® 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From surgery up to 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 on the day of surgery. |
| Length of Hospital Stay After Sleeve Gastrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Intensity Assessment | This measure compares patient-reported pain levels (using a visual analog scale, VAS) (VAS, 0-10) during the first 7 days after surgery between the cyanoacrylate and omentum reinforcement groups. | Daily from day of surgery up to 7 days postoperatively. |
| Postoperative Nausea and Vomiting (PONV) Incidence |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Cairo University | Cairo | Al-Manial Cairo | 11956 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Autologous Greater Omentum | Biological | 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 Gastrectomy | Procedure | Reinforcement of the gastric staple line during laparoscopic 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. |
| 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 | 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. | 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. | 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. | Within 30 days postoperatively. |
This measure compares the incidence and severity of postoperative nausea and vomiting (PONV) in the first 48 hours after surgery between the two reinforcement groups. |
| From end of surgery up to 48 hours postoperatively. |
| Time to First Oral Intake | This measure compares the time (in hours) from end of surgery to first tolerated oral fluid intake (sips of water) between the two groups. | From end of surgery up to 48 hours. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D011183 | Postoperative Complications |
Not provided
Not provided