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Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter
Many techniques of ventral hernias repair have been reported. It is shown that open mesh hernia repairs have low recurrence and low complication rates then suture repair. But for hernias less than 3 cm some surgeons defend the treatment by suture. The main variable of interest is the location of mesh placement compared to suture repair. The investigator will compare in a prospective randomized clinical trial three techniques of abdominal wall hernia repair: preperitoneal polyester mesh, retromuscular polyester mesh and suture for hernias less than 3 cm. All patients underwent general anesthesia. The investigators used Polyester-based mesh because it has shown minimal shrinkage and excellent tissue ingrowth in animal models. Operative notes were physician-abstracted and the presence, type, and location of mesh prosthesis was recorded. Independent variables of interest were patient-level demographics (age and sex), facility where hernia repair occurred, year of hernia repair, preoperative comorbid conditions, history of prior repair, and intraoperative variables. The results compared postoperative pain was evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit, operating time evaluated as skin-to-skin time, drain management and both of early and late complications including seroma and hematoma formation, wound infection, fistula formation and recurrence rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preperitoneal mesh repair | Experimental | Ventral hernia repair using polyester preperitoneal mesh repair |
|
| Retromuscular mesh repair | Experimental | Ventral hernia repair using polyester retromuscular mesh repair |
|
| Suture repair | Experimental | Ventral hernia repair using suture repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventral hernia repair | Procedure | Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rates | Late complications of ventral hernia repair | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time | operating time evaluated as skin-to-skin time | 15 to 90 minutes |
| Early complication | Early complicaion including seroma and hematoma formation, wound infection and fistula |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moez Boudokhane, MD | Contact | 98461511 | +216 | Moez-chir@yahoo.fr |
| Mohamed Ali Chaouch, RD | Contact | 26205105 | +216 | Docmedalichaouch@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taher Sfar Hospital | Recruiting | Mahdia | 5100 | Tunisia |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D006554 | Hernia, Umbilical |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 30 days |
| Postoperative pain | Postoperative pain evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit | 6, 12 and 24 hours |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |