Randomized Clinical Trial Comparing Open Preperitoneal Mesh, Retromuscular Mesh and Suture Repair for Abdominal Wall Hernias Less Than 3 cm Diameter
| Registry | NCT03255239 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 120 (Estimated) |
| Sponsor | Hôpital Universitaire Taher Sfar (Other gov) |
| Conditions | Ventral Hernia, Ventral Incisional Hernia, Umbilical Hernia |
| Interventions | Ventral hernia repair (Procedure) |
| Dates | start 2017-08-01, primary completion 2017-08-01, completion 2019-12-31 (estimated), first posted 2017-08-21, last updated 2017-08-23 |
| Locations | 1 site in Tunisia |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Preperitoneal mesh repair | Experimental | Procedure: Ventral hernia repair | Ventral hernia repair using polyester preperitoneal mesh repair |
| Retromuscular mesh repair | Experimental | Procedure: Ventral hernia repair | Ventral hernia repair using polyester retromuscular mesh repair |
| Suture repair | Experimental | Procedure: Ventral hernia repair | Ventral hernia repair using suture repair |
Sex: All, ages: 18 Years to 90 Years, accepts healthy volunteers
Inclusion Criteria: * Vebtral hernia or post incisional hernia diameter < 3 cm * Male or female aged between 18 and 90 year-old * Elective surgery for ventral hernia Exclusion Criteria: * Any contraindication to the prosthetic treatment. * Any hernia or incisional hernia with a collar strictly greater than 3 cm. * Previous hernia mesh repaired * contraindication for general anaesthesia * Pregnancy
| Facility | City | Country | Status |
|---|---|---|---|
| Taher Sfar Hospital | Mahdia | Tunisia | Recruiting |