Umbilical Hernia, Ventral Hernia, Ventral Incisional Hernia
Conditions
Keywords
ventral hernia, Open mesh repair, Polyester mesh, Preperitoneal, Retromuscular
Brief summary
Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter
Detailed description
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.
Interventions
PROCEDUREVentral hernia repair
Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.
Sponsors
Hôpital Universitaire Taher Sfar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rates | One year | Late complications of ventral hernia repair |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating time | 15 to 90 minutes | operating time evaluated as skin-to-skin time |
| Early complication | 30 days | Early complicaion including seroma and hematoma formation, wound infection and fistula |
| Postoperative pain | 6, 12 and 24 hours | Postoperative pain evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit |
Countries
Tunisia
Contacts
Primary ContactMoez Boudokhane, MD
Backup ContactMohamed Ali Chaouch, RD
Outcome results
None listed