Incisional Hernia, Umbilical Hernia
Conditions
Keywords
Laparoscopy, Incisional hernia, Umbilical hernia, Mesh repair, Postoperative complications
Brief summary
The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.
Detailed description
The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia. Five hundred patients will be included in this randomized, multicentric trial. Hypotheses are that laparoscopic approach: 1- reduces immediate parietal complications without increasing intra abdominal septic complications 2- is less invasive and also reduces patients' hospital stay and recovery time; 3- has the same efficacy, than open approach.
Interventions
PROCEDURELaparoscopic mesh hernia repair
The mesh is intraperitoneal
PROCEDUREOpen anterior approach
The mesh is placed by an anterior approach. It is placed after incision of the skin over or under the abdominal muscles, or is intraperitoneal
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 * Incisional or umbilical hernia over 2 cm and less than 6 cm in diameter
Exclusion criteria
* Patients with a complicated incisional (pain, occlusion, cutaneous necrosis), irreductible painless incisional or umbilical hernia will not be considered as a complication * Patients with a recurrence of incisional hernia * Patients with an incisional or umbilical hernia whose lateral edges are located so that fixation of the mesh (which must extend beyond the 4 to 5 cm) is not possible * Pregnant women * Patients with HIV therapy * Patients with cirrhotic ascites or other signs of hepatic insufficiency (bilirubin\> 35 micromol / l; TP \< 55%) or significant thrombocytopenia (\< 60 000 platelets) * Patients with a contra indication for laparoscopy * Patients with a life expectancy \< one year, or whose mobility within two years of treatment will damage proper monitoring * Patients unable to understand information about the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis | 2 months |
| Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative ileus | 2 months |
| Postoperative phlebitis | 2 months |
| Postoperative pulmonary embolism | 2 months |
| Postoperative urinary infection | 2 months |
| Duration of hospital stay | 2 months |
| Postoperative pain: measured by a- Visual Analogic Score (VAS 0-10): 1-number of days with VAS > 5; 2- maximal VAS, and b- duration (days) of morphine use | 2 months |
| Mesh infection | 24 months |
| Peritonitis due to intraperitoneal mesh | 24 months |
| Occlusion due to intra peritoneal mesh | 2 months |
| Recurrence of incisional or umbilical hernia | 24 months |
| Trocar site hernia | 24 months |
| Duration of drainage | 2 months |
| Postoperative fever > 38°5 | 2 months |
Countries
France
Outcome results
None listed