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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-A00374-49 | Other Identifier | IDRCB |
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lack of recrutment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic approach | Experimental | group A: Laparoscopic approach |
|
| Open approach | Active Comparator | group B: Open anterior approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic mesh hernia repair | Procedure | The mesh is intraperitoneal |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Postoperative fever > 38°5 | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinne Ms Vons, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Jean Verdier, department of digestive and general surgery | Bondy | 93140 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18645551 | Background | Slim K, Vons C. [Inguinal hernia repair: results of randomized clinical trials and meta-analyses]. J Chir (Paris). 2008 Mar-Apr;145(2):122-5. doi: 10.1016/s0021-7697(08)73720-7. French. | |
| 15738845 | Background | Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):366-70. doi: 10.1016/s0021-7697(04)95361-6. No abstract available. French. |
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| D006554 | Hernia, Umbilical |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| Open anterior approach | Procedure | 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 |
|
|
| Postoperative ileus | 2 months |
| Postoperative phlebitis | 2 months |
| Postoperative pulmonary embolism | 2 months |
| Postoperative urinary infection | 2 months |
| Duration of hospital stay | 2 months |
| Duration of drainage | 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 |
| 15738844 | Background | Proske JM, Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):360-4. doi: 10.1016/s0021-7697(04)95360-4. French. |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006555 | Hernia, Ventral |
| D046449 | Hernia, Abdominal |