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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
The mesh is intraperitoneal
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
Hôpital Jean Verdier, department of digestive and general surgery
Bondy, France
Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis
Time frame: 2 months
Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage
Time frame: 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
Time frame: 2 months
Postoperative fever > 38°5
Time frame: 2 months
Postoperative ileus
Time frame: 2 months
Postoperative phlebitis
Time frame: 2 months
Postoperative pulmonary embolism
Time frame: 2 months
Postoperative urinary infection
Time frame: 2 months
Duration of hospital stay
Time frame: 2 months
Duration of drainage
Time frame: 2 months
Mesh infection
Time frame: 24 months
Peritonitis due to intraperitoneal mesh
Time frame: 24 months
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Occlusion due to intra peritoneal mesh
Time frame: 2 months
Recurrence of incisional or umbilical hernia
Time frame: 24 months
Trocar site hernia
Time frame: 24 months