Clinical trial NCT00970515: Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia
Official title: A Prospective, Multicenter, Randomized Trial Comparing Laparoscopy VS Conventional Mesh Repair of Incisional and Umbilical Hernia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Incisional Hernia
Umbilical Hernia
Keywords: Laparoscopy
Incisional hernia
Umbilical hernia
Mesh repair
Postoperative complications
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis
timeFrame: 2 months
measure: Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage
timeFrame: 2 months
Secondary outcomes:
measure: 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
timeFrame: 2 months
measure: Postoperative fever > 38°5
timeFrame: 2 months
measure: Postoperative ileus
timeFrame: 2 months
measure: Postoperative phlebitis
timeFrame: 2 months
measure: Postoperative pulmonary embolism
timeFrame: 2 months
measure: Postoperative urinary infection
timeFrame: 2 months
measure: Duration of hospital stay
timeFrame: 2 months
measure: Duration of drainage
timeFrame: 2 months
measure: Mesh infection
timeFrame: 24 months
measure: Peritonitis due to intraperitoneal mesh
timeFrame: 24 months
measure: Occlusion due to intra peritoneal mesh
timeFrame: 2 months
measure: Recurrence of incisional or umbilical hernia
timeFrame: 24 months
measure: Trocar site hernia
timeFrame: 24 months
Other outcomes:
Locations:
city: Bondy
country: France
facility: Hôpital Jean Verdier, department of digestive and general surgery
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Corinne Ms Vons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.