Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia

Not Applicable

Terminated

• Conditions: Incisional Hernia; Umbilical Hernia
• Interventions: Procedure: Laparoscopic mesh hernia repair; Procedure: Open anterior approach

• Registration Number: NCT00970515
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Study Start: 2009-11
• Primary Completion: 2011-04
• Study Completion: 2013-04
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Age > 18
• Incisional or umbilical hernia over 2 cm and less than 6 cm in diameter

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic approach	Laparoscopic mesh hernia repair	group A: Laparoscopic approach
Open approach	Open anterior approach	group B: Open anterior approach

Primary Outcome Measures

Name	Time	Method
Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis	2 months
Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage	2 months

Secondary Outcome Measures

Name	Time	Method
Postoperative fever > 38°5	2 months
Postoperative phlebitis	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
Duration of hospital stay	2 months
Mesh infection	24 months
Postoperative ileus	2 months
Duration of drainage	2 months
Occlusion due to intra peritoneal mesh	2 months
Postoperative pulmonary embolism	2 months
Postoperative urinary infection	2 months
Recurrence of incisional or umbilical hernia	24 months
Trocar site hernia	24 months
Peritonitis due to intraperitoneal mesh	24 months

Trial Locations

Locations (1)

Hôpital Jean Verdier, department of digestive and general surgery; 🇫🇷 Bondy, France