Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia (EVENTRALAP)

A Prospective, Multicenter, Randomized Trial Comparing Laparoscopy VS Conventional 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.

Study Overview

• Status: Terminated
• Conditions: Incisional Hernia; Umbilical Hernia
• Intervention / Treatment: Procedure: Laparoscopic mesh hernia repair; Procedure: Open anterior approach

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 Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bondy, France, 93140
    • Hôpital Jean Verdier, department of digestive and general surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Laparoscopic approach; group A: Laparoscopic approach	Procedure: Laparoscopic mesh hernia repair; The mesh is intraperitoneal; Other Names: laparoscpic mesh repair of incisional and umbilical hernia
ACTIVE_COMPARATOR: Open approach; group B: Open anterior approach	Procedure: Open 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; Other Names: Conventional treatment of incisional and umbilical hernia

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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
Postoperative fever > 38°5	2 months
Postoperative ileus	2 months
Postoperative phlebitis	2 months
Postoperative pulmonary embolism	2 months
Postoperative urinary infection	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Corinne Ms Vons, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2009
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: September 1, 2009
• First Submitted That Met QC Criteria: September 1, 2009
• First Posted (ESTIMATE): September 2, 2009

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Postoperative complications; Mesh repair; Laparoscopy; Incisional hernia; Umbilical hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia, Ventral; Hernia; Incisional Hernia; Hernia, Umbilical
• Other Study ID Numbers: K060214; 2007-A00374-49 (OTHER: IDRCB)