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

Primary Purpose

Incisional Hernia, Umbilical Hernia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laparoscopic mesh hernia repair
Open anterior approach
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incisional Hernia focused on measuring Laparoscopy, Incisional hernia, Umbilical hernia, Mesh repair, Postoperative complications

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Jean Verdier, department of digestive and general surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic approach

Open approach

Arm Description

group A: Laparoscopic approach

group B: Open anterior approach

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 1, 2009
Last Updated
June 14, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00970515
Brief Title
Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia
Acronym
EVENTRALAP
Official Title
A Prospective, Multicenter, Randomized Trial Comparing Laparoscopy VS Conventional Mesh Repair of Incisional and Umbilical Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
lack of recrutment
Study Start Date
November 2009 (Actual)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia, Umbilical Hernia
Keywords
Laparoscopy, Incisional hernia, Umbilical hernia, Mesh repair, Postoperative complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic approach
Arm Type
Experimental
Arm Description
group A: Laparoscopic approach
Arm Title
Open approach
Arm Type
Active Comparator
Arm Description
group B: Open anterior approach
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic mesh hernia repair
Other Intervention Name(s)
laparoscpic mesh repair of incisional and umbilical hernia
Intervention Description
The mesh is intraperitoneal
Intervention Type
Procedure
Intervention Name(s)
Open anterior approach
Other Intervention Name(s)
Conventional treatment of incisional and umbilical hernia
Intervention Description
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
Primary Outcome Measure Information:
Title
Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis
Time Frame
2 months
Title
Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage
Time Frame
2 months
Secondary Outcome Measure Information:
Title
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
Title
Postoperative fever > 38°5
Time Frame
2 months
Title
Postoperative ileus
Time Frame
2 months
Title
Postoperative phlebitis
Time Frame
2 months
Title
Postoperative pulmonary embolism
Time Frame
2 months
Title
Postoperative urinary infection
Time Frame
2 months
Title
Duration of hospital stay
Time Frame
2 months
Title
Duration of drainage
Time Frame
2 months
Title
Mesh infection
Time Frame
24 months
Title
Peritonitis due to intraperitoneal mesh
Time Frame
24 months
Title
Occlusion due to intra peritoneal mesh
Time Frame
2 months
Title
Recurrence of incisional or umbilical hernia
Time Frame
24 months
Title
Trocar site hernia
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Ms Vons, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Jean Verdier, department of digestive and general surgery
City
Bondy
ZIP/Postal Code
93140
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18645551
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.
Results Reference
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PubMed Identifier
15738845
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.
Results Reference
background
PubMed Identifier
15738844
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.
Results Reference
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Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia

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