Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia

Incisional Hernia Clinical Trial

— EVENTRALAP  

Official title:

A Prospective, Multicenter, Randomized Trial Comparing Laparoscopy VS Conventional Mesh Repair of Incisional and Umbilical Hernia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00970515
• Other study ID #: K060214
• Secondary ID: 2007-A00374-49
• Status: Terminated
• Phase: N/A
• Start date: November 2009
• Est. completion date: April 2013

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 98
• Est. completion date: April 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical
• Incisional Hernia
• Umbilical Hernia

Intervention

Procedure:
• Laparoscopic mesh hernia repair
The mesh is intraperitoneal
• 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

Locations

Country	Name	City	State
France	Hôpital Jean Verdier, department of digestive and general surgery	Bondy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

Proske JM, Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):360-4. Review. French. — View 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. Review. French. — View Citation

Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):366-70. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis		2 months
Primary	Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage		2 months
Secondary	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
Secondary	Postoperative fever > 38°5		2 months
Secondary	Postoperative ileus		2 months
Secondary	Postoperative phlebitis		2 months
Secondary	Postoperative pulmonary embolism		2 months
Secondary	Postoperative urinary infection		2 months
Secondary	Duration of hospital stay		2 months
Secondary	Duration of drainage		2 months
Secondary	Mesh infection		24 months
Secondary	Peritonitis due to intraperitoneal mesh		24 months
Secondary	Occlusion due to intra peritoneal mesh		2 months
Secondary	Recurrence of incisional or umbilical hernia		24 months
Secondary	Trocar site hernia		24 months