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Titanium vs Absorbable Tacks for Mesh Fixation in Laparoscopic Incisional and Ventral Hernia Repair

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by University of Roma La Sapienza
Information provided by (Responsible Party):
Gianfranco Silecchia, University of Roma La Sapienza Identifier:
First received: February 28, 2014
Last updated: May 29, 2015
Last verified: May 2015

Background: Laparoscopic repair of ventral hernias has gained popularity, since many studies and a recent meta-analysis have reported encouraging results and recurrence rates similar to open repair. The choice of the mesh and fixation methods is of paramount importance during laparoscopic approach, and nowadays, lightweight macropore meshes specifically designed for laparoscopic approach represent the first choice in several studies, due to the biomechanical properties and the optimal integration into the abdominal wall. No data with statistical relevance exist on the choice of fixation methods.

Primary end point of the present Italian multicentric prospective randomized trial is to evaluate the safety and effectiveness of two different tacks to fix the lightweight polypropylene mesh (Physiomesh™) during laparoscopic incisional hernia repair: metallic spiral tacks (Protack™) vs absorbable "U" shaped tacks (Securestrap™)

Design of the Study: 200 patients with ventral hernia will be randomized into two groups:

Group A patients will be submitted to laparoscopic repair by Physiomesh fixed by Protack; Group B patients will be submitted to laparoscopic repair by Physiomesh fixed by Securestrap.

Blind randomization will be guaranteed by an on-line software with specific key access for every surgical unit participating in the study. Patients demographics and characteristics, preoperative studies, intraoperative and postoperative results and complications, as well as scheduled follow-up will be recorded and uploaded to the database. Data represented by continuous variables will be expressed as arithmetic mean +/- standard deviation. Other data will be expressed as geometric mean +/- 95% confidence interval. Data representing low incidence events will be expressed as number and percentage of occurrence for each group. Statistical significance for all analyses will be indicated by a p value of 0.05 or less.

Condition Intervention
Ventral Hernia
Incisional Hernia
Procedure: Laparoscopic incisional or ventral hernia repair

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • compare mid and long term results in terms of hernia recurrence [ Time Frame: 3 years after surgery ]
    The primary outcome measure will be to assess the incidence of hernia recurrence in both study groups

Secondary Outcome Measures:
  • The secondary outcome measure will be the post-operative pain management [ Time Frame: 1 year after surgery ]

Estimated Enrollment: 200
Study Start Date: June 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
laparoscopic incisional or ventral hernia repair use of lightweight polypropylene mesh fixed by titanium tacks
Procedure: Laparoscopic incisional or ventral hernia repair
Group B
laparoscopic incisional or ventral hernia repair use of lightweight polypropylene mesh fixed by U shaped absorbable tacks
Procedure: Laparoscopic incisional or ventral hernia repair

  Show Detailed Description


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Table 1: Inclusion criteria Hernia site*

  • M2
  • M3
  • M4
  • L2
  • L3 Hernia width*
  • W1
  • W2
  • No previous vnetral/incisional hernia repair (R0)*
  • No incarcerated/strangulated hernia
  • No contaminated field or bowel resection during repair
  • BMI < 35
  • Age between 18 and 75 years old
  • No severe COPD
  • No autoimmune disease under corticosteroids treatment
  • No cirrhosis Child B or C
  • No uncontrolled diabetic (Glycated Hemoglobin < 7)

    • According to: Muysoms FE, et al. Classification of primary and incisional abdominal wall hernias: Hernia 2009; 13: 407-414

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02076984

Contact: Giuseppe Cavallaro, MD, PhD

Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome Recruiting
Latina, Italy, 04100
Contact: Giuseppe Cavallaro, MD PhD    07736513304 ext 0039   
Principal Investigator: Gianfranco Silecchia, MD         
Sponsors and Collaborators
University of Roma La Sapienza
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gianfranco Silecchia, University of Roma La Sapienza Identifier: NCT02076984     History of Changes
Other Study ID Numbers: 11041974
Study First Received: February 28, 2014
Last Updated: May 29, 2015

Keywords provided by University of Roma La Sapienza:
Ventral hernia
Incisional hernia
Patient affected by ventral or incisional hernias

Additional relevant MeSH terms:
Hernia, Ventral
Incisional Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes processed this record on May 23, 2017