Trial record 3 of 177 for:    Open Studies | Hernia NOT disc

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 June 2014 by University of Roma La Sapienza
Sponsor:
Collaborators:
Giuseppe Cavallaro, MD PhD. University of Roma La Sapienza
Luigi Raparelli, MD. G.B. Grassi Hospital, Ostia (Rome)
Fabio Cesare Campanile, MD. Andosilla Hospital, Civita Cavtellana (Viterbo)
Stefano Olmi, MD. Gruppo Ospedaliero San Donato, Milano
Diego Cuccurullo, MD. Monaldi Hospital, Napoli
Gianandrea Baldazzi, MD. Abano Terme Hospital
Information provided by (Responsible Party):
Gianfranco Silecchia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT02076984
First received: February 28, 2014
Last updated: June 15, 2014
Last verified: June 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LAPAROSCOPIC VENTRAL HERNIA REPAIR BY LIGHTWEIGHT POLYPROPYLENE MESH. A PROSPECTIVE ITALIAN MULTICENTRIC RANDOMIZED STUDY COMPARING TWO FIXATION DEVICES: TITANIUM SPIRAL TACKS vs ABSORBABLE TACKS

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02076984

Contacts
Contact: Giuseppe Cavallaro, MD, PhD giuseppe.cavallaro@uniroma1.it

Locations
Italy
Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome Recruiting
Latina, Italy, 04100
Contact: Giuseppe Cavallaro, MD PhD    07736513304 ext 0039    giuseppe.cavallaro@uniroma1.it   
Principal Investigator: Gianfranco Silecchia, MD         
Sponsors and Collaborators
University of Roma La Sapienza
Giuseppe Cavallaro, MD PhD. University of Roma La Sapienza
Luigi Raparelli, MD. G.B. Grassi Hospital, Ostia (Rome)
Fabio Cesare Campanile, MD. Andosilla Hospital, Civita Cavtellana (Viterbo)
Stefano Olmi, MD. Gruppo Ospedaliero San Donato, Milano
Diego Cuccurullo, MD. Monaldi Hospital, Napoli
Gianandrea Baldazzi, MD. Abano Terme Hospital
  More Information

Publications:
Responsible Party: Gianfranco Silecchia, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02076984     History of Changes
Other Study ID Numbers: 11041974
Study First Received: February 28, 2014
Last Updated: June 15, 2014
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on July 26, 2014