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

NCT02076984 | Unknown

• 1 other identifier: 11041974
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventral Hernia; Incisional Hernia

Keywords

Ventral hernia; Incisional hernia; Patient affected by ventral or incisional hernias

Outcome Measures

Primary Outcomes (1)

• compare mid and long term results in terms of hernia recurrence

  The primary outcome measure will be to assess the incidence of hernia recurrence in both study groups

  3 years after surgery

Secondary Outcomes (1)

• The secondary outcome measure will be the post-operative pain management

  1 year after surgery

Study Arms (2)

Group A

OTHER

laparoscopic incisional or ventral hernia repair use of lightweight polypropylene mesh fixed by titanium tacks

Procedure: Laparoscopic incisional or ventral hernia repair

Group B

OTHER

laparoscopic incisional or ventral hernia repair use of lightweight polypropylene mesh fixed by U shaped absorbable tacks

Procedure: Laparoscopic incisional or ventral hernia repair

Interventions

Laparoscopic incisional or ventral hernia repair PROCEDURE

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• L3 Hernia width\*
• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome

Latina, 04100, Italy

RECRUITING

Related Publications (2)

• Cavallaro G, Campanile FC, Rizzello M, Greco F, Iorio O, Iossa A, Silecchia G. Lightweight polypropylene mesh fixation in laparoscopic incisional hernia repair. Minim Invasive Ther Allied Technol. 2013 Sep;22(5):283-7. doi: 10.3109/13645706.2013.808228. Epub 2013 Jun 30.

  PMID: 23808370 BACKGROUND

• Silecchia G, Cavallaro G, Raparelli L, Olmi S, Baldazzi G, Campanile FC. Titanium versus absorbable tacks comparative study (TACS): a multicenter, non-inferiority prospective evaluation during laparoscopic repair of ventral and incisional hernia: study protocol for randomized controlled trial. Trials. 2015 Jun 4;16:249. doi: 10.1186/s13063-015-0779-x.

  PMID: 26037907 DERIVED

MeSH Terms

Conditions

Hernia, Ventral; Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Central Study Contacts

Giuseppe Cavallaro, MD, PhD

CONTACT

giuseppe.cavallaro@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gianfranco Silecchia

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 4, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2018
• Last Updated: June 1, 2015

Record last verified: 2015-05

Locations

IT (1)