Prevention of Umbilical Port-site Hernia After Laparoscopic Cholecystectomy Using a Prosthetic Mesh Versus Simple Suture

This study has been completed.
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche Identifier:
First received: February 27, 2013
Last updated: February 28, 2013
Last verified: February 2013
The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of umbilical port site.

Condition Intervention Phase
Port-site Hernia
Procedure: Prophylactic mesh placement
Procedure: Fascial suture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Hospital General Universitario Elche:

Primary Outcome Measures:
  • Incidence of port-site hernia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Comparison of incidence of port-site hernia between patiensts with and without prophylactic mesh placement

Secondary Outcome Measures:
  • Postoperative pain [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Evaluation of different pain perception in patients with and without prophylactic mesh placement, determined in the postoperative course and at 1, 6 and 12 months after surgery

Enrollment: 106
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Suture
Umbilical port-site closure with simple suture of the fascia.
Procedure: Fascial suture
The port-site hole is closed with simple suture of the fascia
Experimental: Prophylactic mesh
Umbilical port-site closure with mesh placement
Procedure: Prophylactic mesh placement
Placement of a Omega 3 mesh, fixed to the border of the fascia


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 65 years
  • BMI > 30 Kg/m2
  • Diabetes mellitus
  • Lung disease
  • Elective laparoscopic cholecystectomy

Exclusion Criteria:

  • Umbilical hernia
  • Previous laparotomy
  • Conversion to open procedure
  • Loss during the follow up
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Please refer to this study by its identifier: NCT01802229

Hospital general Universitario de Elche
Elche, Alicante, Spain, 03203
Sponsors and Collaborators
Hospital General Universitario Elche
  More Information

No publications provided

Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Professor, Hospital General Universitario Elche Identifier: NCT01802229     History of Changes
Other Study ID Numbers: 2013-002 
Study First Received: February 27, 2013
Last Updated: February 28, 2013
Health Authority: Spain: Ethics Committee processed this record on February 10, 2016