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

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ClinicalTrials.gov Identifier: NCT01802229
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : March 1, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Port-site Hernia Procedure: Prophylactic mesh placement Procedure: Fascial suture Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : January 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Incidence of port-site hernia [ Time Frame: 12 months ]
    Comparison of incidence of port-site hernia between patiensts with and without prophylactic mesh placement

Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: 12 months ]
    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

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802229

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

Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Professor, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT01802229     History of Changes
Other Study ID Numbers: 2013-002
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: March 1, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Pathological Conditions, Anatomical