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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01802229
First Posted: March 1, 2013
Last Update Posted: March 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche:

Primary Outcome Measures:
  • 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:
  • 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


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

  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Locations
Spain
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 Submitted: February 27, 2013
First Posted: March 1, 2013
Last Update Posted: March 1, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical