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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
ClinicalTrials.gov Identifier:
NCT01802229
First received: February 27, 2013
Last updated: February 28, 2013
Last verified: February 2013
  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
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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: NCT01802229

Locations
Spain
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
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 21, 2014