NCT01802229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
Last Updated

March 1, 2013

Status Verified

February 1, 2013

Enrollment Period

1.9 years

First QC Date

February 27, 2013

Last Update Submit

February 28, 2013

Conditions

Port-site Hernia

Outcome Measures

Primary Outcomes (1)

  • Incidence of port-site hernia

    Comparison of incidence of port-site hernia between patiensts with and without prophylactic mesh placement

    12 months

Secondary Outcomes (1)

  • Postoperative pain

    12 months

Study Arms (2)

Suture

ACTIVE COMPARATOR

Umbilical port-site closure with simple suture of the fascia.

Procedure: Fascial suture

Prophylactic mesh

EXPERIMENTAL

Umbilical port-site closure with mesh placement

Procedure: Prophylactic mesh placement

Interventions

Prophylactic mesh placementPROCEDURE

Placement of a Omega 3 mesh, fixed to the border of the fascia

Prophylactic mesh
Fascial suturePROCEDURE

The port-site hole is closed with simple suture of the fascia

Suture

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Umbilical hernia
  • Previous laparotomy
  • Conversion to open procedure
  • Loss during the follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital general Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2013

First Posted

March 1, 2013

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 1, 2013

Record last verified: 2013-02

Locations

ES(1)