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Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy. (PSHERNIA)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495557
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ana Ciscar, Hospital de Mataró

Brief Summary:
A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who present certain risk factors.

Condition or disease Intervention/treatment Phase
Incisional Hernia Procedure: Control Device: Experimental Phase 4

Detailed Description:
Randomized controlled trial. Patients with more than two incisional hernia risk factors (age ≥70, BMI ≥30, diabetes mellitus, fascial enlargement) who undergo elective/emergent cholecystectomy. Control arm: fascial closure with simple PDS 2/0 Stitches. Study arm: fascial closure with simple PDS 2/0 stitches and onlay polypropylene mesh placement. Main outcome umbilical trocar site hernia incidence during a 3 years follow up. Clinical and radiological assessment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Control will have simple closure while experimental group will have simple closure+mesh
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of Port Site Hernia Prevalence After Prophylactic Mesh Placement Following Laparoscopic Cholecystectomy: Randomized Clinical Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Sham Comparator: Control
Simple closure
Procedure: Control
Fascial closure with simple polydioxanone suture 2/0 stitches

Experimental: Experimental
Simple closure + mesh
Device: Experimental
Onlay polypropylene mesh placement (MN mesh)




Primary Outcome Measures :
  1. Umbilical trocar site hernia incidence [ Time Frame: 3 years ]
    Umbilical trocar site hernia incidence after 6 months and 1 year (clinical assessment) and after 3 years (radiological confirmation)


Secondary Outcome Measures :
  1. Seroma incidence [ Time Frame: 6 months ]
    A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment)

  2. Hematoma incidence [ Time Frame: 6 months ]
    A localized collection of extravasated blood clotted under the tissue (clinical assessment)

  3. Wound infection incidence [ Time Frame: 6 months ]
    Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically

  4. Pain presence [ Time Frame: 6 months, 1 and 3 years ]
    Pain presence related to the umbilical wound scored from 0 (no pain) to 10 (severe pain)

  5. Hospital discharge [ Time Frame: 48 hours ]
    When patients leave the hospital after the intervention, measured by hours

  6. Operative time [ Time Frame: 2 hours ]
    Intervention duration, measured by minutes

  7. Return to regular activity [ Time Frame: 6 months ]
    When patient return to job or regular activities after surgery, measured by days

  8. Patient satisfaction [ Time Frame: 3 years ]
    How satisfied/unsatisfied is the patient with the whole process measured by a survey form which classify it in a range from 0 (very unsatisfied) to 5 (very satisfied)

  9. Surgeon satisfaction [ Time Frame: 3 years ]
    How satisfied/unsatisfied is the surgeon with the whole process measured by a survey form which classify it in a range from 0 (very unsatisfied) to 5 (very satisfied)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Laparoscopic cholecystectomy
  • Emergent/elective
  • ≥2 risk factors: diabetes mellitus, age ≥70 years, BMI ≥30, fascial enlargement

Exclusion Criteria:

  • Conversion to laparotomy
  • Emergent re intervention
  • Immunosuppression
  • Umbilical hernia

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): NCT03495557


Contacts
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Contact: Ana Ciscar, MD 0034639293172 aciscar@csdm.cat

Locations
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Spain
Hospital de Mataró Recruiting
Mataró, Barcelona, Spain, 08304
Contact: Ana Ciscar, MD    0034639293172    aciscar@csdm.cat   
Sponsors and Collaborators
Hospital de Mataró
Investigators
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Principal Investigator: Ana Ciscar, MD Hospital de Mataró
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Responsible Party: Ana Ciscar, MD, Hospital de Mataró
ClinicalTrials.gov Identifier: NCT03495557    
Other Study ID Numbers: PORT SITE HERNIA
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana Ciscar, Hospital de Mataró:
Hernia
Cholecystectomy
Mesh fixation
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes