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OpenTrials
Completed

NCT Number: NCT03495557

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

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.

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Key information

Conditions

Incisional Hernia Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Procedure

Fascial closure with simple polydioxanone suture 2/0 stitches

Experimental

Device

Onlay polypropylene mesh placement (MN mesh)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hospital de Mataró

Other

Registry information

Official study title

Evaluation of Port Site Hernia Prevalence After Prophylactic Mesh Placement Following Laparoscopic Cholecystectomy: Randomized Clinical Trial

Acronym: PSHERNIA

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 12, 2018
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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