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

Sponsor
Hospital de Mataró (Other)
Overall Status
Completed
CT.gov ID
NCT03495557
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
44
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Control will have simple closure while experimental group will have simple closure+meshControl 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 :
Jan 1, 2018
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Sep 1, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Umbilical trocar site hernia incidence [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 [6 months]

    A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment)

  2. Hematoma incidence [6 months]

    A localized collection of extravasated blood clotted under the tissue (clinical assessment)

  3. Wound infection incidence [6 months]

    Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically

  4. Pain presence [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 [48 hours]

    When patients leave the hospital after the intervention, measured by hours

  6. Operative time [2 hours]

    Intervention duration, measured by minutes

  7. Return to regular activity [6 months]

    When patient return to job or regular activities after surgery, measured by days

  8. Patient satisfaction [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de Mataró Mataró Barcelona Spain 08304

Sponsors and Collaborators

  • Hospital de Mataró

Investigators

  • Principal Investigator: Ana Ciscar, MD, Hospital de Mataró

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ana Ciscar, MD, Hospital de Mataró
ClinicalTrials.gov Identifier:
NCT03495557
Other Study ID Numbers:
  • PORT SITE HERNIA
First Posted:
Apr 12, 2018
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ana Ciscar, MD, Hospital de Mataró
Hernia
Cholecystectomy
Mesh fixation
Additional relevant MeSH terms:
Hernia
Incisional Hernia

Study Results

No Results Posted as of Mar 23, 2022