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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
Fascial closure with simple polydioxanone suture 2/0 stitches
Onlay polypropylene mesh placement (MN mesh)
Hospital de Mataró
Mataró, Barcelona, Spain
Umbilical trocar site hernia incidence
Umbilical trocar site hernia incidence after 6 months and 1 year (clinical assessment) and after 3 years (radiological confirmation)
Time frame: 3 years
Seroma incidence
A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment)
Time frame: 6 months
Hematoma incidence
A localized collection of extravasated blood clotted under the tissue (clinical assessment)
Time frame: 6 months
Wound infection incidence
Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically
Time frame: 6 months
Pain presence
Pain presence related to the umbilical wound scored from 0 (no pain) to 10 (severe pain)
Time frame: 6 months, 1 and 3 years
Hospital discharge
When patients leave the hospital after the intervention, measured by hours
Time frame: 48 hours
Operative time
Intervention duration, measured by minutes
Time frame: 2 hours
Return to regular activity
When patient return to job or regular activities after surgery, measured by days
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Patient satisfaction
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)
Time frame: 3 years
Surgeon satisfaction
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)
Time frame: 3 years