Incisional Hernia
Conditions
Keywords
Hernia, Cholecystectomy, Mesh fixation
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.
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.
Interventions
PROCEDUREControl
Fascial closure with simple polydioxanone suture 2/0 stitches
DEVICEExperimental
Onlay polypropylene mesh placement (MN mesh)
Sponsors
Hospital de Mataró
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Control will have simple closure while experimental group will have simple closure+mesh
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Hematoma incidence | 6 months | A localized collection of extravasated blood clotted under the tissue (clinical assessment) |
| Wound infection incidence | 6 months | Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically |
| Pain presence | 6 months, 1 and 3 years | Pain presence related to the umbilical wound scored from 0 (no pain) to 10 (severe pain) |
| Hospital discharge | 48 hours | When patients leave the hospital after the intervention, measured by hours |
| Seroma incidence | 6 months | A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment) |
| Return to regular activity | 6 months | When patient return to job or regular activities after surgery, measured by days |
| 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) |
| 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) |
| Operative time | 2 hours | Intervention duration, measured by minutes |
Countries
Spain
Outcome results
None listed