Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | Simple closure |
|
| Experimental | Experimental | Simple closure + mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Procedure | Fascial closure with simple polydioxanone suture 2/0 stitches |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Umbilical trocar site hernia incidence | Umbilical trocar site hernia incidence after 6 months and 1 year (clinical assessment) and after 3 years (radiological confirmation) | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Seroma incidence | A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment) | 6 months |
| Hematoma incidence | A localized collection of extravasated blood clotted under the tissue (clinical assessment) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ana Ciscar, MD | Hospital de Mataró | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Mataró | Mataró | Barcelona | 08304 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39207550 | Derived | Ciscar A, Sanchez-Saez E, Vila Tura M, Ruiz de Leon P, Gomez Pallares M, Troyano Escribano D, Abadal Prades M, Mans Muntwyler E, Pereira JA, Badia JM. Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial. Hernia. 2024 Dec;28(6):2187-2194. doi: 10.1007/s10029-024-03124-7. Epub 2024 Aug 29. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
Control will have simple closure while experimental group will have simple closure+mesh
Not provided
Not provided
Not provided
| Experimental |
| Device |
Onlay polypropylene mesh placement (MN mesh) |
|
| 6 months |
| Wound infection incidence | Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically | 6 months |
| Pain presence | Pain presence related to the umbilical wound scored from 0 (no pain) to 10 (severe pain) | 6 months, 1 and 3 years |
| Hospital discharge | When patients leave the hospital after the intervention, measured by hours | 48 hours |
| Operative time | Intervention duration, measured by minutes | 2 hours |
| Return to regular activity | When patient return to job or regular activities after surgery, measured by days | 6 months |
| 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) | 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) | 3 years |