Prophylactic Mesh Placement and Incisional Hernia Incidence in Hepatobiliopancreatic Surgery: A Randomized Clinical Trial.

IMPORTANCE

The incidence of incisional hernia after hepatobiliopancreatic surgery could reach 40%. There is a lack of evidence regarding the use of prophylactic mesh in subcostal incisions.

OBJECTIVE

To evaluate whether prophylactic mesh placement during abdominal wall closure reduces the rate of incisional hernias.

DESIGN, SETTING, AND

PARTICIPANTS

This prospective, double-blinded randomized clinical trial was conducted between July 2020 and December 2024 at Virgen Macarena Hospital in Seville, Spain. Patients with 2 or more risk factors for incisional hernias and scheduled for open right subcostal access were considered. Exclusion criteria included emergency surgery, metastatic disease, or unresectable malignant neoplasm identified during the surgery. Follow-up was at 1, 3, 6, 12, and 24 months, postoperatively.

INTERVENTION: Conventional abdominal wall closure vs conventional closure with prophylactic synthetic mesh placement.

MAIN OUTCOMES AND MEASURES: The primary outcome measure was radiological incisional hernia after 12 to 24 months. Secondary outcomes included incision type (Kocher or J incision), postoperative complications, surgical site occurrences rate, postoperative pain, and functional recovery.

RESULTS

There were 144 patients randomized to either conventional closure (n = 69) or synthetic mesh-reinforced closure (n = 75); after 5 patients were excluded because of intraoperative exclusion criteria, 66 patients were assigned to the mesh group and 73 patients to the nonmesh group. At 12-month follow-up, 57 patients in the mesh group and 60 in the nonmesh group were analyzed; 5.2% of patients in the mesh group and 21% in the nonmesh group showed a radiological incisional hernia, with a significant reduction of incisional hernia rate. After 24 months of follow-up, 49 patients in the mesh group and 48 patients in the nonmesh group were analyzed; radiological incisional hernia rate was significantly increased in no-mesh group with 18 (37.5%) patients and 4 (8.1%) patients in mesh group. No differences in surgical site occurrences, postoperative complications, or postoperative pain were identified between the groups. Patients in the mesh group showed significant improvement in functional recovery. This study showed a significantly higher incisional hernia rate when a J incision was performed.

CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that prophylactic mesh placement significantly reduced the overall risk of incisional hernia after hepatobiliary incisions without increasing postoperative complications. These results suggest that to prevent incisional hernias after hepatobiliary surgery through a subcostal incision, the placement of a synthetic mesh during abdominal wall closure should be considered.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT07433439.