Prophylactic sublay non-absorbable mesh positioning following midline laparotomy in a clean-contaminated field: randomized clinical trial (PROMETHEUS). Issue 6 (28th April 2021)

• Record Type: Journal Article
• Authors: Pizza, F; D'Antonio, D; Ronchi, A; Lucido, F S; Brusciano, L; Marvaso, A; Dell'Isola, C; Gambardella, C
• Is Part Of: British journal of surgery. Volume 108:Issue 6(2021)
• Page Start: 638
• Page End: 643
• Publication Date: 2021-04-28
• Subjects: Surgery -- Periodicals; 617.005
• DOI: 10.1093/bjs/znab068
• Languages: English
• ISSNs: 0007-1323

Abstract

Abstract: Background: Incisional hernia is a frequent postoperative complication after midline laparotomy. Prophylactic mesh augmentation in abdominal wall closure after elective surgery is recommended, but its role in emergency surgery is less well defined. Methods: This prospective randomized trial evaluated the incidence of incisional hernia in patients undergoing urgent midline laparotomy for clean-contaminated surgery. Closure using a slowly absorbable running suture was compared with closure using an additional sublay mesh (Parietex ProGrip™). Patients were randomized just before abdominal wall closure using computer-generated permuted blocks. Patients, care providers, staff collecting data, and those assessing the endpoints were all blinded to the group allocation. Patients were followed up for 24 months by means of clinical and ultrasonographic evaluations. Results: From January 2015 to June 2018, 200 patients were randomized: 100 to primary closure (control group) and 100 to Parietex ProGrip™ mesh-supported closure (mesh group). Eight patients in the control group and six in the mesh group were lost to follow-up. By 24 months after surgery, 21 patients in the control group and six in the mesh group had developed incisional hernia ( P = 0.002). There was no difference between groups in the incidence of haematoma (2 versus 5; P = 0.248) and superficial wound infection (4 versus 5; P = 0.733). Multivariable analysis confirmed the role of mesh in preventing incisional hernia (odds ratio 0.11, 95 per cent c.i. 0.03 to 0.37; P < 0.001). One patient in the mesh group required mesh removal because of deep infection. Conclusion: Prophylactic mesh-augmented abdominal wall closure after urgent laparotomy in clean-contaminated wounds is safe and effective in reducing the incidence of incisional hernia. Registration number: NCT04436887 (http://www.clinicaltrials.gov ). Abstract : A prospective randomized controlled trial was conducted to compare the widely recommended midline laparotomy closure using a slowly absorbable running suture to closure with a sub-lay mesh (Parietex Progrip), in patients undergoing midline urgent laparotomy for clean-contaminated surgery. The patients were followed-up for 24 months with clinical and ultrasonographical evaluation during outpatient visits. Prophylactic reinforcement of midline abdominal wall, using a Progrip Parietex mesh in the retro-muscular position at the time of urgent laparotomy in clean-contaminated wounds is safe and effective in reducing the incidence of IH, although larger studies with longer follow-up are required.