Prophylactic sublay non-absorbable mesh positioning following midline laparotomy in a clean-contaminated field: randomized clinical trial (PROMETHEUS)

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). Graphical Abstract An RCT was conducted to compare the widely recommended midline laparotomy closure using a slowly absorbable running suture with closure using a sublay mesh (Parietex ProGrip™), in patients undergoing urgent midline laparotomy for clean-contaminated surgery. Patients were followed up for 24 months with clinical and ultrasonographic evaluation during outpatient visits. Prophylactic reinforcement of the midline abdominal wall, using a ProGrip™ Parietex mesh in the retromuscular position, at the time of urgent laparotomy in clean-contaminated wounds was safe and effective in reducing the incidence of incisional hernia, although larger studies with longer follow-up are required.

Nationwide analysis of laparoscopic groin hernia repair in Italy from 2015 to 2020

“…Still, since there is a growing interest in using alternative materials for mesh, it could be interesting to make a further evaluation on the impact of costs on outcomes of their implementation into clinical practice. [20,21] Finally, as reported by Bracale et al, one of the major limitations in comparing laparoendoscopic and open surgical techniques is that scientific papers often compare bilateral vs monolateral hernias. [9] From the data analysis, we can observe that there has been a progressive increase in the laparoendoscopic approach to inguinal hernia repair in Italy, together with an increase in the number of emergency operations performed for incarcerated hernias, showing a boost in confidence in the minimally invasive approach to inguinal hernioplasty even in more complex situations.…”

“…Still, since there is a growing interest in using alternative materials for mesh, it could be interesting to make a further evaluation on the impact of costs on outcomes of their implementation into clinical practice. [ 20 , 21 ]…”

Does small bite closure reduce the incidence of incisional hernia compared to standard mass closure for midline laparotomy?

“…Over the last decade there has been intensive studies and trials on the prevention and reduction of incisional hernias and the main focus was on the technique as it is the only independent factor that is controlled by the surgeon. Many techniques have been explored, including use of prophylactic mesh [ 9 ], distance of stitches from sheath edge and each other (5 mm instead of the conventional 10 mm in mass closure), and different types of suture materials and length [ 10 ].…”

Umbilical hernia: could it be the ‘canary in the coal mine’ for a more significant abdominal wall problem?

“…Several papers have discussed the benefits of prophylactic mesh closure in midline laparotomy 30,31 . Pizza et al 32 . demonstrated that prophylactic mesh in clean contaminated wounds was safe and reduced the incidence of incisional hernia following laparotomy.…”