Prophylactic sublay non-absorbable mesh positioning following midline laparotomy in a clean-contaminated field: randomized clinical trial (PROMETHEUS)
- 28 April 2021
- journal article
- research article
- Published by Oxford University Press (OUP) in British Journal of Surgery
- Vol. 108 (6), 638-643
- https://doi.org/10.1093/bjs/znab068
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).This publication has 23 references indexed in Scilit:
- A Cost-Utility Assessment of Mesh Selection in Clean-Contaminated Ventral Hernia RepairPlastic and Reconstructive Surgery, 2016
- European Hernia Society guidelines on the closure of abdominal wall incisionsHernia, 2015
- Prophylactic synthetic mesh can be safely used to close emergency laparotomies, even in peritonitisSurgery, 2014
- Infected large pore meshes may be salvaged by topical negative pressure therapyHernia, 2012
- EuraHS: the development of an international online platform for registration and outcome measurement of ventral abdominal wall hernia repairHernia, 2012
- CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trialsInternational Journal of Surgery, 2011
- Randomized clinical trial of mesh versus sutured wound closure after open abdominal aortic aneurysm surgeryBritish Journal of Surgery, 2010
- Elective Midline Laparotomy ClosureAnnals of Surgery, 2010
- Incisional hernia: a reviewNigerian Journal of Medicine, 2006
- Meta-analysis of techniques for closure of midline abdominal incisionsBritish Journal of Surgery, 2002