Bravo‑Salva et al. BMC Surg (2021) 21:243 https://doi.org/10.1186/s12893-021-01243-x RESEARCH ARTICLE Open Access Long‑term follow‑up of prophylactic mesh reinforcement after emergency laparotomy. A retrospective controlled study A. Bravo‑Salva1,2, N. Argudo‑Aguirre1,2, A. M. González‑Castillo1,4, E. Membrilla‑Fernandez1,3, J. J. Sancho‑Insenser1,3, L. Grande‑Posa1,3, M. Pera‑Román1,3 and J. A. Pereira‑Rodríguez1,2* Abstract Background: Prevention of incisional hernias with a prophylactic mesh in emergency surgery is controversial. The present study aimed to analyze the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies. Methods: This study was a registered (NCT04578561) retrospective analysis of patients who underwent an emer‑ gency midline laparotomy between January 2009 and July 2010 with a follow-up period of longer than 2 years. Long- term outcomes and risk factors for the development of incisional hernias between patients who received a prophy‑ lactic reinforcement mesh (Group M) and suture (Group S) were compared. Results: From an initial 266 emergency midline laparotomies, 187 patients were included. The median follow-up time was 64.4 months (SD 35). Both groups had similar characteristics, except for a higher rate of previous operations (62 vs. 43.2%; P = 0.01) and operation due to a revision laparotomy (32.5 vs.13%; P = 0.02) in the M group. During follow-up, 29.9% of patients developed an incisional hernia (Group S 36.6% vs. Group M 14.3%; P = 0.002). Chronic mesh infections were diagnosed in 2 patients, but no mesh explants were needed, and no patient in the M group developed chronic pain. Long-term risk factors for incisional hernia were as follows: smoking (HR = 2.47; 95% CI 1.318– 4.624; P = 0.05), contaminated surgery (HR = 2.98; 95% CI 1.142–7.8; P = 0.02), surgical site infection (SSI; HR = 3.83; 95% CI 1.86–7.86; P = 0.001), and no use of prophylactic mesh (HR = 5.09; 95% CI 2.1–12.2; P = 0.001). Conclusion: Incidence of incisional hernias after emergency midline laparotomies is high and increases with time. High-risk patients, contaminated surgery, and surgical site infection (SSI) benefit from mesh reinforcement. Prophylac‑ tic mesh use is safe and feasible in emergencies with a low long-term complication rate. Trial registration: NCT04578561. www.​clini​caltr​ials.​gov Keywords: Hernia prevention, Emergency Surgery, Prophylactic mesh, Contaminated surgery and long-term follow up Background In the era of minimally invasive surgery, midline lapa- rotomies are still a common approach in emergen- cies [1]. This type of incision leads to a high incidence *Correspondence: jose.pereira@upf.edu of incisional hernias (IHs) when compared with other 2 Departament de Ciències, Experimentals I de La Salut, Universitat approaches such as lateral laparotomies [2–4]. When a Pompeu Fabra, Dr. Aiguader 88, 08003 Barcelona, Spain Full list of author information is available at the end of the article midline laparotomy is performed in high-risk patients, © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://​creat​iveco​mmons.​org/​licen​ses/​by/4.​0/. The Creative Commons Public Domain Dedication waiver (http://​creat​iveco​ mmons.​org/​publi​cdoma​in/​zero/1.​0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Bravo‑Salva et al. BMC Surg (2021) 21:243 Page 2 of 8 this incidence increases; one of these high-risk situations concomitant hernia repair, those who received inci- is emergency surgery, and the incidence of IHs after an sions outside the midline, those with delayed abdominal emergency midline laparotomy (EML) ranges from 18 closure, those who died in the immediate postoperative to 54% [5–7]. It has been demonstrated that prophylac- period, and a minimum 2 years of follow-up. tic mesh reinforcement after midline elective laparotomy Surgical technique: Closure of incision was performed is useful in reducing IH, especially in high-risk patients by running suture of double loop number 1 polydiox- [8–13]. anone (PDS, Ethicon, Bridgewater, NJ), and in some Emergency surgery is a well-known risk factor for IHs, cases, retention polypropylene number 1 (Ethilon, Ethi- but its prevention has been poorly studied, and the main con) suture was used. In group M, prophylactic syn- point investigated thus far has been the closure tech- thetic partially absorbable lightweight large pore mesh nique [14]. In a recent study, a standardized technique of (Ultrapro, Ethicon) placed ‘‘onlay’’ was used as reinforce- closure showed a reduction in the incidence of IHs and ment [23]. The overlap involved 3-cm wide on each side burst abdomen [15, 16]. Mesh reinforcement in emergen- of the incision and superior and inferior incisional lim- cies is controversial, and there is a lack of high-quality its. Mesh fixation was performed using a double crown studies on this issue. On the one hand, a recent meta- of fascial staples (DFS; Autosuture, Covidien, MA), with analysis concluded that there was inadequate evidence to additional polypropylene 2/0 stitches (Prolene; Ethicon) recommend its use in a standardized approach [17]; on In all mesh group patients, closed suction onlay drains the other hand, a randomized control trial demonstrated were placed. that prophylactic mesh in EMLs reduced the incidence of All postoperative evaluations were performed by clini- dehiscence fascia when analyzing short-term outcomes, cal appointment with abdominal exploration from a but with a higher incidence of surgical site infection (SSI) surgeon. The definition of an IH was according to the in the mesh group [18]. Surgical site occurrences (SSO) description of the EHS: “Any abdominal wall gap with or and acute and chronic infection are the main concerns without a bulge in the area of a postoperative scar per- for surgeons when implementing a prophylactic mesh, ceptible or palpable by clinical examination or imaging” especially in the emergency setting, apart from other [24]. IH diagnosis was determined through clinical explo- complications such as chronic pain and intestinal fis- ration, and in cases of diagnostic uncertainty, abdomi- tulas [19]. Despite these concerns, there have been no nal ultrasound (US) or computed tomography (CT) was studies evaluating the long-term complications of mesh performed. In addition, all the abdominal CTs or USs reinforcement in EMLs, although some recent long-term performed during the follow-up due to other causes studies in elective cases have demonstrated its safety and (oncological follow-up, for instance) were revised for efficacy in reducing the incidence of IHs with a long-term asymptomatic IH detection [25, 26]. Chronic pain was follow up [20]. The European Hernia Society Guidelines defined as significant pain persisting after 3 months of (EHS) recommendation is to use prophylactic mesh in intervention [27, 28]. Chronic mesh infection was defined high-risk patients, but no recommendation is given for as the presence of local symptoms such as inflamed skin, the closure of EMLs due to a lack of data [21]. Hence, we chronic leaking, fistula, abscess, or prosthetic exposure, hypothesize that prophylactic mesh may also be useful in persisting despite conservative medical management EMLs to prevent IHs. including antibiotics and local care [29]. The main objective of this study was to analyze long- In the statistical analysis, numeric variables were pre- term results and complications after prophylactic mesh sented as mean and standard deviation, and categorical implantation during emergency midline laparotomies. variables were reported as proportions. The association between qualitative variables was assessed using contin- Methods gency tables (chi-squared test and Fisher’s exact tests, We designed a retrospective analysis following the when necessary), and the quantitative tests were con- STROBE guideline statements [22] for a cohort of ducted using Student’s t-test for unpaired data or the patients who underwent emergency midline laparoto- Mann–Whitney U test when necessary. The normality of mies in the period between January 2009 and July 2010 the distribution of numeric variables was assessed using in a University Hospital. We included all consecutive normal QQ plots. Odds ratios (OR) and confidence inter- patients from January 2009 to July 2010 with at least vals (CI) for IH incidence in univariate analysis were cal- 2 years of follow-up and compared those who received a culated for each group. prophylactic onlay mesh (Group M) with those in whom A multivariate analysis of the risk factors for IHs in the the laparotomy was closed only with suture (Group S). general cohort was conducted. The predictive capacity of The eligibility criteria were as follows: undergoing each variable and its independence were analyzed using emergency midline laparotomy excluding those with a Cox regression model. Survival curves for hernia-free Bravo‑Salva et al. BMC Surg (2021) 21:243 Page 3 of 8 survival were estimated by a Cox survival analysis Long-term results of the follow-up are summarized method in the whole cohort. Statistical analysis was per- in Table 2. A total of 56 (29.9%) IHs were diagnosed, of formed using Software package SPSS v.20.0 (IBM Inc, which 41 were diagnosed during short-term and 15 dur- Rochester, MN). ing long-term follow-up (8 in the M group vs. 48 in the The Local Clinical Research Ethics Committee approval S group; P = 0.002). From 38 patients where additional was obtained and the observational study protocol was retention sutures were used (37 in S group and 1 in M registered with the NCT04578561 code of ClinicalTrials. group) 15 IHs were diagnosed in those patients (39.5% gov database [30]. of the subgroup patients) all of them from S group. In long-term follow up 78(41.1%) patients had radiological Results exploration. A total of 187 patients from the initial cohort of 266 During follow-up, 14 IHs (25%) were repaired, 12 in patients were included. The causes for exclusion were as the S group and two in the M group; three recurrences follows: 37 postoperative death, 4 death during follow- occurred: two in the M group and one in the S group. up (non-mesh related), and 38 lost to follow-up (Fig. 1). The causes of avoiding/delaying hernia repair were as The median follow-up period was 64.4 months (SD 35.2). follows: 10 patients had no clinical symptoms and IH The demographic characteristics of the patients, opera- was diagnosed in revision CTs, 9 patients died during tions, and diagnostics are shown in Table 1. Both groups follow-up for non-mesh-related complications without showed similar characteristics, except for higher rate of hernia repair, 8 patients received watchful waiting man- previous abdominal operations (62 vs. 43.2%; P = 0.02) agement due to an absence of symptoms and/or severe and revision laparotomy as indication (32.5 vs.15%; comorbidities, seven patients rejected hernia repair, six P = 0.02) in group M. patients were lost to follow-up after IH diagnosis, and Fig. 1 Study’s flow chart Bravo‑Salva et al. BMC Surg (2021) 21:243 Page 4 of 8 Table 1 Comparative analysis of demographics, comorbidities, and surgery characteristics Total (N = 187) Group M (N = 56) Group S (N= 131) P value Demographic variables Age,yr (SD) 65.4 (16.8) 68.39(15.2) 64.16(17.34) 0.51 Sex male/female (%) 84/103 (44.9/55.1) 23/33 (27.4/32) 61/70(72.6/68) 0.29 ASA score I-II/III-IV 82/105 (43.9/56.1) 21/35 (25.6/33.3) 61/70(74.4/66.7) 0.71 Risk factors for incisional hernia (%) Smoking 71 (30) 20 (35.2%) 51 (38.9) 0.67 COPD 29 (15.3) 12 (21.4) 17 (13) 0.11 DM 33 (17.6) 24 (18.3) 9 (16.1) 0.71 Inmunosupresion 20 (10.7) 14 (10.7) 6 (10.7) 0.99 Previous abdominal operation 92 (49.2) 35 (62) 57 (43.2) 0.01 Obesity ( BMI > 30) 62 (34.4) 21 (38.9) 41 (32.5) 0.41 Operative Diagnostics (%) Neoplasm 38 (20.3) 11 (29.6) 27 (20.6) 0.57 Obstruction 42 (22.5) 19 (45.2) 23 (54.3) 0.14 Peritonitis 72 (38.5) 21 (37.5) 51 (38.8) 0.85 Hemorrhage 23 (12.3) 4 (7.1) 19 (14.5) 0.16 Ischemia 11 (5.9) 1 (1.8) 10 (7.6) 0.12 Type of surgery Revision laparotomy (%) 49 (26.2) 21 (32.5) 28 (15) 0.02 Table 2 Long-Term Outcomes (> 2 year follow-up) N (%) General; N = 187 (100) Group M; N = 56 (29.1) Group S; N = 131 (70.9) P value Incisional hernia 56 (29.9) 8(14.3) 48 (36.6) 0.002 Long-term incisional hernia diagnosis* 15 (32.1) 3 (37.5) 12 (28.2) 0.53 Chronic pain 0 0 – – Chronic infection 2 (1.3) 2 (4.3) – – Mesh removal 0 0 – – Incisional hernia repair 14 (25.0) 2 (25.0) 12 (25.0) 0.03 Recurrence after incisional hernia repair 3 (21.4) 2 (100) 1 (8.3) 0.39 *IH diagnosis after 2 years of postoperative follow-up two IHs appeared after a new iterative laparotomy dur- None of the patients of both groups were diagnosed ing the follow-up period. with chronic pain during follow-up. Chronic mesh infections were diagnosed in two The incidence and risk of IH by subgroup analysis is patients; both patients were treated without the need shown in Table 3. Wide differences in the incidence were for surgical mesh removal, and complete healing was observed in the analysis of high-risk subgroups. In opera- achieved at 4 and 12 months after surgery. In both tions related to cancer, no incidence of hernia was diag- cases, mesh removal was offered but rejected by the nosed in the M group as compared to 44.4% incidence patients due to the high risk of surgical complications. (P = 0.008) in the S group. In patients with SSI, only one One case of chronic wound infection was a patient with patient in the M group had IH (7.7%) as compared to 17 colon resection due to obstructive sigmoid tumor, and patients (73.9%; P < 0.001) in the S group. In the other in the second case, the patient received small bowel subgroups, the use of prophylactic mesh had a statisti- resection and adhesiolysis. Both patients had high cally significant lower incidence of IH, except in obese intraoperative peritoneal contamination, and both patients where no statistical differences (p = 0.054) were presented postoperative SSI that was treated initially observed, but the incidence was also lower. with debridement and saline irrigations. Both patients Multivariate analysis of the risk factors for IHs achieved healing at 4th and 12th postoperative months. were as follows: smoking (HR = 2.47; 95% CI 1.318– 4.624; P = 0.05), contaminated surgery (groups Bravo‑Salva et al. BMC Surg (2021) 21:243 Page 5 of 8 Table 3 Incidence and risk (not using prophylactic mesh) of incisional hernia by long-term follow-up of subgroups General; N = 187 Group M; N = 56 Group S; N = 131 OR 95% CI P value (29.1) (70.9) General (187) 56 (29.9) 8 (14.3) 48 (36.6) 2.56 1.3–5.06 0.002 Contaminated Surgery (groups 48 (34.8) 6 (15) 42 (42.9) 2.85 1.32–6.18 0.002 III-IV*; N = 138) Peritonitis (N = 72) 27 (37.5) 23 (45.1) 4 (19) 2.36 0.93–6.01 0.038 Cancer (N = 38) 12 (31.6) 0 12 (44.4) – – 0.008 SSI (N = 36) 18 (50) 1 (7.7) 17 (73.9) 9.63 1.43–64.15 < 0.001 Revision laparotomy (N = 49) 18 (36.7) 3 (14.3) 15 (53.7) 3.75 1.24–11.29 0.005 Obesity (N = 62) 22 (35.5) 4 (19) 18 (53.3) 2.31 0.894–5.94 0.053 Age; > 70 yr. (N = 85) 20 (23.5) 3 (10) 17 (30.9) 3.09 0.985–9.7 0.03 *World Health Organization wound contamination classification [40], yr years III–IV*) (HR = 2.985 h; 95% CI 1.142–7.8; P = 0.02), SSI The characteristics of the patients in both groups (HR = 3.829; 95% CI 1.86–7.86; P = 0.001), and no use showed small differences. There were more patients in of prophylactic mesh (HR = 5.093 h; 95%CI 2.13–12.17; the M group with a revision laparotomy or with previ- P = 0.001). Table 4. ous midline incision, both of which are well-known risk Hernia-free survival curves showed a clearly higher factors for burst abdomen [12] and IH, and probably, this incidence of IHs in the S group. Median hernia-free circumstance is the explanation for the higher frequency survival was 37 ± 35.96 months in the S group vs. of using a mesh for prevention. This measure was clearly 54 ± 38 months in the M group; P = 0.001 (Fig. 2). effective in revision laparotomy as there was a reduction in the incidence of IHs (14.3% M group vs 53.7% S group; CI: 1.24–11.29; O.R 3.75; P = 0.005). Discussion In our results, almost one third of the diagnosed IHs Emergency laparotomy is frequently associated with appeared after 2 years of follow-up. Therefore, studies worst outcomes in severely ill patients and with a higher with a shorter term would probably underestimate the risk of burst abdomen and IH. As such, prophylactic real incidence of IHs. Our data support similar results measures for these patients are more relevant to prevent obtained in other studies over a long-term follow-up these complications. period for elective patients [20]. Few data are available on long-term outcomes after the Despite the use of mesh reinforcement to prevent IH, use of prophylactic mesh in an emergency setting. To our it seems that IH is delayed but does not disappear com- knowledge, the present study is the first study to ana- pletely as observed in hernia-free survival analysis by the lyze the long-term results of IH prevention with mesh in parallelism of accumulated incidence lines. Hence, the emergency midline laparotomies. One of the strengths of use of a mesh as a prophylaxis seems to act as a “pallia- our study is that the median follow-up time was longer tive” more than a curative measure; therefore, we believe than 5 years in 70% of the cohort. that new closure, prevention techniques, and mesh Table 4 Incisional hernia risk factors in long-term follow up. Multivariate Cox regression B SE Wald (Chi-square) HR 95,0% CI P value Inferior Superior Patient related Smoking 0.904 0.320 7.959 2.468 1.318 4.624 0.05 Surgery related No prophylactic mesh 1.628 0.444 13.421 5.093 2.132 12.167 0.001 Contaminated Surgery 1.094 0.490 4.981 2.985 1.142 7.8 0.02 (groups III-IV*) Complication related Surgical site infection 1.343 0.367 13.375 3.829 1.865 7.864 0.001 *III-IV contaminated stage (contaminated or dirty) according to World Health Organization wound contamination classification [40] Bravo‑Salva et al. BMC Surg (2021) 21:243 Page 6 of 8 Fig. 2 General free hernia COX survival curve materials should be investigated to evaluate their long- subgroups (Table 3) seemed to benefit, and only in obese term outcomes. patients, the incidence of IHs was higher (53.3%) in the When an IH appears despite previous use of a prophy- S group but without reaching statistical significance (OR lactic mesh and needs to be repaired, the risk of recur- 2.31, 0.894–5.94, P = 0.053) probably due to the sample rence seems to be high, in our study where all incisional size. hernia repair in M group patient had a recurrence. The The use of retention sutures had no influence on reduc- presence of a previous mesh could be related to a more ing IHs, and moreover, had a higher incidence of IHs difficult operation, but the small size of the sample pre- when used (39.5%). These results are similar to those cludes to make conclusions. of other studies that evaluated retention sutures [33] In the present study, the number of patients analyzed and strongly supports their discontinuation as a closure was higher than that in our previous analysis [11]. This method. is because in the previous study, some patients had not In our study, the closure of aponeurosis was not per- reached the minimum follow-up for the study inclusion formed using the “small bites” technique as the benefits (1 year), whereas in the present study, those patients were of this technique to reduce IH [34] have not yet been included as they exceeded the follow-up time. published, and moreover, this study was conducted in The use of synthetic mesh in contaminated environ- patients with elective operations. However, some evi- ments, as in emergency laparotomies, is controver- dence has been recently published, and the “small bites” sial [17], but other studies have demonstrated its safety technique also seems to be useful in emergency laparot- in contaminated complex ventral hernia repairs [31]. omy [15, 16]; however, more investigation on this topic is Our results support the view that concerns regarding needed. mesh infections are exaggerated, and the risk of mesh- One of the main warnings against the use of pro- related complications is minimal. This also confirms our phylactic mesh in emergencies is the risk of SSI and previous results on the safety and efficacy of the use of chronic mesh infection as emergency surgical fields synthetic mesh in emergency midline laparotomy rein- are commonly associated with contamination. Fear of forcement, even in the presence of peritonitis [11], thus mesh colonization with its complications have pushed ensuring that mesh reinforcement maintains its capabil- some groups to search for alternatives such as bio- ity to prevent IHs with a minimum rate of complications logical or absorbable meshes in contaminated ventral after a long-term follow-up. hernia repairs [35–38]. In our study, there was low inci- Prophylactic mesh significantly reduces IHs, even dence of such complications, and the capability of mesh when used in high-risk subgroups [32]. All the analyzed prevention was specifically useful in contaminated Bravo‑Salva et al. BMC Surg (2021) 21:243 Page 7 of 8 surgeries and in the presence of postoperative SSI. Both Availability of data and materials The datasets generated and analyzed during the current study are available were independent risk factors for IH after emergency from the corresponding author on reasonable request. midline laparotomies closed with a suture, with a high power of influence (HR 2.98 and 3.82, respectively). Declarations Hence, we believe that the use of prophylactic synthetic onlay mesh reinforcement in high-risk patients, includ- Ethics approval and consent to participate Study protocol and data collection was approved by the Ethical Committee ing those with contaminated surgeries, after the closure CEIC Parc de Salut Mar with number 2019/8240/I. Written patient’s informed of an emergency midline laparotomy is a good preven- consent was obtained for study participation. tion measure due to a simple technique, although it is Consent for publication mandatory to conduct further high-quality studies as Not applicable. prospective or randomized control trials to confirm this. Type of fixation had no differences in IH inci- Competing interests The authors have no conflicts of interest to disclose. dence, however other types of fixation such as fibrin sealants or biologic glues could be interesting to ana- Author details lyze, as had been useful in other studies. [39]. 1 Servicio de Cirugía General Y del Aparato Digestivo, Parc de Salut Mar, Hospital del Mar, P. Marítim 23‑25, 08003 Barcelona, Spain. 2 Departament de The use of a mesh in high-risk patients in elective Ciències, Experimentals I de La Salut, Universitat Pompeu Fabra, Dr. Aiguader midline laparotomies has a strong recommendation 88, 08003 Barcelona, Spain. 3 Departament de Cirurgia, Vall d’Hebrón, Unitat from the EHS guidelines [21] and is a cost-effective Departamental Parc de Salut Mar, Universitat Autónoma de Barcelona, Passeig Vall d’Hebrón 119‑129, 08035 Barcelona, Spain. 4 Departament de Ciències measure [40]. The use of onlay position is effective in Morfològiques, Universitat Autónoma de Barcelona, Campus Bellaterra, preventing IHs and is easy and rapid to perform for a 08193 Cerdanyola del Vallès ‑ Barcelona, Spain. General Surgeon when compared with other mesh Received: 12 January 2021 Accepted: 11 May 2021 insertion planes, such as the retrorectus plane [23], which is known to have a lower complication rate in prophylactic abdominal wall reinforcements [41]. 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