Prophylactic, Synthetic Intraperitoneal Mesh Versus No Mesh Implantation in Patients with Fascial Dehiscence.
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ABSTRACT: Background
Primary closure of post-operative facial dehiscence (FD) is associated with a high incidence of recurrence, revisional surgery, and incisional hernia. This retrospective study compares outcomes of implantation of non-absorbable intra-abdominal meshes with primary closure of FD. The outcomes of different mesh materials were assessed in subgroup analysis.Methods
A total of 119 consecutive patients with FD were operated (70 mesh group and 49 no mesh group) between 2001 and 2015. Primary outcome parameter was hernia-free survival. Secondary outcome parameters include re-operations of the abdominal wall, intestinal fistula, surgical site infections (SSI), and mortality. Kaplan-Meier analysis for hernia-free survival, adjusted Poisson regression analysis for re-operations and adjusted regression analysis for chronic SSI was performed.Results
Hernia-free survival was significantly higher in the mesh group compared to the no mesh group (P = 0.005). Fewer re-operations were necessary in the mesh group compared to the no mesh group (adjusted incidence risk ratio 0.44, 95% confidence interval [CI] 0.20-0.93, P = 0.032). No difference in SSI, intestinal fistula, and mortality was observed between groups. Chronic SSI was observed in 7 (10%) patients in the mesh group (n = 3 [6.7%] with polypropylene mesh and 4 [28.6%] with polyester mesh). The risk for chronic SSI was significantly higher if a polyester mesh was used when compared to a polypropylene mesh (adjusted odds ratio 8.69, 95% CI 1.30-58.05, P = 0.026).Conclusion
Implantation of a polypropylene but not polyester-based mesh in patients with FD decreases incisional hernia with a low rate of mesh-related morbidity.
SUBMITTER: Jakob MO
PROVIDER: S-EPMC6244924 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ImportanceIncisional hernia is a frequent complication after open abdominal surgery. Prophylactic mesh implantation in the onlay or sublay position requires dissection of the abdominal wall, potentially leading to wound-associated complications.ObjectiveTo compare the incidence of incisional hernia among patients after prophylactic intraperitoneal mesh implantation with that among patients after standard abdominal closure.Design, setting, and participantsAn open-label randomized clinical trial was performed in 169 patients undergoing elective open abdominal surgery from January 1, 2011, to February 29, 2014. Follow-up examinations were performed 1 year and 3 years after surgery. The study was conducted at Bern University Hospital, Bern, Switzerland, a referral center that offers the whole spectrum of abdominal surgical interventions. Patients with 2 or more of the following risk factors were included: overweight or obesity, diagnosis of neoplastic disease, male sex, or history of previous laparotomy. Patients were randomly assigned to prophylactic intraperitoneal mesh implantation or standard abdominal closure. Data were analyzed in August 2017.InterventionsIntraperitoneal implantation of a polypropylene-polyvinylidene fluoride mesh with circumferential fixation.Main outcomes and measuresThe primary end point was the incidence of incisional hernia 3 years after surgery. Secondary end points included mesh-related complications.ResultsAfter the exclusion of 19 patients, 150 patients (81 in the control group and 69 in the mesh group; mean [SD] age, 64.2 [11.1] years; 102 [68.0%] male) were studied. The cumulative incidence of incisional hernia was significantly lower in the mesh group compared with the control group (5 of 69 [7.2%] vs 15 of 81 [18.5%], log-rank test P = .03). Abdominal pain was observed in significantly more patients in the mesh group compared with the control group at 6 weeks (34 of 52 [65%] vs 26 of 59 [44%], P = .04) but not at 12 and 36 months postoperatively. No difference in surgical site infections was observed, but time to complete wound healing of surgical site infection was significantly longer in patients with mesh implantation (median [interquartile range], 8 [6-24] weeks compared with 5 [1-9] weeks; P = .03). Trunk extension was significantly decreased after mesh implantation compared with the control group (mean [SD], 1.73 [0.97] cm vs 2.40 [1.23] cm, P = .009).Conclusions and relevanceIn patients at elevated risk for incisional hernia, prophylactic intraperitoneal mesh implantation reduces the incidence of hernia formation but with increased early postoperative pain and prolonged wound healing of surgical site infection.Trial registrationClinicalTrials.gov Identifier: NCT01203553.
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Project description:BackgroundFascial dehiscence (FD) and incisional hernia (IH) pose considerable risks to patients who undergo abdominal surgery, and many preventive strategies have been applied to reduce this risk. An accurate predictive model could aid identification of high-risk patients, who could be targeted for particular care. This study aims to systematically review existing FD and IH prediction models.MethodsPrediction models were identified using pre-specified search terms on SCOPUS, PubMed, and Web of Science. Eligible studies included those conducted in adult patients who underwent any kind of abdominal surgery, and reported model performance. Data from the eligible studies were extracted, and the risk of bias (RoB) was assessed using the PROBAST tool. Pooling of C-statistics was performed using a random-effect meta-analysis. [Registration: PROSPERO (CRD42021282463)].ResultsTwelve studies were eligible for review; five were FD prediction model studies. Most included studies had high RoB, especially in the analysis domain. The C-statistics of the FD and IH prediction models ranged from 0.69 to 0.92, but most have yet to be externally validated. Pooled C-statistics (95% CI) were 0.80 (0.74, 0.86) and 0.81 (0.75, 0.86) for the FD (external-validation) and IH prediction model, respectively. Some predictive factors such as body mass index, smoking, emergency operation, and surgical site infection were associated with FD or IH occurrence and were included in multiple models.ConclusionsSeveral models have been developed as an aid for FD and IH prediction, mostly with modest performance and lacking independent validation. New models for specific patient groups may offer clinical utility.
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Project description:BackgroundClosure of an abdominal stoma, a common elective operation, is associated with frequent complications; one of the commonest and impactful is incisional hernia formation. We aimed to investigate whether biological mesh (collagen tissue matrix) can safely reduce the incidence of incisional hernias at the stoma closure site.MethodsIn this randomised controlled trial (ROCSS) done in 37 hospitals across three European countries (35 UK, one Denmark, one Netherlands), patients aged 18 years or older undergoing elective ileostomy or colostomy closure were randomly assigned using a computer-based algorithm in a 1:1 ratio to either biological mesh reinforcement or closure with sutures alone (control). Training in the novel technique was standardised across hospitals. Patients and outcome assessors were masked to treatment allocation. The primary outcome measure was occurrence of clinically detectable hernia 2 years after randomisation (intention to treat). A sample size of 790 patients was required to identify a 40% reduction (25% to 15%), with 90% power (15% drop-out rate). This study is registered with ClinicalTrials.gov, NCT02238964.FindingsBetween Nov 28, 2012, and Nov 11, 2015, of 1286 screened patients, 790 were randomly assigned. 394 (50%) patients were randomly assigned to mesh closure and 396 (50%) to standard closure. In the mesh group, 373 (95%) of 394 patients successfully received mesh and in the control group, three patients received mesh. The clinically detectable hernia rate, the primary outcome, at 2 years was 12% (39 of 323) in the mesh group and 20% (64 of 327) in the control group (adjusted relative risk [RR] 0·62, 95% CI 0·43-0·90; p=0·012). In 455 patients for whom 1 year postoperative CT scans were available, there was a lower radiologically defined hernia rate in mesh versus control groups (20 [9%] of 229 vs 47 [21%] of 226, adjusted RR 0·42, 95% CI 0·26-0·69; p<0·001). There was also a reduction in symptomatic hernia (16%, 52 of 329 vs 19%, 64 of 331; adjusted relative risk 0·83, 0·60-1·16; p=0·29) and surgical reintervention (12%, 42 of 344 vs 16%, 54 of 346: adjusted relative risk 0·78, 0·54-1·13; p=0·19) at 2 years, but this result did not reach statistical significance. No significant differences were seen in wound infection rate, seroma rate, quality of life, pain scores, or serious adverse events.InterpretationReinforcement of the abdominal wall with a biological mesh at the time of stoma closure reduced clinically detectable incisional hernia within 24 months of surgery and with an acceptable safety profile. The results of this study support the use of biological mesh in stoma closure site reinforcement to reduce the early formation of incisional hernias.FundingNational Institute for Health Research Research for Patient Benefit and Allergan.
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Project description:Introduction: Several different temporary abdominal closure techniques are described in the context of open abdomen treatment. Techniques based on dynamic fascial closure combined with negative pressure therapy have gained popularity and seem to result in the highest fascial closure rates without increased complications and are highlighted in recent guidelines and recommendations. One dynamic closure technique is the vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM) technique, first described in 2007. The aim of this systematic review was to evaluate the VAWCM technique regarding a number of short- and long-term results. Materials and Methods: A systematic literature search was performed in PubMed, EMBASE, and Cochrane Library databases for articles published between January 1, 2006 and May 8, 2020. The review was independently performed by the two authors according to the PRISMA statements for reporting systematic reviews and meta-analyses. Results were pooled for presentation of weighted means when applicable. Results: A total of 220 articles were screened by title and abstract. Thirty-two articles were assessed for eligibility by full-text review and 15 articles finally remained for review. A total of 600 patients treated with VAWCM were included. The pooled weighted means were as follows: fascial closure, 83.5%; enteroatmospheric fistula, 5.6%; planned ventral hernia, 6.2%; in-hospital survival, 72%; and incisional hernia incidence, 40.5%. Long-term survival ranged between 22 and 72%. Quality of life (SF-36) was reported in two studies showing lower scores than the population mean especially in physical domains. Incisional hernia resulted in lower scores in one but not in the other study. Discussion: The results of 600 VAWCM-treated patients from 15 studies were evaluated in this systematic review. Earlier findings with high fascial closure rates, low enteroatmospheric fistula, and planned ventral hernia rates as well as high incisional hernia incidences were underlined. Permanent mesh for efficient fascial traction and reinforcement at fascial closure seem to be the next step in evolving an optimal temporary closure technique in open abdomen treatment.
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Project description:Various materials and approaches have been used to optimize the biocompatibility of mesh to reduce the implant-induced host response in intraperitoneal onlay mesh (IPOM) repair. Ineffective host integration, limited resistance to contamination, and untargeted administration hinder the wider application of the currently available clinical options. In this study, human amniotic membrane (HAM) was decellularized, fully characterized, and compared with porcine small intestinal submucosa (SIS) in terms of its structure, components, and bioactivity. In an in vivo study, HAM was reinforced with silk fibroin (SF) membrane, which was fabricated as a biodegradable submicroscale template by electrospinning, to construct a bilayer composite mesh. The independent SF membrane, associated with HAM and SIS, was evaluated for tissue remodeling in vitro. The HAM-SF and SIS meshes were then characterized morphologically and implanted intraperitoneally into Sprague-Dawley rats for 28 days for macroscopic investigation of their integration into the host via interactions of regulatory factors. After decellularization, HAM formed a bioagent-rich collagen-based acellular structure. HAM was superior to SIS in concurrently suppressing the expression of transforming growth factor ?1 (TGF-?1) and proangiogenic proliferation. When HAM, SF, and SIS were used as regenerative scaffolds, they showed qualified biocompatibility, cell infiltration, and degradation in vitro. Comparatively, macroscopic observation after implantation indicated that HAM-SF induced less-intensive intraperitoneal adhesion and weaker inflammatory responses at the interface but greater angiogenesis in the explant than SIS. Analysis of the expression of regulatory factors showed a greater quantity of hepatocyte growth factor (HGF) in HAM, which partly inhibited the expression of TGF-?1 and promoted vascular endothelial growth factor (VEGF)-induced angiogenesis. This bioactive interaction appeared to be responsible for the better host integration, making HAM more biocompatible than SIS in IPOM repair. When combined with SF, HAM displayed similar mechanical properties to SIS. In conclusion, HAM displayed better bioactivity and biocompatibility than SIS. After its reinforcement with SF, HAM-SF is a promising biocomposite mesh for IPOM repair.
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