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1,485 result(s) for "Incisional hernia"
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Surgical site occurrence after prophylactic use of mesh for prevention of incisional hernia in midline laparotomy: systematic review and meta-analysis of randomized clinical trials
BackgroundThe use of mesh is the standard for the prevention of incisional hernia (IH). However, the effect of surgical site occurrence (SSO) has never been compared. The aim of this meta-analysis was to evaluate the prevalence of SSO and measure its negative effect through the calculation of the number needed to treat for net effect (NNT net).MethodsA meta-analysis was performed according to the PRISMA guidelines. The primary objective was to determine the prevalence of SSO and IH, and the secondary objective was to determine the NNT net as a metric to measure the combined benefits and harms. Only published clinical trials were included. The risk of bias was analyzed, and the random effects model was used to determine statistical significance.ResultsA total of 15 studies comparing 2344 patients were included. The incidence of IH was significantly lower in the mesh group than in the control group, with an OR of 0.29 (95% CI 0.16–0.49, p = 0.0001). The incidence of SSO was higher in the mesh group than in the control group, with an OR of 1.21 (95% CI 0.85–1.72, p = 0.0001) but without statistical significance. Therefore, the way to compare the benefits and risks of each of the studies was done with the calculation of the NNT net, which is the average number of patients who need to be treated to see the benefit exceeding the harm by one event, and the result was 5, which is the average number of patients who need to be treated to see the benefit exceeding the harm by one event.ConclusionThe use of mesh reduces the prevalence of IH and it does not increases the prevalence of SSO, the NNT net determined that the use of mesh continues to be beneficial for the patient.
Prevention of incisional hernia with a reinforced tension line (RTL) versus primary suture only in midline laparotomies: 3-year follow-up in a randomized clinical trial
PurposeIncisional hernia (IH) has an incidence of 10–23%, which can increase to 38% in specific risk groups. The objective of this study is to report the results at 3 years of follow-up of the use of the reinforced tension line (RTL) technique compared with primary suture only (PSO) closure in the prevention of IH in high-risk patients undergoing laparotomy. MethodsOpen randomized controlled clinical trial. Included were patients older than 18 years who underwent midline laparotomy, emergency or scheduled, who were considered high risk, and who completed 3-year follow-up. The patients were randomized 1:1 to the RTL technique or to PSO. The objective was to report the incidence of IH and the complications associated with the closure method. Intention-to-treat analysis and Cox regression were performed. ResultsA total of 124 patients were randomized; 51 patients from the RTL group and 53 patients from the PSO group finished the 3-year follow-up. The incidence of IH was higher in the PSO group (15/53, 28.3%) than the RTL group (5/51, 9.8%) (p = 0.016, OR 0.35, 95% CI 0.14–0.88, number needed to treat 5.4, log-rank test p = 0.017). The groups were similar in the rates of surgical site infection, hematoma, seroma, and postoperative pain during follow-up.ConclusionsThe RTL technique is useful in the prevention of IH when compared with PSO in high-risk midline laparotomy patients, and it is not associated with a higher percentage of complications.Trial registrationLocal Committee CI-HRAEB-2013-020. March 13, 2013.Clinical trialsNCT02136628, retrospectively registered.
Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy—Long-Term Results of a Randomized Controlled Trial
Objectives Incisional hernia, a serious complication after laparotomy, is associated with high morbidity and costs. This trial examines the value of prophylactic intraperitoneal onlay mesh to reduce the risk of incisional hernia after a median follow-up time of 5.3 years. Methods We conducted a parallel group, open-label, single center, randomized controlled trial (NCT01003067). After midline incision, the participants were either allocated to abdominal wall closure according to Everett with a PDS-loop running suture reinforced by an intraperitoneal composite mesh strip (Group A ) or the same procedure without the additional mesh strip (Group B ). Results A total of 276 patients were randomized (Group A  = 131; Group B  = 136). Follow-up data after a median of 5.3 years after surgery were available from 183 patients (Group A  = 95; Group B  = 88). Incisional hernia was diagnosed in 25/95 (26%) patients in Group A and in 46/88 (52%) patients in Group B (risk ratio 0.52; 95% CI 0.36–0.77; p  < 0.001). Eighteen patients with asymptomatic incisional hernia went for watchful waiting instead of hernia repair and remained free of symptoms after of a median follow-up of 5.1 years. Between the second- and fifth-year follow-up period, no complication associated with the mesh could be detected. Conclusion The use of a composite mesh in intraperitoneal onlay position significantly reduces the risk of incisional hernia during a 5-year follow-up period. Trial registration number Ref. NCT01003067 (clinicaltrials.gov).
Patient reported outcomes after incisional hernia repair—establishing the ventral hernia recurrence inventory
Assessing incisional hernia recurrence typically requires a clinical encounter. We sought to determine if patient-reported outcomes (PROs) could detect long-term recurrence. Adult patients 1 to 5 years after incisional hernia repair were prospectively asked about recurrence, bulge, and pain at the original repair site. Using dynamic abdominal sonography for hernia to detect recurrence, performance of each PRO was determined. Multivariable regression was used to evaluate PRO association with recurrence. Fifty-two patients enrolled with follow-up time 46 ± 13 months. A patient-reported bulge was 85% sensitive, and 81% specific to detect recurrence. Patients reporting no bulge and no pain had 0% chance of recurrence. In multivariable analysis, patients reporting a bulge were 18 times more likely to have a recurrence than those without (95% confidence interval, 3.7 to 90.0; P < .001). This preliminary study demonstrates that PROs offer a promising means of detecting long-term recurrence after incisional hernia repair, which can help facilitate quality improvement and research efforts. [Display omitted] •The performance of PROs for detecting incisional hernia recurrence was evaluated.•Patient-reported bulge is 85% sensitive, and 81% specific for detecting recurrence.•PROs can facilitate long-term follow-up after incisional hernia repair.
Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind, randomised controlled trial
Incisional hernia is a frequent long-term complication after abdominal surgery, with a prevalence greater than 30% in high-risk groups. The aim of the PRIMA trial was to evaluate the effectiveness of mesh reinforcement in high-risk patients, to prevent incisional hernia. We did a multicentre, double-blind, randomised controlled trial at 11 hospitals in Austria, Germany, and the Netherlands. We included patients aged 18 years or older who were undergoing elective midline laparotomy and had either an abdominal aortic aneurysm or a body-mass index (BMI) of 27 kg/m2 or higher. We randomly assigned participants using a computer-generated randomisation sequence to one of three treatment groups: primary suture; onlay mesh reinforcement; or sublay mesh reinforcement. The primary endpoint was incidence of incisional hernia during 2 years of follow-up, analysed by intention to treat. Adjusted odds ratios (ORs) were estimated by logistic regression. This trial is registered at ClinicalTrials.gov, number NCT00761475. Between March, 2009, and December, 2012, 498 patients were enrolled to the study, of whom 18 were excluded before randomisation. Therefore, we included 480 patients in the primary analysis: 107 were assigned primary suture only, 188 were allocated onlay mesh reinforcement, and 185 were assigned sublay mesh reinforcement. 92 patients were identified with an incisional hernia, 33 (30%) who were allocated primary suture only, 25 (13%) who were assigned onlay mesh reinforcement, and 34 (18%) who were assigned sublay mesh reinforcement (onlay mesh reinforcement vs primary suture, OR 0·37, 95% CI 0·20–0·69; p=0·0016; sublay mesh reinforcement vs primary suture, 0·55, 0·30–1·00; p=0·05). Seromas were more frequent in patients allocated onlay mesh reinforcement (34 of 188) than in those assigned primary suture (five of 107; p=0·002) or sublay mesh reinforcement (13 of 185; p=0·002). The incidence of wound infection did not differ between treatment groups (14 of 107 primary suture; 25 of 188 onlay mesh reinforcement; and 19 of 185 sublay mesh reinforcement). A significant reduction in incidence of incisional hernia was achieved with onlay mesh reinforcement compared with sublay mesh reinforcement and primary suture only. Onlay mesh reinforcement has the potential to become the standard treatment for high-risk patients undergoing midline laparotomy. Baxter; B Braun Surgical SA.
Parastomal Hernia: A Retrospective Nationwide Cohort Study Comparing Different Techniques with Long-Term Follow-Up
Background Parastomal hernia repair is a complex surgical procedure with high recurrence and complication rates. This retrospective nationwide cohort study presents the results of different parastomal hernia repair techniques in Finland. Methods All patients who underwent a primary end ostomy parastomal hernia repair in the nine participating hospitals during 2007–2017 were included in the study. The primary outcome measure was recurrence rate. Secondary outcomes were complications and re-operation rate. Results In total, 235 primary elective parastomal hernia repairs were performed in five university hospitals and four central hospitals in Finland during 2007–2017. The major techniques used were the Sugarbaker (38.8%), keyhole (16.3%), and sandwich techniques (15.4%). In addition, a specific intra-abdominal keyhole technique with a funnel-shaped mesh was utilized in 8.3% of the techniques; other parastomal hernia repair techniques were used in 21.3% of the cases. The median follow-up time was 39.0 months (0–146, SD 35.3). The recurrence rates after the keyhole, Sugarbaker, sandwich, specific funnel-shaped mesh, and other techniques were 35.9%, 21.5%, 13.5%, 15%, and 35.3%, respectively. The overall re-operation rate was 20.4%, while complications occurred in 26.3% of patients. Conclusion The recurrence rate after parastomal hernia repair is unacceptable in this nationwide cohort study. As PSH repair volumes are low, further multinational, randomized controlled trials and hernia registry data are needed to improve the results.
Circular stapled end colostomy versus conventional end colostomy creation in patients undergoing a permanent stoma: a randomized controlled trial
Background Parastomal herniation is a prevalent complication of colostomies, with rates as high as 60% at 2 years. Traditional methods, including mesh use, have shown limited success. Here, we aim to compare 1-year PSH rates and evaluate stoma-related complications using a stapled versus conventional approach. Methods This randomized controlled trial investigates the efficacy of using a circular stapler to create an end colostomy for reducing parastomal hernia (PSH) incidence compared to conventional techniques. Eligible patients (aged 18–70) undergoing end colostomy for rectal cancer at Tata Memorial Hospital will be randomized into two groups: circular stapled versus conventional cruciate incision. Primary outcomes will be 1-year PSH rates, determined clinically and radiologically, with secondary outcomes including short-term stoma-related complications and reoperation rates. Discussion The study’s findings will provide evidence on the circular stapler’s effectiveness in reducing PSH incidence, potentially offering an innovative approach to ostomy creation. If successful, this technique may improve patient outcomes and reduce long-term healthcare costs related to PSH management. Trial registration CTRI/2023/10/059362; protocol version 1.2. Registered on March 11, 2023
Does onlay mesh placement in emergency laparotomy prevent incisional hernia? A prospective randomized double-blind study
Purpose The objective of this study is to assess the effectiveness and safety of onlay mesh closure of emergency midline laparotomy to prevent incisional hernia. Methods This is a prospective randomized double-blind study and was carried out in the General Surgery Clinic, Konya City Hospital, from August 1, 2020 to August, 1, 2021. The study included 108 patients who were randomly grouped in 2 groups: patients with conventional abdominal closure and closure using additional onlay mesh (1:1). The follow-up period was for a year. The primary outcome was the incidence of incisional hernia and secondary outcomes were clinical data like complications, hospital length of stay, re-operations. Results It was observed that incisional hernia was present in 14 patients (27.4%) in conventional abdominal closure group and was in 2 patients using mesh (4%), ( p  = 0.001). Clavien–Dindo 3B complications were in rise in conventional closure group ( p  = 0.02). Of all complications, burst abdomen was significantly more common in conventional closure group ( p  = 0.04). The rate of surgically treated complications were higher in conventional closure group ( p  = 0.02). Clavien–Dindo 3A complications were more common in patients with contaminated wound in mesh group ( p  = 0.02). Conclusion The use of mesh while closing the abdomen in emergency midline laparotomy reduces the risk of incisional hernia. Thus, to lower the risks of incisional hernia and its complications, prophylactic mesh can be used in high-risk patients.
Long-term results of a prospective randomized trial of midline laparotomy closure with onlay mesh
PurposeIncisional hernia (IH) continues to be one of the most common complications of laparotomy. The short-term protective effect of the use of mesh has been demonstrated in several studies. At present, there is little evidence on the long-term results of the prophylactic use of mesh. The aim of the present study is to analyze the long-term prevention of IH 5 years after a midline laparotomy during elective surgery.MethodsA prospective study was performed including all of the 160 patients that had been previously included in the prospective, randomized, controlled trial performed between May 2009 and November 2012. The protocol and results at 1 year have been previously published in 2014. The patients in group A (mesh) were fitted with a polypropylene mesh to reinforce the standard abdominal wall closure. The patients in group B (non-mesh) underwent a standard abdominal wall closure and were not fitted with the mesh. All patients were followed for 5 years or until the diagnosis of incisional hernia was made, further surgery was performed, or the patient died. Cases lost to follow-up were also registered.ResultsFive years after surgery, in group A (mesh) we have found 4/80 (5.1%) incisional hernias, while in group B (no mesh) 37/80 patients were diagnosed with an incisional hernia (46.8%). The Kaplan–Meier survival curves for these results show statistically significant differences (p > 0.001).ConclusionThe protective effect of the use of an onlay mesh in abdominal wall closure is significantly maintained in the long-term, up to 5 years after surgery.International Standard Randomized Controlled Trial number: ISRCTN98336745.
Long-term follow-up of full-thickness skin grafting in giant incisional hernia repair: a randomised controlled trial
PurposeConventional repair of a giant incisional hernia often requires implantation of a synthetic mesh (SM). However, this surgical procedure can lead to discomfort, pain, and potentially serious complications. Full-thickness skin grafting (FTSG) could offer an alternative to SM, less prone to complications related to implantation of a foreign body in the abdominal wall. The aim of this study was to compare the use of FTSG to conventional SM in the repair of giant incisional hernia.MethodsPatients with a giant incisional hernia (> 10 cm width) were randomised to repair with either FTSG or SM. 3-month and 1-year follow-ups have already been reported. A clinical follow-up was performed 3 years after repair, assessing potential complications and recurrence. SF-36, EQ-5D and VHPQ questionnaires were answered at 3 years and an average of 9 years (long-term follow-up) after surgery to assess the impact of the intervention on quality-of-life (QoL).ResultsFifty-two patients were included. Five recurrences in the FTSG group and three in the SM group were noted at the clinical follow-up 3 years after surgery, but the difference was not significant (p = 0.313). No new procedure-related complication had occurred since the one-year follow-up. There were no relevant differences in QoL between the groups. However, there were significant improvemnts in both physical, emotional, and mental domains of the SF-36 questionnaire in both groups.ConclusionThe results of this long-term follow-up together with the results from previous follow-ups indicate that autologous FTSG as reinforcement in giant incisional hernia repair is an alternative to conventional repair with SM.Trial RegistrationThe study was registered August 10, 2011 at ClinicalTrials.gov (ID NCT01413412), retrospectively registered.