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result(s) for
"Incisional Hernia - epidemiology"
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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
by
Cethorth Fonseca, Roland Kevin
,
Hinojosa Ugarte, Diego
,
Sánchez Téran, Alfonso
in
Abscesses
,
Cellulitis
,
Clinical trials
2024
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.
Journal Article
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
by
Orozco-Mosqueda, A
,
Mayagoitía-González, J C
,
Cano-Rosas, M
in
Clinical trials
,
Hematoma
,
Hernia
2022
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.
Journal Article
Circular stapled end colostomy versus conventional end colostomy creation in patients undergoing a permanent stoma: a randomized controlled trial
2025
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
Journal Article
Long-term results of a prospective randomized trial of midline laparotomy closure with onlay mesh
2019
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.
Journal Article
Does onlay mesh placement in emergency laparotomy prevent incisional hernia? A prospective randomized double-blind study
by
Arslan, K.
,
Eryilmaz, M. A.
,
Simsek, G.
in
Abdomen
,
Abdominal Surgery
,
Abdominal Wound Closure Techniques - adverse effects
2023
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.
Journal Article
Prevention of incisional hernia after kidney transplantation: study protocol for a randomized controlled trial
by
Porrero-Guerrero, Belén
,
Arias-Fúnez, Fernando
,
Burgos-Revilla, Francisco Javier
in
Abdomen
,
Abdominal Wound Closure Techniques - adverse effects
,
Analysis
2023
Background
Incisional hernia is a common complication after kidney transplantation with an incidence of 1.6–18%. Concerning non-transplant patients, a recently published meta-analysis describes a reduction of the incidence of incisional hernia of up to 85% due to prophylactic mesh replacement in elective, midline laparotomy. The aim of our study is to show a reduction of the incidence of incisional hernia after kidney transplantation with minimal risk for complication.
Methods/design
This is a blinded, randomized controlled trial comparing time to incisional hernia over a period of 24 months between patients undergoing kidney transplantation and standardized abdominal closure with or without prophylactic placement of ProGrip™ (Medtronic, Fridley, MN, USA) mesh in an onlay position. As we believe that the mesh intervention is superior to the standard procedure in reducing the incidence of hernia, this is a superiority trial.
Discussion
The high risk for developing incisional hernia following kidney transplantation might be reduced by prophylactic mesh placement. ProGrip™ mesh features polylactic acid (PLA) microgrips that provide immediate, strong and uniform fixation. The use of this mesh combines the effectiveness demonstrated by the macropore propylene meshes in the treatment of incisional hernias, a high simplicity of use provided by its capacity for self-fixation that does not increase significantly surgery time, and safety.
Trial registration
ClinicalTrials.gov NCT04794582. Registered on 08 March 2021. Protocol version 2.0. (02–18-2021).
Journal Article
Impact of non-muscle cutting periumbilical transverse incision on the risk of incisional hernia as compared to midline incision during laparoscopic colon cancer surgery: a study protocol for a multi-centre randomised controlled trial
2023
Background
Minimally invasive surgery has become popular as a surgical approach for colorectal cancer because it has fewer complications related to the abdominal incision and perioperative complications. However, the incidence of incisional hernias in laparoscopic surgery has been reported to be similar to that in open surgery. We developed a new method, the non-muscle-cutting periumbilical transverse incision, for a small incision in laparoscopic colon cancer surgery. This study aims to evaluate the effectiveness of the non-muscle-cutting periumbilical transverse incision in comparison with the midline incision in reducing the incidence of an incisional hernia in patients undergoing laparoscopic colon cancer surgery.
Methods
This is an open-label, multi-centre, parallel, superiority, and randomised trial. Altogether, 174 patients will be allocated in a 1:1 ratio to either the midline incision or the non-muscle-cutting periumbilical transverse incision group, after stratifying by the location of the tumour (right- or left-sided). The primary outcome of this study is the incidence of incisional hernias (both symptomatic and radiologic hernias) at 12 months after surgery. The secondary outcomes include operative outcomes, 30-day postoperative complications, pathological results, and patient-reported outcomes (short form-12 health survey questionnaire and body image questionnaire). Both primary (intention-to-treat) and secondary (as-treated principles) analyses will be performed for all outcomes. The statistical significance level was set at
p
< 0.05 (two-sided testing).
Discussion
This trial may show that the non-muscle-cutting periumbilical transverse incision will reduce the incidence of incisional hernias compared to the midline incision.
Trial registration
Clinical Research Information Service (CRiS) of Republic of Korea,
KCT0006082
. Registered on April 12, 2021.
Journal Article
A Cost-Utility Analysis of Mesh Prophylaxis in the Prevention of Incisional Hernias following Stoma Closure Surgery
by
Sheikh, Yusuf
,
de Preux, Laure
,
Muthukumar, Keerthi
in
Clinical outcomes
,
Cost-Benefit Analysis
,
Costs
2022
Background: Stoma closure is a widely performed surgical procedure, with 6295 undertaken in England in 2018 alone. This procedure is associated with significant complications; incisional hernias are the most severe, occurring in 30% of patients. Complications place considerable financial burden on the NHS; hernia costs are estimated at GBP 114 million annually. As recent evidence (ROCSS, 2020) found that prophylactic meshes significantly reduce rates of incisional hernias following stoma closure surgery, an evaluation of this intervention vs. standard procedure is essential. Methods: A cost-utility analysis (CUA) was conducted using data from the ROCSS prospective multi-centre trial, which followed 790 patients, randomly assigned to mesh closure (n = 394) and standard closure (n = 396). Quality of life was assessed using mean EQ-5D-3L scores from the trial, and costs in GBP using UK-based sources over a 2-year time horizon. Results: The CUA yielded an incremental cost-effectiveness ratio (ICER) of GBP 128,356.25 per QALY. Additionally, three univariate sensitivity analyses were performed to test the robustness of the model. Conclusion: The results demonstrate an increased benefit with mesh prophylaxis, but at an increased cost. Although the intervention is cost-ineffective and greater than the ICER threshold of GBP 30,000/QALY (NICE), further investigation into mesh prophylaxis for at risk population groups is needed.
Journal Article
Superiority trial for the development of an ideal method for the closure of midline abdominal wall incisions to reduce the incidence of wound complications after elective gastroenterological surgery: study protocol for a randomized controlled trial
by
Hiroshi Noda
,
Natsumi Matsuzawa
,
Yuji Takayama
in
Abdomen
,
Abdominal Wall - surgery
,
Abdominal Wound Closure Techniques - adverse effects
2024
Background
The recent guidelines from the European and American Hernia Societies recommend a continuous small-bite suturing technique with slowly absorbable sutures for fascial closure of midline abdominal wall incisions to reduce the incidence of wound complications, especially for incisional hernia. However, this is based on low-certainty evidence. We could not find any recommendations for skin closure. The wound closure technique is an important determinant of the risk of wound complications, and a comprehensive approach to prevent wound complications should be developed.
Methods
We propose a single-institute, prospective, randomized, blinded-endpoint trial to assess the superiority of the combination of continuous suturing of the fascia without peritoneal closure and continuous suturing of the subcuticular tissue (study group) over that of interrupted suturing of the fascia together with the peritoneum and interrupted suturing of the subcuticular tissue (control group) for reducing the incidence of midline abdominal wall incision wound complications after elective gastroenterological surgery with a clean-contaminated wound. Permuted-block randomization with an allocation ratio of 1:1 and blocking will be used. We hypothesize that the study group will show a 50% reduction in the incidence of wound complications. The target number of cases is set at 284. The primary outcome is the incidence of wound complications, including incisional surgical site infection, hemorrhage, seroma, wound dehiscence within 30 days after surgery, and incisional hernia at approximately 1 year after surgery.
Discussion
This trial will provide initial evidence on the ideal combination of fascial and skin closure for midline abdominal wall incision to reduce the incidence of overall postoperative wound complications after gastroenterological surgery with a clean-contaminated wound. This trial is expected to generate high-quality evidence that supports the current guidelines for the closure of abdominal wall incisions from the European and American Hernia Societies and to contribute to their next updates.
Trial registration
UMIN-CTR UMIN000048442. Registered on 1 August 2022.
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055205
Journal Article
Randomized controlled trial comparing cosmetic results of midline incision versus off-midline incision for specimen extraction in laparoscopic colectomy
by
Iwamoto, Hiromitsu
,
Matsuda, Kenji
,
Mitani, Yasuyuki
in
Abdomen
,
Clinical trials
,
Colorectal cancer
2023
PurposeA notable advantage of laparoscopic colorectal surgery is that only a small incision at the extraction site is necessary, which is considered to be cosmetically beneficial. Meanwhile, the optimal extraction site for the resected specimen in laparoscopic colectomy is controversial in terms of cosmetic benefit. This randomized controlled trial compares midline and off-midline extraction sites in laparoscopic colectomy in patients with colon cancer, with consideration of cosmetic benefits as the primary endpoint.MethodsIncluded were patients that underwent elective laparoscopic colectomy at WMUH between October 2014 and February 2017. Patients were randomly assigned to either midline incision group or off-midline incision group. Prospectively collected data included cosmetic results (patients and observer assessment scale) and complications including incidence of incisional hernia, SSI, and pain. This trial was registered with UMIN Clinical Trials (UMIN000028943).ResultsFinally, 98 patients with colorectal cancer were analyzed. No significant differences were found between the two groups in patient and observer assessment scales of cosmetic results (midline 8 ± 1.1 vs off-midline 11 ± 5.9 p = 0.16, midline 13.5 ± 6.6 vs off-midline 15 ± 11 p = 0.58, respectively) or in postoperative pain. However, incisional hernia occurred in four cases in the midline group (8%), which was significantly higher than that in the off-midline group (no cases, 0%).ConclusionThere was no significant difference in terms of cosmetic benefit, the primary endpoint, between the two groups. In this study, only the extraction site location was compared; future studies will examine differences depending on the incisional direction, including the incidence of incisional hernia.
Journal Article