Mesh versus non-mesh for emergency groin hernia repair.
A groin hernia is a collective name for inguinal and femoral hernias, which can present acutely with incarceration or strangulation of the hernia sac content, requiring emergency treatment. Timely repair of emergency groin hernias is crucial due to the risk of reduced blood supply and thus damage to the bowel, but the optimal surgical approach is unclear. While mesh repair is the standard treatment for elective hernia surgery, using mesh for emergency groin hernia repair remains controversial due to the risk of surgical site infection.
To assess the benefits and harms of mesh compared with non-mesh in emergency groin hernia repair in adult patients with an inguinal or femoral hernia.
On 5 August 2022, we searched the following databases: CENTRAL, MEDLINE Ovid, and Embase Ovid, as well as two trial registers for ongoing and completed trials. Additionally, we performed forward and backward citation searches for the included trials and relevant review articles. We searched without any language or publication restrictions.
We included randomised controlled trials (RCTs) comparing mesh with non-mesh repair in emergency groin hernia surgery in adults. We included any mesh and any non-mesh repairs. All studies fulfilling the study, participant, and intervention criteria were included irrespective of reported outcomes.
We used standard Cochrane methodology. We presented dichotomous data as risk ratios (RR) with 95% confidence intervals (CI). We based missing data analysis on best- and worst-case scenarios. For outcomes with sufficiently low heterogeneity, we performed meta-analyses using the random-effects model. We analysed subgroups when feasible, including the degree of contamination. We used RoB 2 for risk of bias assessment, and summarised the certainty of evidence using GRADE.
We included 15 trials randomising 1241 participants undergoing emergency groin hernia surgery with either mesh (626 participants) or non-mesh hernia repair (615 participants). The studies were conducted in China, the Middle East, and South Asia. Most patients were men, and most participants had an inguinal hernia (41 participants had femoral hernias). The mean/median age in the mesh group ranged from 35 to 70 years, and from 41 to 69 years in the non-mesh group. All studies were performed in a hospital emergency setting (tertiary care) and lasted for 11 to 139 months, with a median study duration of 31 months. The majority of the studies only included participants with clean to clean-contaminated surgical fields. For all outcomes, we considered the certainty of the evidence to be very low, mainly downgraded due to high risk of bias (due to deviations from intended intervention and missing outcome data), indirectness, and imprecision. Mesh hernia repair may have no effect on or slightly increase the risk of 30-day surgical site infections (RR 1.66, 95% CI 0.96 to 2.88; I² = 21%; 2 studies, 454 participants) when compared with non-mesh hernia repair, but the evidence is very uncertain. The evidence is also very uncertain about the effect of mesh hernia repair compared with non-mesh hernia repair on 30-day mortality (RR 1.38, 95% CI 0.58 to 3.28; 1 study, 208 participants). In summary, the results showed 70 more (from 5 fewer to 200 more) surgical site infections and 29 more (from 32 fewer to 175 more) deaths within 30 days of mesh hernia repair per 1000 participants compared with non-mesh hernia repair. The evidence is very uncertain about 90-day surgical site infections after mesh versus non-mesh hernia repair (RR 1.00, 95% CI 0.15 to 6.64; 1 study, 60 participants; very low-certainty evidence). No 30-day recurrences were recorded, and mesh hernia repair may not reduce recurrence within one year (RR 0.19, 95% CI 0.04 to 1.03; I² = 0%; 2 studies, 104 participants; very low-certainty evidence). Within 30 days of hernia repair, no meshes were removed from clean to clean-contaminated fields, but 6.7% of meshes (1 study, 208 participants) were removed from contaminated to dirty surgical fields. Among the four studies reporting 90-day mesh removal, no events occurred. We were not able to identify any studies reporting complications classified according to the Clavien-Dindo Classification or reoperation for complications within 30 days of repair.
Our results show that in terms of 30-day surgical site infections, 30-day mortality, and hernia recurrence within one year, the evidence for the use of mesh hernia repair compared with non-mesh hernia repair in emergency groin hernia surgery is very uncertain. Unfortunately, firm conclusions cannot be drawn due to very low-certainty evidence and meta-analyses based on small-sized and low-quality studies. There is a need for future high-quality RCTs or high-quality registry-based studies if RCTs are unfeasible.
Sæter AH
，Fonnes S
，Li S
，Rosenberg J
，Andresen K
... -
《Cochrane Database of Systematic Reviews》
Comparison of Two Modern Survival Prediction Tools, SORG-MLA and METSSS, in Patients With Symptomatic Long-bone Metastases Who Underwent Local Treatment With Surgery Followed by Radiotherapy and With Radiotherapy Alone.
Survival estimation for patients with symptomatic skeletal metastases ideally should be made before a type of local treatment has already been determined. Currently available survival prediction tools, however, were generated using data from patients treated either operatively or with local radiation alone, raising concerns about whether they would generalize well to all patients presenting for assessment. The Skeletal Oncology Research Group machine-learning algorithm (SORG-MLA), trained with institution-based data of surgically treated patients, and the Metastases location, Elderly, Tumor primary, Sex, Sickness/comorbidity, and Site of radiotherapy model (METSSS), trained with registry-based data of patients treated with radiotherapy alone, are two of the most recently developed survival prediction models, but they have not been tested on patients whose local treatment strategy is not yet decided.
(1) Which of these two survival prediction models performed better in a mixed cohort made up both of patients who received local treatment with surgery followed by radiotherapy and who had radiation alone for symptomatic bone metastases? (2) Which model performed better among patients whose local treatment consisted of only palliative radiotherapy? (3) Are laboratory values used by SORG-MLA, which are not included in METSSS, independently associated with survival after controlling for predictions made by METSSS?
Between 2010 and 2018, we provided local treatment for 2113 adult patients with skeletal metastases in the extremities at an urban tertiary referral academic medical center using one of two strategies: (1) surgery followed by postoperative radiotherapy or (2) palliative radiotherapy alone. Every patient's survivorship status was ascertained either by their medical records or the national death registry from the Taiwanese National Health Insurance Administration. After applying a priori designated exclusion criteria, 91% (1920) were analyzed here. Among them, 48% (920) of the patients were female, and the median (IQR) age was 62 years (53 to 70 years). Lung was the most common primary tumor site (41% [782]), and 59% (1128) of patients had other skeletal metastases in addition to the treated lesion(s). In general, the indications for surgery were the presence of a complete pathologic fracture or an impending pathologic fracture, defined as having a Mirels score of ≥ 9, in patients with an American Society of Anesthesiologists (ASA) classification of less than or equal to IV and who were considered fit for surgery. The indications for radiotherapy were relief of pain, local tumor control, prevention of skeletal-related events, and any combination of the above. In all, 84% (1610) of the patients received palliative radiotherapy alone as local treatment for the target lesion(s), and 16% (310) underwent surgery followed by postoperative radiotherapy. Neither METSSS nor SORG-MLA was used at the point of care to aid clinical decision-making during the treatment period. Survival was retrospectively estimated by these two models to test their potential for providing survival probabilities. We first compared SORG to METSSS in the entire population. Then, we repeated the comparison in patients who received local treatment with palliative radiation alone. We assessed model performance by area under the receiver operating characteristic curve (AUROC), calibration analysis, Brier score, and decision curve analysis (DCA). The AUROC measures discrimination, which is the ability to distinguish patients with the event of interest (such as death at a particular time point) from those without. AUROC typically ranges from 0.5 to 1.0, with 0.5 indicating random guessing and 1.0 a perfect prediction, and in general, an AUROC of ≥ 0.7 indicates adequate discrimination for clinical use. Calibration refers to the agreement between the predicted outcomes (in this case, survival probabilities) and the actual outcomes, with a perfect calibration curve having an intercept of 0 and a slope of 1. A positive intercept indicates that the actual survival is generally underestimated by the prediction model, and a negative intercept suggests the opposite (overestimation). When comparing models, an intercept closer to 0 typically indicates better calibration. Calibration can also be summarized as log(O:E), the logarithm scale of the ratio of observed (O) to expected (E) survivors. A log(O:E) > 0 signals an underestimation (the observed survival is greater than the predicted survival); and a log(O:E) < 0 indicates the opposite (the observed survival is lower than the predicted survival). A model with a log(O:E) closer to 0 is generally considered better calibrated. The Brier score is the mean squared difference between the model predictions and the observed outcomes, and it ranges from 0 (best prediction) to 1 (worst prediction). The Brier score captures both discrimination and calibration, and it is considered a measure of overall model performance. In Brier score analysis, the "null model" assigns a predicted probability equal to the prevalence of the outcome and represents a model that adds no new information. A prediction model should achieve a Brier score at least lower than the null-model Brier score to be considered as useful. The DCA was developed as a method to determine whether using a model to inform treatment decisions would do more good than harm. It plots the net benefit of making decisions based on the model's predictions across all possible risk thresholds (or cost-to-benefit ratios) in relation to the two default strategies of treating all or no patients. The care provider can decide on an acceptable risk threshold for the proposed treatment in an individual and assess the corresponding net benefit to determine whether consulting with the model is superior to adopting the default strategies. Finally, we examined whether laboratory data, which were not included in the METSSS model, would have been independently associated with survival after controlling for the METSSS model's predictions by using the multivariable logistic and Cox proportional hazards regression analyses.
Between the two models, only SORG-MLA achieved adequate discrimination (an AUROC of > 0.7) in the entire cohort (of patients treated operatively or with radiation alone) and in the subgroup of patients treated with palliative radiotherapy alone. SORG-MLA outperformed METSSS by a wide margin on discrimination, calibration, and Brier score analyses in not only the entire cohort but also the subgroup of patients whose local treatment consisted of radiotherapy alone. In both the entire cohort and the subgroup, DCA demonstrated that SORG-MLA provided more net benefit compared with the two default strategies (of treating all or no patients) and compared with METSSS when risk thresholds ranged from 0.2 to 0.9 at both 90 days and 1 year, indicating that using SORG-MLA as a decision-making aid was beneficial when a patient's individualized risk threshold for opting for treatment was 0.2 to 0.9. Higher albumin, lower alkaline phosphatase, lower calcium, higher hemoglobin, lower international normalized ratio, higher lymphocytes, lower neutrophils, lower neutrophil-to-lymphocyte ratio, lower platelet-to-lymphocyte ratio, higher sodium, and lower white blood cells were independently associated with better 1-year and overall survival after adjusting for the predictions made by METSSS.
Based on these discoveries, clinicians might choose to consult SORG-MLA instead of METSSS for survival estimation in patients with long-bone metastases presenting for evaluation of local treatment. Basing a treatment decision on the predictions of SORG-MLA could be beneficial when a patient's individualized risk threshold for opting to undergo a particular treatment strategy ranged from 0.2 to 0.9. Future studies might investigate relevant laboratory items when constructing or refining a survival estimation model because these data demonstrated prognostic value independent of the predictions of the METSSS model, and future studies might also seek to keep these models up to date using data from diverse, contemporary patients undergoing both modern operative and nonoperative treatments.
Level III, diagnostic study.
Lee CC
，Chen CW
，Yen HK
，Lin YP
，Lai CY
，Wang JL
，Groot OQ
，Janssen SJ
，Schwab JH
，Hsu FM
，Lin WH
... -
《-》
ResearchGate
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钛学术
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