Mesh fixation techniques in primary ventral or incisional hernia repair.

BACKGROUND: The use of a mesh in primary ventral or incisional hernia repair lowers the recurrence rate  and is the accepted standard of care for larger defects. In laparoscopic primary ventral or incisional hernia repair the insertion of a mesh is indispensable. Different mesh fixation techniques have been used and refined over the years. The type of fixation technique is claimed to have a major impact on recurrence rates, chronic pain, health-related quality of life (HRQOL) and complication rates. OBJECTIVES: To determine the impact of different mesh fixation techniques for primary and incisional ventral hernia repair on hernia recurrence, chronic pain, HRQOL and complications. SEARCH METHODS: On 2 October 2020 we searched CENTRAL, MEDLINE (Ovid MEDLINE(R)) Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R)), Ovid Embase, and two trials registries. We also performed handsearches, and contacted experts from the European Hernia Society (EHS). SELECTION CRITERIA: We included randomised controlled trials (RCTs) including adults with primary ventral or incisional hernia that compared different types of mesh fixation techniques (absorbable/nonabsorbable sutures, absorbable/nonabsorbable tacks, fibrin glue, and combinations of these techniques). DATA COLLECTION AND ANALYSIS: We extracted data in standardised piloted tables, or if necessary, directly into Review Manager 5. We assessed risks of bias with the Cochrane 'Risk of bias' tool. Two review authors independently selected the publications, and extracted data on results. We calculated risk ratios (RRs) for binary outcomes and mean differences (MDs) for continuous outcomes. For pooling we used an inverse-variance random-effects meta-analysis or the Peto method in the case of rare events. We prepared GRADE 'Summary of findings' tables. For laparoscopic repair we considered absorbable tacks compared to nonabsorbable tacks, and nonabsorbable tacks compared to nonabsorbable sutures as key comparisons. MAIN RESULTS: We included 10 trials with a total of 787 participants. The number of randomised participants ranged from 40 to 199 per comparison. Eight studies included participants with both primary and incisional ventral hernia. One study included only participants with umbilical hernia, and another only participants with incisional hernia. Hernia size varied between studies. We judged the risk of bias as moderate to high. Absorbable tacks compared to nonabsorbable tacks Recurrence rates in the groups were similar (RR 0.74, 95% confidence interval (CI) 0.17 to 3.22; 2 studies, 101 participants). It is uncertain whether there is a difference between absorbable tacks and nonabsorbable tacks in recurrence because the certainty of evidence was very low. Evidence suggests that the difference between groups in early postoperative, late follow-up, chronic pain and HRQOL is negligible. Nonabsorbable tacks compared to nonabsorbable sutures At six months there was one recurrence in each group (RR 1.00, 95% CI 0.07 to 14.79; 1 study, 36 participants). It is uncertain whether there is a difference between nonabsorbable tacks and nonabsorbable sutures in recurrence because the certainty of evidence was very low. Evidence suggests that the difference between groups in early postoperative, late follow-up and chronic pain is negligible. We found no study that assessed HRQOL. Absorbable tacks compared to absorbable sutures No recurrence was observed at one year (very low certainty of evidence). Early postoperative pain was higher in the tacks group (VAS 0 - 10: MD -2.70, 95% CI -6.67 to 1.27; 1 study, 48 participants). It is uncertain whether there is a difference between absorbable tacks compared to absorbable sutures in early postoperative pain because the certainty of evidence was very low. The MD for late follow-up pain was -0.30 (95% CI -0.74 to 0.14; 1 study, 48 participants). We found no study that assessed HRQOL. Combination of different fixation types (tacks and sutures) or materials (absorbable and nonabsorbable) There were mostly negligible or only small differences between combinations (e.g. tacks plus sutures) compared to a single technique (e.g. sutures only), as well as combinations compared to other combinations (e.g. absorbable sutures combined with nonabsorbable sutures compared to absorbable tacks combined with nonabsorbable tacks) in all outcomes. It is uncertain whether there is an advantage for combining different fixation types or materials for recurrence, chronic pain, HRQOL and complications, because the evidence certainty was very low or low, or we found no study on important outcomes. Nonabsorbable tacks compared to fibrin sealant The two studies showed different directions of effects: one showed higher rates for nonabsorbable tacks, and the other showed higher rates for fibrin sealant. Low-certainty evidence suggests that the difference between groups in early postoperative, late follow-up, chronic pain and HRQOL is negligible. Absorbable tacks compared to fibrin sealant One recurrence in the tacks group and none in the fibrin sealant group were noted after one year (low certainty of evidence). Early postoperative pain might be slightly lower using tacks (VAS 0 - 100; MD -12.40, 95% CI -27.60 to, 2.80;1 study, 50 participants; low-certainty evidence). The pattern of pain and HRQOL course over time (up to 1 year) was similar in the groups (low certainty of evidence). AUTHORS' CONCLUSIONS: Currently none of the techniques can be considered superior to any other, because the certainty of evidence was low or very low for all outcomes.

Suture Versus Mesh Repair in Primary and Incisional Ventral Hernias: A Systematic Review and Meta-Analysis.

BACKGROUND: Today, ventral hernia repair is predominantly performed with meshes. There is no meta-analysis of high quality evidence that compares the results of suture to mesh repair. The objective of this systematic review with meta-analysis is to compare patient centred outcomes of suture versus mesh repair. METHODS: A systematic literature search was performed in EMBASE, MEDLINE and CENTRAL (inception to 06/2014). Furthermore a hand search was performed. RCTs comparing suture versus mesh repair in primary and incisional ventral hernia repair were included. Data on patient characteristics, interventions and results were extracted in standardized tables. Risk of bias was assessed with the cochrane risk of bias tool. Results of studies were pooled with a meta-analysis. All steps were performed by two reviewers. Discrepancies were discussed until a consensus. RESULTS: The search in the databases resulted in 1560 hits. After screening, 10 randomized controlled trials including 1215 patients satisfied all inclusion criteria. Risk of bias was moderate to high. The relative risk for recurrence was 0.36 [95% CI (0.27, 0.49); I (2) = 0; heterogeneity p = 0.70]. Other complications did not differ significantly. Results for chronic pain were heterogeneous across studies. CONCLUSION: Mesh repair reduces the number of recurrences significantly. In patients without recurrence mesh repairs seem to be associated with a risk of chronic pain especially if the mesh is fixed sublay.

Methods for systematic reviews of health economic evaluations: a systematic review, comparison, and synthesis of method literature.

INTRODUCTION: The quality of systematic reviews of health economic evaluations (SR-HE) is often limited because of methodological shortcomings. One reason for this poor quality is that there are no established standards for the preparation of SR-HE. The objective of this study is to compare existing methods and suggest best practices for the preparation of SR-HE. METHODS: To identify the relevant methodological literature on SR-HE, a systematic literature search was performed in Embase, Medline, the National Health System Economic Evaluation Database, the Health Technology Assessment Database, and the Cochrane methodology register, and webpages of international health technology assessment agencies were searched. The study selection was performed independently by 2 reviewers. Data were extracted by one reviewer and verified by a second reviewer. On the basis of the overlaps in the recommendations for the methods of SR-HE in the included papers, suggestions for best practices for the preparation of SR-HE were developed. RESULTS: Nineteen relevant publications were identified. The recommendations within them often differed. However, for most process steps there was some overlap between recommendations for the methods of preparation. The overlaps were taken as basis on which to develop suggestions for the following process steps of preparation: defining the research question, developing eligibility criteria, conducting a literature search, selecting studies, assessing the methodological study quality, assessing transferability, and synthesizing data. DISCUSSION: The differences in the proposed recommendations are not always explainable by the focus on certain evaluation types, target audiences, or integration in the decision process. Currently, there seem to be no standard methods for the preparation of SR-HE. The suggestions presented here can contribute to the harmonization of methods for the preparation of SR-HE.

Efficacy and safety of sclerotherapy with polidocanol foam in comparison with fluid sclerosant in the treatment of first-grade haemorrhoidal disease: a randomised, controlled, single-blind, multicentre trial.

PURPOSE: Sclerotherapy is the treatment of choice for first-grade haemorrhoidal disease. Numerous studies have shown that sclerotherapy with foamed sclerosants is more efficacious than liquid in the treatment of varicose veins. The aim of this study was to assess the efficacy and safety of polidocanol foam in comparison with liquid for haemorrhoidal disease. METHODS: A total of 130 patients were randomised to foam or liquid sclerotherapy (polidocanol 3%). Patients with first-grade haemorrhoidal disease were included and blinded to treatment assignment. The primary endpoint was the stopping of perianal bleeding after one sclerotherapy session. Sclerotherapy was repeated until patients were free of bleeding (2-week intervals). The final follow-up was 12 weeks after the last sclerotherapy session. RESULTS: In the foam group, significantly more patients (88%) were treated successfully after one sclerotherapy session compared to the liquid group (69%; p = 0.01). There was high patient satisfaction in both groups, but significantly more patients were satisfied with their treatment in the foam group than in the liquid group (99 vs. 84%; p = 0.009). Additionally, in the foam group, significantly less treatment sessions were required (p < 0.001), and the total amount of injected polidocanol was reduced (p < 0.001). CONCLUSION: In the therapy of first-grade haemorrhoidal disease, polidocanol 3 % foam is more effective and equally safe compared to liquid polidocanol. The results of this trial show that foam sclerotherapy is a new, innovative, effective and safe non-surgical treatment option for haemorrhoidal disease.

Laparoscopic versus open surgical techniques for ventral or incisional hernia repair.

BACKGROUND: There are many different techniques currently in use for ventral and incisional hernia repair. Laparoscopic techniques have become more common in recent years, although the evidence is sparse. OBJECTIVES: We compared laparoscopic with open repair in patients with (primary) ventral or incisional hernia. SEARCH STRATEGY: We searched the following electronic databases: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, metaRegister of Controlled Trials. The last searches were conducted in July 2010. In addition, congress abstracts were searched by hand. SELECTION CRITERIA: We selected randomised controlled studies (RCTs), which compared the two techniques in patients with ventral or incisional hernia. Studies were included irrespective of language, publication status, or sample size. We did not include quasi-randomised trials. DATA COLLECTION AND ANALYSIS: Two authors assessed trial quality and extracted data independently. Meta-analytic results are expressed as relative risks (RR) or weighted mean difference (WMD). MAIN RESULTS: We included 10 RCTs with a total number of 880 patients suffering primarily from primary ventral or incisional hernia. No trials were identified on umbilical or parastomal hernia. The recurrence rate was not different between laparoscopic and open surgery (RR 1.22; 95% CI 0.62 to 2.38; I(2) = 0%), but patients were followed up for less than two years in half of the trials. Results on operative time were too heterogeneous to be pooled. The risk of intraoperative enterotomy was slightly higher in laparoscopic hernia repair (Peto OR 2.33; 95% CI 0.53 to 10.35), but this result stems from only 7 cases with bowel lesion (5 vs. 2). The most clear and consistent result was that laparoscopic surgery reduced the risk of wound infection (RR = 0.26; 95% CI 0.15 to 0.46; I(2)= 0%). Laparoscopic surgery shortened hospital stay significantly in 6 out of 9 trials, but again data were heterogeneous. Based on a small number of trials, it was not possible to detect any difference in pain intensity, both in the short- and long-term evaluation. Laparoscopic repair apparently led to much higher in-hospital costs. AUTHORS' CONCLUSIONS: The short-term results of laparoscopic repair in ventral hernia are promising. In spite of the risks of adhesiolysis, the technique is safe. Nevertheless, long-term follow-up is needed in order to elucidate whether laparoscopic repair of ventral/incisional hernia is efficacious.