Biomedical subjects

EU Hernia Trialists Collaboration

Publications and source records attributed to EU Hernia Trialists Collaboration.

8 recordsLinked to original sources

PubMed2004

Value of updating a systematic review in surgery using individual patient data.

BACKGROUND: Previous research has highlighted the advantages of individual patient data (IPD) meta-analyses. However, they are resource intensive and take considerable time to complete. The aim of this study was to determine whether the extra investment is justified by greater accuracy or usefulness by means of a case study in surgery. METHODS: An updated review using IPD, where possible, was compared with an earlier version based on aggregate published data to determine whether there were statistically significant changes in estimates of effectiveness for hernia recurrence and persisting pain. Differences related to the type of laparoscopic repair, the type of open repair and methodological quality were also explored. RESULTS: The results for hernia recurrence changed little. However, the IPD update led to divergent conclusions for persisting pain. The published data implied a statistically significant benefit in favour of open repair, whereas the IPD result implied a statistically significant benefit in favour of laparoscopic repair (P < 0.001). Methodological quality did not account for this difference. CONCLUSION: Updating of systematic reviews using IPD can be conducted successfully in surgery. This example led to little change in estimates of effectiveness for hernia recurrence but yielded qualitatively different estimates for persisting pain, an outcome rarely included in the published reports.

Humans↗

PubMed2004

Cost-effectiveness of alternative methods of surgical repair of inguinal hernia.

OBJECTIVES: To assess the relative cost-effectiveness of laparoscopic methods of inguinal hernia repair compared with open flat mesh and open non-mesh repair. METHODS: Data on the effectiveness of these alternatives came from three systematic reviews comparing: (i) laparoscopic methods with open flat mesh or non-mesh methods; (ii) open flat mesh with open non-mesh repair; and (iii) methods that used synthetic mesh to repair the hernia defect with those that did not. Data on costs were obtained from the authors of economic evaluations previously conducted alongside trials included in the reviews. A Markov model was used to model cost-effectiveness for a five-year period after the initial operation. The outcomes of the model were presented using a balance sheet approach and as cost per hernia recurrence avoided and cost per extra day at usual activities. RESULTS: Open flat mesh was the most cost-effective method of preventing recurrences. Laparoscopic repair provided a shorter period of convalescence and less long-term pain compared with open flat mesh but was more costly. The mean incremental cost per additional day back at usual activities compared with open flat mesh was Euro 38 and Euro 80 for totally extraperitoneal and transabdominal preperitoneal repair, respectively. CONCLUSIONS: Laparoscopic repair is not cost-effective compared with open flat mesh repair in terms of cost per recurrence avoided. Decisions about the use of laparoscopic repair depend on whether the benefits (reduced pain and earlier return to usual activities) outweigh the extra costs and intraoperative risks. On the evidence presented here, these extra costs are unlikely to be offset by the short-term benefits of laparoscopic repair.

Clinical Trials as Topic↗

PubMed2003

Laparoscopic techniques versus open techniques for inguinal hernia repair.

BACKGROUND: Inguinal hernia repair is the most frequently performed operation in general surgery. The standard method for inguinal hernia repair had changed little over a hundred years until the introduction of synthetic mesh. This mesh can be placed by either using an open approach or by using a minimal access laparoscopic technique. Although many studies have explored the relative merits and potential risks of laparoscopic surgery for the repair of inguinal hernia, most individual trials have been too small to show clear benefits of one type of surgical repair over another. OBJECTIVES: The objective of this review was to compare minimal access laparoscopic mesh techniques with open techniques. Comparisons of open mesh techniques versus open non-mesh techniques have been considered in a separate Cochrane review. SEARCH STRATEGY: We searched MEDLINE, EMBASE, and The Cochrane Central Controlled Trials Registry for relevant randomised controlled trials. The reference list of identified trials, journal supplements, relevant book chapters and conference proceedings were searched for further relevant trials. Through the EU Hernia Trialists Collaboration (EUHTC) communication took place with authors of identified randomised controlled trials to ask for information on any other recent and ongoing trials known to them. Specialists involved in research on the repair of inguinal hernia were contacted to ask for information about any further completed and ongoing trials. The world wide web was also searched. SELECTION CRITERIA: All published and unpublished randomised controlled trials and quasi-randomised controlled trials comparing laparoscopic groin hernia repair with open groin hernia repair were eligible for inclusion. Trials were included irrespective of the language in which they were reported. DATA COLLECTION AND ANALYSIS: Individual patient data were obtained, where possible, from the responsible trialist for all eligible studies. All reanalyses were cross-checked by the reviewers and verified by the trialists before inclusion. Where IPD were unavailable additional aggregate data were sought from trialists and published aggregate data checked and verified by the trialists. IPD were available for 25 trials, additional aggregated data for seven and published data only for nine. Where possible, time to event analysis for hernia recurrence and return to usual activities were performed on an intention to treat principle. The main analyses were based on all trials. Sensitivity analyses based on the data source and trial quality were also performed. Pre-defined subgroup analyses based on recurrent hernias, bilateral hernias and femoral hernias were also carried out. MAIN RESULTS: 41 published reports of eligible trials were included involving 7161 participants. Sample sizes ranged from 38 to 994, with follow-up from 6 weeks to 36 months. Duration of operation was longer in the laparoscopic groups (WMD 14.81 minutes, 95% CI 13.98 to 15.64; p<0001). Operative complications were uncommon for both methods but more frequent in the laparoscopic group for visceral (Overall 8/2315 versus 1/2599) and vascular (Overall 7/2498 versus 5/2758) injuries. Length of hospital stay did not differ between groups (WMD -0.04 days, 95% CI -0.08 to 0.00; p=0.05, but return to usual activity was earlier for laparoscopic groups (HR 0.56, 95%CI 0.51 to 0.61; p<0.0001 - equivalent to 7 days). The data available showed less persisting pain (Overall 290/2101 versus 459/2399; Peto OR 0.54, 95% CI 0.46 to 0.64; p<0.0001), and less persisting numbness (Overall 102/1419 versus 217/1624; Peto OR 0.38, 95% CI 0.4286 to 0.49; p<0.0001) in the laparoscopic groups. In total, 86 recurrences were reported amongst 3138 allocated laparoscopic repair and 109 amongst 3504 allocated to open repair (Peto OR 0.81, 95% CI 0.61 to 1.08; p = 0.16). The use of mesh during laparoscopic hernia repair is associated with a reduction in the risk of hernia recurrence, significantly so for the transabdominal preperitoneal repair (TAPP) versus open non-mesh repair (overall 26/1440 versus preperitoneal repair (TAPP) versus open non-mesh repair (overall 26/1440 versus 47/1119; Peto OR 0.45, 95% CI 0.28 to 0.72; p=0.0009). However, no difference was detected when comparing laparoscopic methods with open mesh methods of hernia repair. REVIEWER'S CONCLUSIONS: The use of mesh during laparoscopic hernia repair is associated with a relative reduction in the risk of hernia recurrence of around 30-50%. However, there is no apparent difference in recurrence between laparoscopic and open mesh methods of hernia repair. The data suggests less persisting pain and numbness following laparoscopic repair. Return to usual activities is faster. However, operation times are longer and there appears to be a higher risk of serious complication rate in respect of visceral (especially bladder) and vascular injuries.

Hernia, Inguinal↗

PubMed2002

Open mesh versus non-mesh repair of groin hernia: meta-analysis of randomised trials based on individual patient data [corrected].

BACKGROUND: The EU Hernia Trialists Collaboration was established to provide reliable evaluation of newer methods of groin hernia repair. It involved 70 investigators in 20 countries. MATERIALS AND METHODS: Twenty eligible trials (5016 participants) of open mesh vs. non-mesh groin hernia repair were identified. Meta-analysis was performed using raw individual patient data where possible. RESULTS: Fewer hernia recurrences were reported after mesh repair. There were no clear differences between mesh and non-mesh groups in complications. Overall, those in the mesh groups had a shorter hospital stay, quicker return to usual activities and less frequent persisting pain, but individual trial results varied. CONCLUSIONS: The review provides strong evidence that open mesh repair is associated with a reduction in the risk of recurrence of between 50% and 75%. There is also some evidence of quicker recovery and of lower rates of persisting pain following open mesh repair.

Groin↗

PubMed2002

Laparoscopic versus open groin hernia repair: meta-analysis of randomised trials based on individual patient data.

The EU Hernia Trialists Collaboration was established to provide reliable evaluation of newer methods of groin hernia repair. It involved 70 investigators in 20 countries. The aim was to perform systematic reviews and enhance the value of individual studies by reanalysis of data from randomised controlled trials in meta-analyses. Forty-one eligible trials of laparoscopic versus open groin hernia repair were identified involving 7161 participants (with individual patient data available for 4165). Meta-analysis was performed, using individual patient data where possible. Operation times for laparoscopic repair were longer and there was a higher risk of rare serious complications. Return to usual activities was faster, and there was less persisting pain and numbness. Hernia recurrence was less common than after open non-mesh repair but not different to open mesh methods. The review showed that laparoscopic repair takes longer and has more serious complications, but recovery is quicker with less persisting pain. Reduced hernia recurrence was related to the use of mesh rather than the method of mesh placement.

Hernia, Inguinal↗

PubMed2002

Repair of groin hernia with synthetic mesh: meta-analysis of randomized controlled trials.

OBJECTIVE: To measure the effects of laparoscopic and open placement of synthetic mesh on recurrence and persisting pain following groin hernia repair. SUMMARY BACKGROUND DATA: Synthetic mesh techniques are claimed to reduce the risk of recurrence but there are concerns about costs and possible long-term complications, particularly pain. METHODS: Electronic databases were searched and experts consulted to identify randomized or quasi-randomized trials that compared mesh with non-mesh methods, or laparoscopic with open mesh placement. Individual patient data were sought for each trial. Aggregated data were used where individual patient data were not available. Meta-analyses of hernia recurrence and persisting pain were based on intention to treat. RESULTS: There were 62 relevant comparisons in 58 trials. These included 11,174 participants: individual patient data were available for 6,901 patients, supplementary aggregated data for 2,390 patients, and published data for 1883 patients. Recurrence and persisting pain were less after mesh repair (overall recurrences: 88 in 4,426 vs. 187 in 3,795; OR 0.43, 95% CI 0.34-0.55; P <.001) (overall persistent pain: 120 in 2,368 vs. 215 in 1,998; OR 0.36, 95% CI 0.29-0.46; P <.001), regardless of the non-mesh comparator. Whereas the reduction in recurrence was similar after laparoscopic and open mesh placement (OR 1.26, 95% CI 0.76-2.08; P =.36), persistent pain was less common after laparoscopic than open mesh placement (OR 0.64; 95% CI 0.52-0.78; P <.001). CONCLUSIONS: The use of synthetic mesh substantially reduces the risk of hernia recurrence irrespective of placement method. Mesh repair appears to reduce the chance of persisting pain rather than increase it.

Hernia, Inguinal↗

PubMed2000

Mesh compared with non-mesh methods of open groin hernia repair: systematic review of randomized controlled trials.

BACKGROUND: Open tension-free methods of groin hernia repair have been widely adopted despite little rigorous evaluation. METHODS: Information was assimilated from all randomized or quasi-randomized trials comparing open mesh with open non-mesh methods to assess benefits and safety. Electronic databases were searched and members of the EU Hernia Trialists Collaboration consulted to identify trials. Prespecified data items were extracted from reports, and quantitative or, if not possible, qualitative meta-analysis was performed. RESULTS: Fifteen eligible trials, which included 4005 participants, were identified. There were similar numbers of complications in each group, with few data to address short-term pain and length of stay in hospital. Return to usual activities was quicker in the mesh group for seven of ten trials (P not significant). There were fewer reported recurrences in the mesh groups: overall 21 (1.4 per cent) of 1513 versus 72 (4.4 per cent) of 1634 (odds ratio 0.39 (95 per cent confidence interval 0.25-0. 59); P < 0.001). CONCLUSION: Although the rigorous search maximized trial identification, formal meta-analysis was limited by the variation in trial reporting. Within the data available, mesh repair was associated with fewer recurrences.

Hernia, Inguinal↗

PubMed2000

Laparoscopic compared with open methods of groin hernia repair: systematic review of randomized controlled trials.

BACKGROUND: The place of laparoscopic groin hernia repair remains controversial. Individual randomized controlled trials alone have not provided statistically reliable results when considering recurrence, potentially serious complications and chronic pain. METHODS: A rigorous systematic review was performed of published data from all relevant randomized or quasi-randomized trials. Electronic databases were searched and members of the EU Hernia Trialists Collaboration consulted to identify trials. Prespecified data items were extracted from reports and, where possible, quantitative meta-analysis was performed. RESULTS: Thirty-four published reports of eligible trials were included, involving 6804 participants. Sample sizes ranged from 20 to 1051, with follow-up from 6 weeks to 36 months. Duration of operation was longer in the laparoscopic groups (P < 0.001, Sign test). Operative complications were uncommon for both methods, but visceral and vascular injuries were more frequent in the laparoscopic group (4.7 per 1000 versus 1. 1 per 1000). Postoperative pain was less among laparoscopic groups (P = 0.08). Length of hospital stay did not differ significantly between groups (P = 0.50), but return to usual activity was earlier for laparoscopic groups (P < 0.001). Chronic pain and numbness were reported for only a small minority of trials. Overall, recurrences did not differ between groups, but comparison of laparoscopic with open non-mesh repair favoured laparoscopic methods, significantly so for transabdominal preperitoneal repair (Peto odds ratio 0.56 (95 per cent confidence interval 0.33-0.93); P = 0.026). CONCLUSION: Although the rigorous search maximized trial identification, variation in trial reporting made formal meta-analysis difficult. Laparoscopic repair was associated with less postoperative pain and more rapid return to normal activities, but it takes longer to perform and may increase the risk of rare, but serious, complications.

Hernia, Inguinal↗