Authors' objectives

To evaluate recently introduced open mesh repair techniques (Kugel Patch, the PerFix Plug and the Prolene Hernia System) for repairing inguinal hernias.

Searching

MEDLINE, EMBASE, and the Cochrane Library were searched. Details of the keywords and search strategy were given. References in identified studies, reviews, textbooks and material produced by manufacturers of the repair systems were also checked. The manufacturers of repair systems were contacted for details of trials of their products.

Study selection

Assessment of study quality

The studies were graded using a hierarchy of evidence. Non RCTs were discussed in terms of the study design, sample size and power, blinding, adequacy of information on potential confounding factors, adequacy of definition of outcome measures, and the methods used to assess the outcome. The authors did not state how the papers were assessed for validity, or how many reviewers performed the validity assessment.

Data extraction

The authors did not state how the data were extracted for the review, or how many reviewers performed the data extraction. The tabulated information included sample size, minimum surgical experience, duration of follow-up, and the percentage of patients in continuing contact.

Methods of synthesis

Results of the review

Eight studies (3,244 patients) were included: one RCT (140 patients), one non-randomised controlled study (45 patients), one study with a historical control (1,011 patients) and five uncontrolled studies (2,048 patients).

None of the studies directly compared the different open mesh techniques.

There was only one good-quality RCT. The other studies had major methodological flaws, e.g. inadequate details of potential confounding factors, inadequate definition of outcome measures, and inadequate follow-up.

The one good-quality RCT (140 patients) compared the PerFix Plug with the Lichtenstein patch. There was no significant difference between the techniques in terms of acute post-operative pain or use of analgesia, time to return to work or normal activities, and operative complications. The RCT also reported that the PerFix Plug required a significantly smaller incision than the Lichtenstein plug (4.9 versus 7.6 cm, P<0.001) and a significantly shorter operating time (32.0 versus 37.6 minutes, P<0.001), and it led to significantly improved physical function on the third post-operative day (P=0.013). The duration of follow-up was 14 days.

Over all the studies, the recurrence rates were 0.6 and 2.2% for the Kugel patch, 0% for the Prolene Hernia System, and 0, 2 and 8% for the PerFix plug. None of the studies assessed long-term or chronic post-operative pain.

Cost information

The RCT reported that the costs were $100 greater with the PerFix plug than with the Lichtenstein patch. One study found that the Kugel patch was $776 cheaper than laparoscopy.

Authors' conclusions

The results from the one good-quality RCT identified suggested that the PerFix Plug repair reduces insertion time and requires a smaller incision. The authors also concluded that there is a need for research into chronic post hernia repair pain after elective mesh repair of primary unilateral hernias.

CRD commentary

The review question was clear in terms of the intervention and participants, although no inclusion criteria were explicitly defined. Several relevant sources were searched, attempts were made to locate unpublished studies, and the search terms were stated. However, it was not stated whether studies in any language were eligible for inclusion. The methods used to select the studies, assess validity and extract the data were not described, thus it was unclear whether any attempts were made to reduce bias and errors by duplicating these processes. Validity was assessed and the results were discussed taking validity into account.

Some relevant information on the included studies was tabulated but for the controlled studies, apart from the one RCT, it was unclear what treatment the comparison group received. The characteristics of the patients were not described, so it is not possible to assess whether the results are generalisable to all patients with inguinal hernias. Given the methodological problems of most of the included studies, it seems appropriate to have limited the results to those from the one RCT. However, the limitations of the evidence from this, which reported only short-term follow-up in comparison with one comparator technique, need highlighting; the results may not apply to all patients in all settings. The authors' conclusions should be considered with caution in view of the limitations of the evidence.

Implications of the review for practice and research

Practice: The authors did not state any implications for practice.

Research: The authors stated the need for a multicentre RCT to evaluate chronic post hernia repair pain after elective mesh repair of primary unilateral hernias.

Bibliographic details

Zib M, Gani J. Inguinal hernia repair: where to next? ANZ Journal of Surgery 2002; 72(8): 573-579. [PubMed: 12190732]

Indexing Status

Subject indexing assigned by NLM

MeSH

Digestive System Surgical Procedures /trends; Hernia, Inguinal /surgery; Humans; Research /trends; Surgical Mesh /trends

AccessionNumber

12002002049

Database entry date

31/05/2004

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.