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Diathermy versus scalpel for skin incision in patients undergoing open inguinal hernia repair: A systematic review and meta-analysis
Journal Pre-proof Diathermy versus scalpel for skin incision in patients undergoing open inguinal hernia repair: A systematic review and meta-analysis Shahab Hajibandeh, Shahin Hajibandeh, Andrew Maw PII:
S1743-9191(20)30030-3
DOI:
https://doi.org/10.1016/j.ijsu.2020.01.020
Reference:
IJSU 5227
To appear in:
International Journal of Surgery
Received Date: 21 November 2019 Accepted Date: 17 January 2020
Please cite this article as: Hajibandeh S, Hajibandeh S, Maw A, Diathermy versus scalpel for skin incision in patients undergoing open inguinal hernia repair: A systematic review and meta-analysis International Journal of Surgery, https://doi.org/10.1016/j.ijsu.2020.01.020. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
Diathermy versus scalpel for skin incision in patients undergoing open inguinal hernia repair: A systematic review and meta-analysis Shahab Hajibandeh,1*# Shahin Hajibandeh,2* Andrew Maw.1 1- Department of Colorectal and General Surgery, Glan Clwyd Hospital, Rhyl, UK 2- Department of General Surgery, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK
* Shahab Hajibandeh and Shahin Hajibandeh equally contributed to this paper and joined first authorship is proposed
# Corresponding author: Shahab Hajibandeh Address: Department of Colorectal and General Surgery, Glan Clwyd Hospital, Rhyl, Denbighshire, UK E-mail: [email protected] ; tel: +44 7766106423
Key words: scalpel; diathermy; inguinal hernia
There are no funding sources for this work, no conflicts of interest and no financial disclosures for all the authors.
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Diathermy versus scalpel for skin incision in patients undergoing open inguinal hernia repair:
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A systematic review and meta-analysis
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Key words: scalpel; diathermy; inguinal hernia
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There are no funding sources for this work, no conflicts of interest and no financial disclosures for all the authors.
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ABSTRACT
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Objectives: To compare outcomes of diathermy and scalpel for skin incision in patients undergoing open inguinal hernia repair.
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Methods: We performed a systematic review in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement standards. We conducted a search of electronic information sources to identify all randomised controlled trials (RCTs) and observational studies comparing use of diathermy and scalpel for skin incision in patients undergoing inguinal hernia repair. Surgical site infection (SSI) was the primary outcome measure. Secondary outcome measures included haematoma, seroma, visual analogue scale (VAS) pain score at 6 hours, 12 hours, and 24 hours, and incision time. We used Cochrane risk of bias tool and ROBINS-I tool to assess the risk of bias of randomised and non-randomised studies. Fixed-effect model was applied to calculate pooled outcome data.
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Results: We identified 9 studies, 4 randomised controlled trials and 5 prospective cohort studies, enrolling a total of 830 patients. Meta-analysis of RCTs showed no difference between the diathermy and scalpel groups in terms of surgical site infection (OR: 0.77, 95% CI 0.34, 1.75, P=0.53), seroma (OR: 0.86, 95% CI 0.29, 2.55, P=0.78), VAS pain score at 6 hours (MD: -0.10, 95% CI -0.31, 0.11, P=0.34), 12 hours (MD: -0.10, 95% CI -0.13, 0.33, P=0.40), and 24 hours (MD: 0.03, 95% CI -0.16, 0.21, P=0.79). Use of diathermy for skin incision was associated with shorter incision time (MD: 36.00, 95% CI -47.92, -24.08, P<0.00001) and lower risk of haematoma (OR: 0.14, 95% CI 0.03, 0.65, P=0.01). Meta-analysis of observational studies showed no difference between the diathermy and scalpel groups in terms of surgical site infection (OR: 0.87, 95% CI 0.54, 1.39, P=0.55), haematoma (OR 0.14, 95% CI 0.02-1.23, P = 0.08), seroma (OR: 0.86, 95% CI 0.29, 2.55, P=0.78), VAS pain score at 6 hours (MD: -0.10, 95% CI -0.44, 0.24, P=0.56), 12 hours (MD: -0.10, 95% CI 0.26, 0.46, P=0.58), and 24 hours (MD: 0.10, 95% CI -0.27, 0.47, P=0.59). Use of diathermy for skin incision was associated with shorter incision time (MD: -39.40, 95% CI -41.02, -37.78, P<0.00001). The results remained consistent through sensitivity analyses. The between-study heterogeneity was low and the quality of the available evidence was moderate.
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Conclusions: There is no difference between use of diathermy and scalpel for skin incision in patients undergoing open inguinal hernia repair in terms of surgical site infection, seroma and postoperative pain. Use of diathermy for skin incision may be associated with shorter incision time and may reduce the risk of haematoma formation.
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INTRODUCTION
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Surgical skin incisions can be made with scalpel or cutting diathermy. Making incision using scalpel
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involves cutting through skin using a sharp blade while cutting diathermy incises skin by generating
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heat. An optimum technique for making skin incision should allow precise incision with minimal risk
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of bleeding and surgical site infection (SSI). The potential advantages of diathermy use for making
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skin incision may include incision-related blooding, and dry and rapid tissue separation.1 However, it
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may be associated with collateral heat damage, impaired wound healing, excessive scarring and
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potentially higher risk of SSI due to necrosis at the wound edges.2-4
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Inguinal hernia repair is one of the most common general surgical procedures performed worldwide.
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Although wound complications following inguinal hernia repair is uncommon, they are associated
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with increased risk of hernia recurrence and consequent morbidity.5 Therefore, minimising the risk of
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wound complications following inguinal hernia repair is crucial. Whether the technique used for
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making skin incision in patients undergoing inguinal hernia repair can influence the risk of wound
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complications remains unknown. The use of scalpel versus diathermy for making skin incision in
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open inguinal hernia repair have been compared in some studies making performing a systematic
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review worthwhile.
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In this study, we aimed to perform a systematic review and meta-analysis to compare the outcomes of
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diathermy and scalpel for skin incision in patients undergoing open inguinal hernia repair.
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METHODS
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This review was performed according to a predefined protocol (PROSPERO registration number:
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CRD42019157996) in compliance with the Preferred Reporting Items for Systematic Reviews and
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Meta-Analyses (PRISMA) statement standards6 and AMSTAR (Assessing the methodological quality
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of systematic reviews) Guidelines.
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Criteria for considering studies for this review
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Types of studies
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All randomised controlled trials (RCTs) and observational studies comparing diathermy and scalpel
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for skin incision in patients undergoing open inguinal hernia repair.
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Types of participants
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The participants of interest in this study were patients of any age and gender undergoing open
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inguinal hernia repair. The list of open inguinal hernia repair techniques of interest was not exhaustive
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and included open mesh repair techniques (Lichtenstein, plug and patch, Prolene mesh system, Kugel, 3
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Stoppa, Trabucco, Wantz, or Robbins techniques) or open non-mesh techniques (Shouldice, Bassini,
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McVay, Halste, Darn, or Desarda techniques).
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Types of interventions
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The use of diathermy for skin incision was considered as intervention of interest and the use of a
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scalpel for skin incision was considered as comparison of interest.
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Types of outcome measures
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Primary Outcome
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Surgical site infection (SSI)
Secondary outcomes
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•
Haematoma
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•
Seroma
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Visual analogue scale (VAS) pain score at 6 hours, 12 hours, and 24 hours postoperatively
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•
Incision time
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Search methods for identification of studies
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Electronic searches
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Two authors independently searched the following electronic databases: MEDLINE, EMBASE,
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Scopus, CINAHL, and the Cochrane Central Register of Controlled Trials (CENTRAL). The last
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search was run on 10 September 2019. Thesaurus headings, search operators and limits in each of the
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above databases were adapted accordingly. The literature search strategy is outlined in Appendix I. In
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addition,
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(http://apps.who.int/trialsearch/), ClinicalTrials.gov (http://clinicaltrials.gov/) and ISRCTN Register
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(http://www.isrctn.com/) were searched for details of ongoing and unpublished studies. No language
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restrictions were applied in our search strategies. The bibliographic lists of relevant articles and
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reviews were also searched for further potentially eligible trials.
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Data collection and analysis
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Selection of studies
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The title and abstract of articles identified from the literature searches were assessed independently by
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two authors. The full-texts of relevant reports were retrieved and those articles that met the eligibility
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criteria of our review were selected. Any discrepancies in study selection were resolved by discussion
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between the authors. An independent third author was consulted in the event of disagreement.
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Data extraction and management
World
Health
Organization
International
Clinical
Trials
Registry
4
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We created an electronic data extraction spreadsheet in line with Cochrane’s data collection form for
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intervention reviews. The spreadsheet was pilot-tested in randomly selected articles and was adjusted
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accordingly. It included study-related data (first author, year of publication, country of origin of the
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corresponding author, journal in which the study was published, study design, study size, clinical
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condition of the study participants, type of intervention and comparison), baseline demographic and
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clinical information of the included populations, and outcome data. Two authors independently
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collected and recorded data in the data extraction spreadsheet and disagreements were resolved by
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discussion. If no agreement could be reached, a third author was consulted.
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Assessment of risk of bias in included studies
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The Cochrane tool that categorises studies into low, unclear, and high risk of bias in terms of selection
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bias, detection bias, performance bias, reporting bias, attrition bias, and other sources of bias was used
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for methodological quality assessment of RCTs. The Risk Of Bias In Non-randomized Studies – of
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Interventions (ROBINS-I) assessment tool was used for methodological quality assessment of
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observational studies in terms of the following domains: bias due to confounding, bias in selection of
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participants into the study, bias in classification of interventions, bias due to deviations from intended
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intervention, bias due to missing data, bias in measurement of outcomes, and bias in selection of the
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reported result. Methodological quality assessment was performed by two independent authors and in
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case of disagreements a third independent author was consulted.
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Data synthesis and statistical analyses
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The odds ratio (OR) and mean difference (MD) were calculated as summary measures for
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dichotomous and continuous outcome variables, respectively. An individual hernia was considered as
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the unit of analysis. Information about dropouts, withdrawals, and other missing data were recorded,
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and if not reported, the study authors were contacted where possible. The analyses were based on
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intention to- treat data from the individual clinical studies. We used the Review Manager 5.3
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(RevMan, Version 5.3. Copenhagen, 2014) software for data synthesis.6 Random or fixed effects
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modelling were applied as appropriate for analyses; random effects models were used if significant
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heterogeneity was noted among the studies. The Cochran Q test (χ2) was used to evaluate
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heterogeneity and I2 was reported to quantify it. In terms of interpretation of I2, we considered I2 of 0-
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50% as low heterogeneity, 50-75% as moderate heterogeneity and 75-100% as high heterogeneity.
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We planned to construct funnel plots and evaluate their symmetry to visually assess publication bias
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for outcomes reported by at least 10 studies where possible.
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Sensitivity and subgroup analyses
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The robustness of the primary analyses were evaluated further by additional analyses for the outcomes
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that were reported by at least 4 studies. First, the risk ratio (RR) and risk difference (RD) were 5
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calculated instead of OR for dichotomous variables. Then, the primary analyses were repeated using
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the random effects and fixed effect models. Furthermore, in order to determine the influence of each
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study on the overall effect size and heterogeneity, each study was eliminated at a time and the analysis
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was repeated. We planned to perform separate analyses for RCTs with low risk of selection bias in
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terms of allocation concealment and randomisation. Where possible, we aimed to perform subgroup
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analysis based on type of open hernia repair (mesh vs non-mesh techniques).
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RESULTS
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Results of the search
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Overall, 98 articles were identified after applying the search strategy in the aforementioned databases.
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Among the studies that were identified through search of electronic databases, 89 articles were not
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relevant to the topic of this study and were excluded directly. The remaining 9 studies8-16 were
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relevant to the topic of this study and, after assessing their full-texts, all were considered eligible for
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inclusion in this study. These included 4 RCTs8-11 and 5 prospective cohort studies12-16 enrolling a
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total of 830 patients with 830 hernias. All studies included patients undergoing open inguinal hernia
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repair. Overall, 415 patients with 415 hernias were included in the diathermy group and 415 patients
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with 415 hernias were included in the scalpel group. The literature search flow chart and baseline
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characteristics of the included studies are demonstrated in Figure 1 and Table 1, respectively.
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Risk of bias in included studies
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The summary and results of methodological quality assessment of the 4 RCTs8-11 and 5 prospective
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cohort studies12-16 are demonstrated graphically in Figure 2.
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Outcome synthesis
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Surgical site infection
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All studies. SSI was reported in nine studies,8-16 including 830 hernia repairs (Figure 3). There was no
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difference in the risk of SSI between the diathermy and scalpel groups (OR 0.84, 95% CI 0.56-1.27, P
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= 0.41). A low level of heterogeneity among the studies existed (I2 = 0%, P = 1.0).
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Randomised controlled trials. SSI was reported in four RCTs,8-11 including 260 hernia repairs (Figure
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3). There was no significant difference in the risk of SSI between the diathermy and scalpel groups
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(OR 0.77, 95% CI 0.34-1.75, P = 0.53). A low level of heterogeneity among the studies existed (I2 =
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0%, P = 0.95).
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Observational studies. SSI was reported in five observational studies,12-16 including 570 hernia repairs
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(Figure 3). There was no significant difference in the risk of SSI between the diathermy and scalpel 6
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groups (OR 0.87, 95% CI 0.54-1.39, P = 0.55). A low level of heterogeneity among the studies
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existed (I2 = 0%, P = 0.92).
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Haematoma
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All studies. Haematoma was reported in three studies,9,10,14 including 180 hernia repairs (Figure 3).
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Use of diathermy was associated with a lower risk of haematoma compared with use of scalpel (OR
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0.14, 95% CI 0.04-1.49, P = 0.002). A low level of heterogeneity among the studies existed (I2 = 0%,
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P = 1.00).
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Randomised controlled trials. Haematoma was reported in two RCTs,9,10 including 120 hernia repairs
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(Figure 3). Use of diathermy was associated with a lower risk of haematoma compared with use of
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scalpel (OR 0.14, 95% CI 0.03-0.65, P = 0.01). A low level of heterogeneity among the studies
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existed (I2 = 0%, P = 1.00).
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Observational studies. Haematoma was reported in one observational study,14 including 60 hernia
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repairs (Figure 3). There was no difference in the risk of haematoma between the diathermy and
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scalpel groups (OR 0.14, 95% CI 0.02-1.23, P = 0.08).
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Seroma
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All studies. Seroma was reported in two studies,10,14 including 120 hernia repairs (Figure 3). There
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was no difference in the risk of seroma between the diathermy and scalpel groups (OR 0.86, 95% CI
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0.40-1.85, P = 0.69). A low level of heterogeneity among the studies existed (I2 = 0%, P = 1.00).
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Randomised controlled trials. Seroma was reported in one RCT,10 including 60 hernia repairs (Figure
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3). There was no difference in the risk of seroma between the diathermy and scalpel groups (OR 0.86,
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95% CI 0.29-2.55, P = 0.78).
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Observational studies. Seroma was reported in one observational study,14 including 60 hernia repairs
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(Figure 3). There was no difference in the risk of seroma between the diathermy and scalpel groups
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(OR 0.86, 95% CI 0.29-2.55, P = 0.78).
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VAS pain score at 6 hours
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All studies. VAS pain score at 6 hours was reported in three studies,8,10,14 including 200 hernia repairs
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(Figure 3). There was no difference in VAS pain score at 6 hours between the diathermy and scalpel
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groups (MD -0.10, 95% CI -0.28-0.08, P = 0.27). A low level of heterogeneity among the studies
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existed (I2 = 0%, P = 1.00).
7
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Randomised controlled trials. VAS pain score at 6 hours was reported in two RCTs,8,10 including 140
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hernia repairs (Figure 3). There was no difference in VAS pain score at 6 hours between the
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diathermy and scalpel groups (MD -0.10, 95% CI -0.31-0.11, P = 0.34). A low level of heterogeneity
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among the studies existed (I2 = 0%, P = 1.00).
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Observational studies. VAS pain score at 6 hours was reported in one observational study,14 including
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60 hernia repairs (Figure 3). There was no difference in VAS pain score at 6 hours between the
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diathermy and scalpel groups (MD -0.10, 95% CI -0.44-0.24, P = 0.56).
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VAS pain score at 12 hours
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All studies. VAS pain score at 12 hours was reported in three studies,8,10,14 including 200 hernia
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repairs (Figure 3). There was no difference in VAS pain score at 12 hours between the diathermy and
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scalpel groups (MD 0.10, 95% CI -0.10-0.30, P = 0.32). A low level of heterogeneity among the
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studies existed (I2 = 0%, P = 1.00).
242
Randomised controlled trials. VAS pain score at 12 hours was reported in two RCTs,8,10 including
243
140 hernia repairs (Figure 3). There was no difference in VAS pain score at 12 hours between the
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diathermy and scalpel groups (MD 0.10, 95% CI -0.13-0.33, P = 0.40). A low level of heterogeneity
245
among the studies existed (I2 = 0%, P = 1.00).
246
Observational studies. VAS pain score at 12 hours was reported in one observational study,14
247
including 60 hernia repairs (Figure 3). There was no difference in VAS pain score at 12 hours
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between the diathermy and scalpel groups (MD 0.10, 95% CI -0.26-0.46, P = 0.58).
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VAS pain score at 24 hours
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All studies. VAS pain score at 24 hours was reported in three studies,8,10,14 including 200 hernia
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repairs (Figure 3). There was no difference in VAS pain score at 24 hours between the diathermy and
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scalpel groups (MD 0.04, 95% CI -0.13-0.21, P = 0.63). A low level of heterogeneity among the
253
studies existed (I2 = 0%, P = 0.85).
254
Randomised controlled trials. VAS pain score at 24 hours was reported in two RCTs,8,10 including
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140 hernia repairs (Figure 3). There was no difference in VAS pain score at 24 hours between the
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diathermy and scalpel groups (MD 0.03, 95% CI -0.16-0.21, P = 0.79). A low level of heterogeneity
257
among the studies existed (I2 = 0%, P = 0.65).
258
Observational studies. VAS pain score at 24 hours was reported in one observational study,14
259
including 60 hernia repairs (Figure 3). There was no difference in VAS pain score at 24 hours
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between the diathermy and scalpel groups (MD 0.10, 95% CI -0.27-0.47, P = 0.59). 8
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Incision time
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All studies. Incision time was reported in two studies,11,14 including 120 hernia repairs (Figure 3). Use
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of diathermy was associated with shorter incision time compared with use of scalpel (MD -39.34,
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95% CI -40.94 - -37.73, P < 0.00001). A low level of heterogeneity among the studies existed (I2 =
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0%, P =0.58).
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Randomised controlled trials. Incision time was reported in one RCT,11 including 60 hernia repairs
267
(Figure 3). Use of diathermy was associated with shorter incision time compared with use of scalpel
268
(MD -36.00, 95% CI -47.92 - -24.08, P < 0.00001).
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Observational studies. Incision time was reported in one observational study,14 including 60 hernia
270
repairs (Figure 3). Use of diathermy was associated with shorter incision time compared with use of
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scalpel (MD -39.40, 95% CI -41.02 - -37.78, P < 0.00001).
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Additional analyses
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Sensitivity analyses
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Sensitivity analyses were performed for SSI that was reported by more than four studies. Removing
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one study at a time did not change the direction of the effect size and the overall heterogeneity. The
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direction of the effect size remained unchanged when ORs, RRs or RDs were calculated separately.
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The use of random effects or fixed effect models did not affect the direction of the effect size.
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Separate analyses for studies with low or moderate risk of bias did not affect the direction of the effect
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size.
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Subgroup analysis
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The available data did not allow performing subgroup analysis based on type of open mesh and non-
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mesh techniques.
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DISCUSSION
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A systematic review and meta-analysis was performed to compare use of diathermy and scalpel for
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skin incision in patients undergoing open inguinal hernia repair. Overall, 9 studies, 4 RCTs and 5
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prospective cohort studies, enrolling a total of 830 patients were identified. The meta-analysis showed
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no difference between the diathermy and scalpel groups in terms of SSI, seroma, and VAS pain score
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at 6 hours, 12 hours, and 24 hours; however, the use of diathermy for skin incision was associated
289
with shorter incision time and lower risk of haematoma. The results remained consistent through
9
290
sensitivity analyses and separate analyses of randomised and non-randomised studies. Based on the
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Cochrane risk of bias tool and ROBINS-I tool, the quality of the available evidence was moderate.
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Although use of diathermy and scalpel for making skin incision in open inguinal hernia repair has not
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been investigated in previous reviews, use of diathermy and scalpel for skin incision in major
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abdominal surgery and any types of surgery have been investigated by some authors. Charoenkwan et
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al.17 found no difference in SSI, wound dehiscence, incision-related blood loss and incision time
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between the use of diathermy and scalpel in major abdominal operations. Moreover, Ly et al.18 in a
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meta-analysis including patients undergoing any types of surgery concluded that incisions made by
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diathermy are associated with shorter incision time and less incision-related blood loss compared with
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incisions made by scalpel with comparable risks of wound complications or postoperative pain. The
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results of current review is in agreement with the results from the above reviews17,18 in terms of SSI
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and postoperative pain. In terms of incision time and incision-related blood loss, our results are
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consistent with the results from Ly et al but in disagreement with the results from Charoenkwan et al.
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The difference in findings can be explained by the fact that the included studies in previous reviews
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were heterogeneous in terms of included population and type of surgical procedures including
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operations related to neck surgery, thoracic surgery, orthopaedic surgery, gynaecological surgery and
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major abdominal surgery. This is considered as a major limitation in the previous reviews as the
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anatomy of incision site in terms of underlying neurovascular structures and the length of incision
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required are variable in different procedures affecting the incision-related outcomes such as incision
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time, postoperative pain and wound complications. Therefore, in order to avoid the bias related to the
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aforementioned limitation, the use of diathermy and scalpel should only be compared in similar
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procedures.
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Experimental studies2-4 suggested increased risk of wound infections associated with use of diathermy
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for skin incision due to reduced tensile strength and greater zone of wound necrosis. However, the
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results of current study does not support the findings of the experimental studies as we found no
315
difference in SSI between the diathermy and scalpel groups. It has also been argued that use of
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diathermy is associated with lateral thermal spread resulting in a wider zone of tissue injury leading to
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accumulation of acute phase reactants hence more pain.19,20 The results of current study rejects this
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hypothesis as we found no difference in postoperative VAS pain score at 6 hours, 12 hours, and 24
319
hours. The shorter incision time found in the diathermy group in this study may be explained by the
320
fact that when scalpel is used for skin incision, achieving haemostasis may require several instrument
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exchanges with coagulation diathermy, increasing the incision time. Nevertheless, although incision
322
time may be important in operations that require long incisions, it may not be clinically significant in
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open inguinal hernia repair where the incision length is predominantly less than 10 cm.
10
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The results of this study should be interpreted in the context of some limitations. Among the included
325
studies, five had non-randomised design that are inevitably subject to selection bias. Although 9
326
studies were included in this study, most of the included studies included less than 100 patients;
327
therefore, type 2 error cannot be excluded. Unfortunately, the available data was not adequate to
328
perform trial sequential analysis to formally assess the likelihood of type 1 or 2 error in the meta-
329
analysis. Although postoperative pain and wound complications have been commonly investigated in
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the literature, long term outcomes including cosmetic and patient satisfaction outcomes are lacking;
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therefore, this study cannot make any conclusions regarding these outcomes which should be the
332
outcomes of interest in future studies. Finally, the reporting bias cannot be excluded in this study as
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formal assessment of publication bias was not possible due to less than 10 studies included in this
334
review.
335
CONCLUSIONS
336
There is no difference between the use of diathermy and scalpel for skin incision in patients
337
undergoing open inguinal hernia repair in terms of surgical site infection, seroma and postoperative
338
pain. Use of diathermy for skin incision may be associated with shorter incision time and may reduce
339
the risk of haematoma formation. Long term outcomes including cosmetic and patient satisfaction
340
outcomes are lacking and should be the outcomes of interest in future studies.
341
Conflict of interest
342
None declared.
343
Ethical approval
344
Not required.
345
Funding
346
This research received no specific grant from any funding agency in the public, commercial, or not-
347
for-profit sectors.
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Provenance and peer review
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Not commissioned, externally peer-reviewed
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inguinal hernia repair with polypropylene mesh: the randomized, double-blind, prospective
366
trial. Ann Surg 2001; 233: 26-33.
367
6. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, Clarke M,
368
Devereaux PJ, Kleijnen J, Moher D (2009) The PRISMA statement for reporting systematic
369
reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and
370
elaboration. BMJ 339:b2700
371
7. Higgins JP, Green S, editors. Chapter 8: Assessing risk of bias in included studies. In: Higgins
372
JP, Green S, editors. Cochrane handbook for systematic reviews of interventions. Version
373
5.1.0 (updated September March 2011). http://handbook-5-1.cochrane.org. Accessed 10
374
October 2018.
375
8. Gupta M, Soni S, Saini P. A prospective study of scalpel skin incision versus diathermy in
376
patients undergoing inguinal hernioplasty. J Evolution Med Dent Sci. 2017; 6(39):3136-3138.
377
9. Keluth S, Kenche J, P Swetana. A study comparing the results of diathermy incision versus
378
scalpel incision in patients undergoing inguinal hernioplasty. Indian Journal of Applied
379
Research 2016; 6; 2.
380
10. Shivagouda P, Gogeri BV, Godhi AS, Metgud SC. Prospective randomized control trial
381
comparing the efficacy of diathermy incision versus scalpel incision over skin in patients
382
undergoing inguinal hernia repair. Recent Research in Science and Technology 2010, 2(8):
383
44-47.
384
11. Dixon AR, Watkin DF. Electrosurgical skin incision versus conventional scalpel: a
385
prospective trial. Journal of the Royal College of Surgeons of Edinburgh 1990; 35(5):299–
386
301.
387
12. Rani MR, Kumar KV, Tamkeen SA, Hashmi SM. Comparison of surgical site infections
388
following use of diathermy and scalpel for making skin incisions in open inguinal hernia
389
repairs. Indian Journal of Applied Research. 2019;9;9.
12
390
13. Ragesh KV, Mahendran S, Siddarth M. Outcome of skin incision by cautery versus steel
391
scalpel in hernia surgery: a prospective cohort study at a tertiary medical college hospital in
392
South India. Int Surg J. 2017; 4(5):1521-1524.
393
14. Ansari M., Mishra S, Baskota, B. A comparative study of electrocautery versus cold scalpel
394
for skin incision in Inguinal Hernia Repair. Journal of Nepalgunj Medical College, 14(1), 14-
395
17.
396
15. Ali Q, Siddique K, Mirza S, Malik AZ. Comparison of superficial surgical site infection
397
following use of diathermy and scalpel for making skin incision in inguinal hernioplasty.
398
Niger J Clin Pract. 2009 Dec;12(4):371-4.
399
16. Chrysos E, Athanasakis E, Antonakakis S, Xynos E, Zoras O. A prospective study comparing
400
diathermy and scalpel incisions in tension-free inguinal hernioplasty. Am Surg. 2005
401
Apr;71(4):326-9.
402
17. Charoenkwan K, Iheozor-Ejiofor Z, Rerkasem K, Matovinovic E. Scalpel versus
403
electrosurgery for major abdominal incisions. Cochrane Database Syst Rev. 2017 Jun
404
14;6:CD005987.
405 406
18. Ly J, Mittal A, Windsor J. Systematic review and meta-analysis of cutting diathermy versus scalpel for skin incision. Br J Surg. 2012 May;99(5):613-20.
407
19. Johnson M, Gadacz TR, Pfeifer EA, Given KS, Gao X. Comparison of CO2 laser,
408
electrocautery, and scalpel incisions on acute-phase reactants in rat skin. Am Surg 1997; 63:
409
13–16.
410
20. Sutton PA, Awad S, Perkins AC, Lobo DN. Comparison of lateral thermal spread using
411
monopolar and bipolar diathermy, the Harmonic Scalpel and the ligasure. Br J Surg 2010; 97:
412
428–433.
413 414 415 416 417 418 419 420 421 422 423
13
424 425 426 427 428 429 430 431 432 433 434 435
Appendix I Search No
Search strategy†
#1
diathermy: TI,AB,KW
#2
MeSH descriptor: [electrosurgery] explode all trees
#3 #4
MeSH descriptor: [diathermy] explode all trees #1 OR #2 OR #3
#5
scalpel: TI,AB,KW
#6 #7 #8 #9 #11 #12
knife: TI,AB,KW #5 OR #6 MeSH descriptor: [inguinal hernia] explode all trees inguinal near 2 hernia: TI,AB,KW #8 OR #9 #4 AND #7 AND #11
† This search strategy was adopted for following databases: MEDLINE, EMBASE, CINAHL and the Cochrane Central Register of Controlled Trials (CENTRAL)
436
14
Table 1- Baseline characteristics of the included studies
Study
Country
Journal
Design
Included population
Type of open repair
Sample size
Total
Diathermy Group
Scalpel Group
Rani 2019 [12]
India
Indian Journal of Applied Research
Prospective cohort study
Patients undergoing open hernia repair
NR
100
50
50
Ragesh 2017 [13]
India
International Surgery Journal
Prospective cohort study
Patients undergoing open hernia repair
Lichtenstein
200
100
100
Gupta 2017 [8]
India
J Evolution Med Dent Sci
Randomised controlled trial
Patients undergoing open hernia repair
NR
80
40
40
Ansari 2016 [14]
Nepal
Journal of Nepalgunj Medical College
Prospective cohort study
Patients undergoing open hernia repair
NR
60
30
30
Keluth 2016 [9]
India
Indian Journal of Applied Research
Randomised controlled trial
Patients undergoing open hernia repair
Lichtenstein
60
30
30
Shivagouda 2010 [10]
India
Recent Research in Science and Technology
Randomised controlled trial
Patients undergoing open hernia repair
Lichtenstein
60
30
30
Ali 2009 [15]
Pakistan
Niger J Clin Pract
Prospective cohort study
Patients undergoing open hernia repair
NR
80
40
40
Chrysos 2005 [16]
Greek
Am Surg
Prospective cohort study
Patients undergoing open hernia repair
Lichtenstein
130
65
65
UK
J R Coll Surg Edinb
Randomised controlled trial
Patients undergoing open hernia repair
NR
60
30
30
Dixon 1990 [11] NR: not reported
Figure 1. Study flow diagram
(a)
(b)
Figure 2. Risk of bias summary and graph showing authors’ judgements about each risk of bias item for: a) Randomised trials b) Observational studies
a) Surgical site infection
b) Haematoma
c) Seroma
d) VAS pain score at 6 hours
e) VAS pain score at 12 hours
f) VAS pain score at 24 hours
g) Incision time
Figure 3. Forest plots of the comparisons of outcomes between the diathermy and scalpel groups: a) surgical site infection; b) Haematoma, c) Seroma; d) VAS pain score at 6 hours; e) VAS pain score at 12 hours; f) VAS pain score at 24 hours; g) Incision time
Highlights •
There is no difference between the use of diathermy and scalpel for skin incision in open inguinal hernia repair in terms of surgical site infection, seroma and postoperative pain.
•
Use of diathermy may be associated with shorter incision time
•
Use of diathermy may reduce the risk of haematoma formation.
•
Long term outcomes including cosmetic and patient satisfaction outcomes are lacking
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1
Author contribution Please specify the contribution of each author to the paper, e.g. study design, data collections, data analysis, writing. Others, who have contributed in other ways should be listed as contributors. Conception and design: AM, SH Data collection: SH, SH Analysis and interpretation: All authors Writing the article: All authors Critical revision of the article: All authors Final approval of the article: All authors Statistical analysis: SH, SH
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2
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DOI:
https://doi.org/10.1016/j.ijsu.2020.01.020
Reference:
IJSU 5227
To appear in:
International Journal of Surgery
Received Date: 21 November 2019 Accepted Date: 17 January 2020
Please cite this article as: Hajibandeh S, Hajibandeh S, Maw A, Diathermy versus scalpel for skin incision in patients undergoing open inguinal hernia repair: A systematic review and meta-analysis International Journal of Surgery, https://doi.org/10.1016/j.ijsu.2020.01.020. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
Diathermy versus scalpel for skin incision in patients undergoing open inguinal hernia repair: A systematic review and meta-analysis Shahab Hajibandeh,1*# Shahin Hajibandeh,2* Andrew Maw.1 1- Department of Colorectal and General Surgery, Glan Clwyd Hospital, Rhyl, UK 2- Department of General Surgery, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK
* Shahab Hajibandeh and Shahin Hajibandeh equally contributed to this paper and joined first authorship is proposed
# Corresponding author: Shahab Hajibandeh Address: Department of Colorectal and General Surgery, Glan Clwyd Hospital, Rhyl, Denbighshire, UK E-mail: [email protected] ; tel: +44 7766106423
Key words: scalpel; diathermy; inguinal hernia
There are no funding sources for this work, no conflicts of interest and no financial disclosures for all the authors.
1 2 3 4 5 6
8
Diathermy versus scalpel for skin incision in patients undergoing open inguinal hernia repair:
9
A systematic review and meta-analysis
7
10 11 12 13 14 15
Key words: scalpel; diathermy; inguinal hernia
16 17 18 19
There are no funding sources for this work, no conflicts of interest and no financial disclosures for all the authors.
20 21 22 23 24 25 26 27 28 29 30 31
1
32
ABSTRACT
33 34
Objectives: To compare outcomes of diathermy and scalpel for skin incision in patients undergoing open inguinal hernia repair.
35 36 37 38 39 40 41 42 43
Methods: We performed a systematic review in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement standards. We conducted a search of electronic information sources to identify all randomised controlled trials (RCTs) and observational studies comparing use of diathermy and scalpel for skin incision in patients undergoing inguinal hernia repair. Surgical site infection (SSI) was the primary outcome measure. Secondary outcome measures included haematoma, seroma, visual analogue scale (VAS) pain score at 6 hours, 12 hours, and 24 hours, and incision time. We used Cochrane risk of bias tool and ROBINS-I tool to assess the risk of bias of randomised and non-randomised studies. Fixed-effect model was applied to calculate pooled outcome data.
44 45 46 47 48 49 50 51 52 53 54 55 56 57 58
Results: We identified 9 studies, 4 randomised controlled trials and 5 prospective cohort studies, enrolling a total of 830 patients. Meta-analysis of RCTs showed no difference between the diathermy and scalpel groups in terms of surgical site infection (OR: 0.77, 95% CI 0.34, 1.75, P=0.53), seroma (OR: 0.86, 95% CI 0.29, 2.55, P=0.78), VAS pain score at 6 hours (MD: -0.10, 95% CI -0.31, 0.11, P=0.34), 12 hours (MD: -0.10, 95% CI -0.13, 0.33, P=0.40), and 24 hours (MD: 0.03, 95% CI -0.16, 0.21, P=0.79). Use of diathermy for skin incision was associated with shorter incision time (MD: 36.00, 95% CI -47.92, -24.08, P<0.00001) and lower risk of haematoma (OR: 0.14, 95% CI 0.03, 0.65, P=0.01). Meta-analysis of observational studies showed no difference between the diathermy and scalpel groups in terms of surgical site infection (OR: 0.87, 95% CI 0.54, 1.39, P=0.55), haematoma (OR 0.14, 95% CI 0.02-1.23, P = 0.08), seroma (OR: 0.86, 95% CI 0.29, 2.55, P=0.78), VAS pain score at 6 hours (MD: -0.10, 95% CI -0.44, 0.24, P=0.56), 12 hours (MD: -0.10, 95% CI 0.26, 0.46, P=0.58), and 24 hours (MD: 0.10, 95% CI -0.27, 0.47, P=0.59). Use of diathermy for skin incision was associated with shorter incision time (MD: -39.40, 95% CI -41.02, -37.78, P<0.00001). The results remained consistent through sensitivity analyses. The between-study heterogeneity was low and the quality of the available evidence was moderate.
59 60 61 62
Conclusions: There is no difference between use of diathermy and scalpel for skin incision in patients undergoing open inguinal hernia repair in terms of surgical site infection, seroma and postoperative pain. Use of diathermy for skin incision may be associated with shorter incision time and may reduce the risk of haematoma formation.
63 64 65 66 67 68 69 70 71 72 2
73
INTRODUCTION
74
Surgical skin incisions can be made with scalpel or cutting diathermy. Making incision using scalpel
75
involves cutting through skin using a sharp blade while cutting diathermy incises skin by generating
76
heat. An optimum technique for making skin incision should allow precise incision with minimal risk
77
of bleeding and surgical site infection (SSI). The potential advantages of diathermy use for making
78
skin incision may include incision-related blooding, and dry and rapid tissue separation.1 However, it
79
may be associated with collateral heat damage, impaired wound healing, excessive scarring and
80
potentially higher risk of SSI due to necrosis at the wound edges.2-4
81
Inguinal hernia repair is one of the most common general surgical procedures performed worldwide.
82
Although wound complications following inguinal hernia repair is uncommon, they are associated
83
with increased risk of hernia recurrence and consequent morbidity.5 Therefore, minimising the risk of
84
wound complications following inguinal hernia repair is crucial. Whether the technique used for
85
making skin incision in patients undergoing inguinal hernia repair can influence the risk of wound
86
complications remains unknown. The use of scalpel versus diathermy for making skin incision in
87
open inguinal hernia repair have been compared in some studies making performing a systematic
88
review worthwhile.
89
In this study, we aimed to perform a systematic review and meta-analysis to compare the outcomes of
90
diathermy and scalpel for skin incision in patients undergoing open inguinal hernia repair.
91
METHODS
92
This review was performed according to a predefined protocol (PROSPERO registration number:
93
CRD42019157996) in compliance with the Preferred Reporting Items for Systematic Reviews and
94
Meta-Analyses (PRISMA) statement standards6 and AMSTAR (Assessing the methodological quality
95
of systematic reviews) Guidelines.
96 97
Criteria for considering studies for this review
98
Types of studies
99
All randomised controlled trials (RCTs) and observational studies comparing diathermy and scalpel
100
for skin incision in patients undergoing open inguinal hernia repair.
101
Types of participants
102
The participants of interest in this study were patients of any age and gender undergoing open
103
inguinal hernia repair. The list of open inguinal hernia repair techniques of interest was not exhaustive
104
and included open mesh repair techniques (Lichtenstein, plug and patch, Prolene mesh system, Kugel, 3
105
Stoppa, Trabucco, Wantz, or Robbins techniques) or open non-mesh techniques (Shouldice, Bassini,
106
McVay, Halste, Darn, or Desarda techniques).
107
Types of interventions
108
The use of diathermy for skin incision was considered as intervention of interest and the use of a
109
scalpel for skin incision was considered as comparison of interest.
110
Types of outcome measures
111
Primary Outcome
112 113
•
Surgical site infection (SSI)
Secondary outcomes
114
•
Haematoma
115
•
Seroma
116
•
Visual analogue scale (VAS) pain score at 6 hours, 12 hours, and 24 hours postoperatively
117
•
Incision time
118
Search methods for identification of studies
119
Electronic searches
120
Two authors independently searched the following electronic databases: MEDLINE, EMBASE,
121
Scopus, CINAHL, and the Cochrane Central Register of Controlled Trials (CENTRAL). The last
122
search was run on 10 September 2019. Thesaurus headings, search operators and limits in each of the
123
above databases were adapted accordingly. The literature search strategy is outlined in Appendix I. In
124
addition,
125
(http://apps.who.int/trialsearch/), ClinicalTrials.gov (http://clinicaltrials.gov/) and ISRCTN Register
126
(http://www.isrctn.com/) were searched for details of ongoing and unpublished studies. No language
127
restrictions were applied in our search strategies. The bibliographic lists of relevant articles and
128
reviews were also searched for further potentially eligible trials.
129
Data collection and analysis
130
Selection of studies
131
The title and abstract of articles identified from the literature searches were assessed independently by
132
two authors. The full-texts of relevant reports were retrieved and those articles that met the eligibility
133
criteria of our review were selected. Any discrepancies in study selection were resolved by discussion
134
between the authors. An independent third author was consulted in the event of disagreement.
135
Data extraction and management
World
Health
Organization
International
Clinical
Trials
Registry
4
136
We created an electronic data extraction spreadsheet in line with Cochrane’s data collection form for
137
intervention reviews. The spreadsheet was pilot-tested in randomly selected articles and was adjusted
138
accordingly. It included study-related data (first author, year of publication, country of origin of the
139
corresponding author, journal in which the study was published, study design, study size, clinical
140
condition of the study participants, type of intervention and comparison), baseline demographic and
141
clinical information of the included populations, and outcome data. Two authors independently
142
collected and recorded data in the data extraction spreadsheet and disagreements were resolved by
143
discussion. If no agreement could be reached, a third author was consulted.
144
Assessment of risk of bias in included studies
145
The Cochrane tool that categorises studies into low, unclear, and high risk of bias in terms of selection
146
bias, detection bias, performance bias, reporting bias, attrition bias, and other sources of bias was used
147
for methodological quality assessment of RCTs. The Risk Of Bias In Non-randomized Studies – of
148
Interventions (ROBINS-I) assessment tool was used for methodological quality assessment of
149
observational studies in terms of the following domains: bias due to confounding, bias in selection of
150
participants into the study, bias in classification of interventions, bias due to deviations from intended
151
intervention, bias due to missing data, bias in measurement of outcomes, and bias in selection of the
152
reported result. Methodological quality assessment was performed by two independent authors and in
153
case of disagreements a third independent author was consulted.
154
Data synthesis and statistical analyses
155
The odds ratio (OR) and mean difference (MD) were calculated as summary measures for
156
dichotomous and continuous outcome variables, respectively. An individual hernia was considered as
157
the unit of analysis. Information about dropouts, withdrawals, and other missing data were recorded,
158
and if not reported, the study authors were contacted where possible. The analyses were based on
159
intention to- treat data from the individual clinical studies. We used the Review Manager 5.3
160
(RevMan, Version 5.3. Copenhagen, 2014) software for data synthesis.6 Random or fixed effects
161
modelling were applied as appropriate for analyses; random effects models were used if significant
162
heterogeneity was noted among the studies. The Cochran Q test (χ2) was used to evaluate
163
heterogeneity and I2 was reported to quantify it. In terms of interpretation of I2, we considered I2 of 0-
164
50% as low heterogeneity, 50-75% as moderate heterogeneity and 75-100% as high heterogeneity.
165
We planned to construct funnel plots and evaluate their symmetry to visually assess publication bias
166
for outcomes reported by at least 10 studies where possible.
167
Sensitivity and subgroup analyses
168
The robustness of the primary analyses were evaluated further by additional analyses for the outcomes
169
that were reported by at least 4 studies. First, the risk ratio (RR) and risk difference (RD) were 5
170
calculated instead of OR for dichotomous variables. Then, the primary analyses were repeated using
171
the random effects and fixed effect models. Furthermore, in order to determine the influence of each
172
study on the overall effect size and heterogeneity, each study was eliminated at a time and the analysis
173
was repeated. We planned to perform separate analyses for RCTs with low risk of selection bias in
174
terms of allocation concealment and randomisation. Where possible, we aimed to perform subgroup
175
analysis based on type of open hernia repair (mesh vs non-mesh techniques).
176
RESULTS
177
Results of the search
178
Overall, 98 articles were identified after applying the search strategy in the aforementioned databases.
179
Among the studies that were identified through search of electronic databases, 89 articles were not
180
relevant to the topic of this study and were excluded directly. The remaining 9 studies8-16 were
181
relevant to the topic of this study and, after assessing their full-texts, all were considered eligible for
182
inclusion in this study. These included 4 RCTs8-11 and 5 prospective cohort studies12-16 enrolling a
183
total of 830 patients with 830 hernias. All studies included patients undergoing open inguinal hernia
184
repair. Overall, 415 patients with 415 hernias were included in the diathermy group and 415 patients
185
with 415 hernias were included in the scalpel group. The literature search flow chart and baseline
186
characteristics of the included studies are demonstrated in Figure 1 and Table 1, respectively.
187
Risk of bias in included studies
188
The summary and results of methodological quality assessment of the 4 RCTs8-11 and 5 prospective
189
cohort studies12-16 are demonstrated graphically in Figure 2.
190
Outcome synthesis
191
Surgical site infection
192
All studies. SSI was reported in nine studies,8-16 including 830 hernia repairs (Figure 3). There was no
193
difference in the risk of SSI between the diathermy and scalpel groups (OR 0.84, 95% CI 0.56-1.27, P
194
= 0.41). A low level of heterogeneity among the studies existed (I2 = 0%, P = 1.0).
195
Randomised controlled trials. SSI was reported in four RCTs,8-11 including 260 hernia repairs (Figure
196
3). There was no significant difference in the risk of SSI between the diathermy and scalpel groups
197
(OR 0.77, 95% CI 0.34-1.75, P = 0.53). A low level of heterogeneity among the studies existed (I2 =
198
0%, P = 0.95).
199
Observational studies. SSI was reported in five observational studies,12-16 including 570 hernia repairs
200
(Figure 3). There was no significant difference in the risk of SSI between the diathermy and scalpel 6
201
groups (OR 0.87, 95% CI 0.54-1.39, P = 0.55). A low level of heterogeneity among the studies
202
existed (I2 = 0%, P = 0.92).
203
Haematoma
204
All studies. Haematoma was reported in three studies,9,10,14 including 180 hernia repairs (Figure 3).
205
Use of diathermy was associated with a lower risk of haematoma compared with use of scalpel (OR
206
0.14, 95% CI 0.04-1.49, P = 0.002). A low level of heterogeneity among the studies existed (I2 = 0%,
207
P = 1.00).
208
Randomised controlled trials. Haematoma was reported in two RCTs,9,10 including 120 hernia repairs
209
(Figure 3). Use of diathermy was associated with a lower risk of haematoma compared with use of
210
scalpel (OR 0.14, 95% CI 0.03-0.65, P = 0.01). A low level of heterogeneity among the studies
211
existed (I2 = 0%, P = 1.00).
212
Observational studies. Haematoma was reported in one observational study,14 including 60 hernia
213
repairs (Figure 3). There was no difference in the risk of haematoma between the diathermy and
214
scalpel groups (OR 0.14, 95% CI 0.02-1.23, P = 0.08).
215
Seroma
216
All studies. Seroma was reported in two studies,10,14 including 120 hernia repairs (Figure 3). There
217
was no difference in the risk of seroma between the diathermy and scalpel groups (OR 0.86, 95% CI
218
0.40-1.85, P = 0.69). A low level of heterogeneity among the studies existed (I2 = 0%, P = 1.00).
219
Randomised controlled trials. Seroma was reported in one RCT,10 including 60 hernia repairs (Figure
220
3). There was no difference in the risk of seroma between the diathermy and scalpel groups (OR 0.86,
221
95% CI 0.29-2.55, P = 0.78).
222
Observational studies. Seroma was reported in one observational study,14 including 60 hernia repairs
223
(Figure 3). There was no difference in the risk of seroma between the diathermy and scalpel groups
224
(OR 0.86, 95% CI 0.29-2.55, P = 0.78).
225
VAS pain score at 6 hours
226
All studies. VAS pain score at 6 hours was reported in three studies,8,10,14 including 200 hernia repairs
227
(Figure 3). There was no difference in VAS pain score at 6 hours between the diathermy and scalpel
228
groups (MD -0.10, 95% CI -0.28-0.08, P = 0.27). A low level of heterogeneity among the studies
229
existed (I2 = 0%, P = 1.00).
7
230
Randomised controlled trials. VAS pain score at 6 hours was reported in two RCTs,8,10 including 140
231
hernia repairs (Figure 3). There was no difference in VAS pain score at 6 hours between the
232
diathermy and scalpel groups (MD -0.10, 95% CI -0.31-0.11, P = 0.34). A low level of heterogeneity
233
among the studies existed (I2 = 0%, P = 1.00).
234
Observational studies. VAS pain score at 6 hours was reported in one observational study,14 including
235
60 hernia repairs (Figure 3). There was no difference in VAS pain score at 6 hours between the
236
diathermy and scalpel groups (MD -0.10, 95% CI -0.44-0.24, P = 0.56).
237
VAS pain score at 12 hours
238
All studies. VAS pain score at 12 hours was reported in three studies,8,10,14 including 200 hernia
239
repairs (Figure 3). There was no difference in VAS pain score at 12 hours between the diathermy and
240
scalpel groups (MD 0.10, 95% CI -0.10-0.30, P = 0.32). A low level of heterogeneity among the
241
studies existed (I2 = 0%, P = 1.00).
242
Randomised controlled trials. VAS pain score at 12 hours was reported in two RCTs,8,10 including
243
140 hernia repairs (Figure 3). There was no difference in VAS pain score at 12 hours between the
244
diathermy and scalpel groups (MD 0.10, 95% CI -0.13-0.33, P = 0.40). A low level of heterogeneity
245
among the studies existed (I2 = 0%, P = 1.00).
246
Observational studies. VAS pain score at 12 hours was reported in one observational study,14
247
including 60 hernia repairs (Figure 3). There was no difference in VAS pain score at 12 hours
248
between the diathermy and scalpel groups (MD 0.10, 95% CI -0.26-0.46, P = 0.58).
249
VAS pain score at 24 hours
250
All studies. VAS pain score at 24 hours was reported in three studies,8,10,14 including 200 hernia
251
repairs (Figure 3). There was no difference in VAS pain score at 24 hours between the diathermy and
252
scalpel groups (MD 0.04, 95% CI -0.13-0.21, P = 0.63). A low level of heterogeneity among the
253
studies existed (I2 = 0%, P = 0.85).
254
Randomised controlled trials. VAS pain score at 24 hours was reported in two RCTs,8,10 including
255
140 hernia repairs (Figure 3). There was no difference in VAS pain score at 24 hours between the
256
diathermy and scalpel groups (MD 0.03, 95% CI -0.16-0.21, P = 0.79). A low level of heterogeneity
257
among the studies existed (I2 = 0%, P = 0.65).
258
Observational studies. VAS pain score at 24 hours was reported in one observational study,14
259
including 60 hernia repairs (Figure 3). There was no difference in VAS pain score at 24 hours
260
between the diathermy and scalpel groups (MD 0.10, 95% CI -0.27-0.47, P = 0.59). 8
261
Incision time
262
All studies. Incision time was reported in two studies,11,14 including 120 hernia repairs (Figure 3). Use
263
of diathermy was associated with shorter incision time compared with use of scalpel (MD -39.34,
264
95% CI -40.94 - -37.73, P < 0.00001). A low level of heterogeneity among the studies existed (I2 =
265
0%, P =0.58).
266
Randomised controlled trials. Incision time was reported in one RCT,11 including 60 hernia repairs
267
(Figure 3). Use of diathermy was associated with shorter incision time compared with use of scalpel
268
(MD -36.00, 95% CI -47.92 - -24.08, P < 0.00001).
269
Observational studies. Incision time was reported in one observational study,14 including 60 hernia
270
repairs (Figure 3). Use of diathermy was associated with shorter incision time compared with use of
271
scalpel (MD -39.40, 95% CI -41.02 - -37.78, P < 0.00001).
272
Additional analyses
273
Sensitivity analyses
274
Sensitivity analyses were performed for SSI that was reported by more than four studies. Removing
275
one study at a time did not change the direction of the effect size and the overall heterogeneity. The
276
direction of the effect size remained unchanged when ORs, RRs or RDs were calculated separately.
277
The use of random effects or fixed effect models did not affect the direction of the effect size.
278
Separate analyses for studies with low or moderate risk of bias did not affect the direction of the effect
279
size.
280
Subgroup analysis
281
The available data did not allow performing subgroup analysis based on type of open mesh and non-
282
mesh techniques.
283
DISCUSSION
284
A systematic review and meta-analysis was performed to compare use of diathermy and scalpel for
285
skin incision in patients undergoing open inguinal hernia repair. Overall, 9 studies, 4 RCTs and 5
286
prospective cohort studies, enrolling a total of 830 patients were identified. The meta-analysis showed
287
no difference between the diathermy and scalpel groups in terms of SSI, seroma, and VAS pain score
288
at 6 hours, 12 hours, and 24 hours; however, the use of diathermy for skin incision was associated
289
with shorter incision time and lower risk of haematoma. The results remained consistent through
9
290
sensitivity analyses and separate analyses of randomised and non-randomised studies. Based on the
291
Cochrane risk of bias tool and ROBINS-I tool, the quality of the available evidence was moderate.
292
Although use of diathermy and scalpel for making skin incision in open inguinal hernia repair has not
293
been investigated in previous reviews, use of diathermy and scalpel for skin incision in major
294
abdominal surgery and any types of surgery have been investigated by some authors. Charoenkwan et
295
al.17 found no difference in SSI, wound dehiscence, incision-related blood loss and incision time
296
between the use of diathermy and scalpel in major abdominal operations. Moreover, Ly et al.18 in a
297
meta-analysis including patients undergoing any types of surgery concluded that incisions made by
298
diathermy are associated with shorter incision time and less incision-related blood loss compared with
299
incisions made by scalpel with comparable risks of wound complications or postoperative pain. The
300
results of current review is in agreement with the results from the above reviews17,18 in terms of SSI
301
and postoperative pain. In terms of incision time and incision-related blood loss, our results are
302
consistent with the results from Ly et al but in disagreement with the results from Charoenkwan et al.
303
The difference in findings can be explained by the fact that the included studies in previous reviews
304
were heterogeneous in terms of included population and type of surgical procedures including
305
operations related to neck surgery, thoracic surgery, orthopaedic surgery, gynaecological surgery and
306
major abdominal surgery. This is considered as a major limitation in the previous reviews as the
307
anatomy of incision site in terms of underlying neurovascular structures and the length of incision
308
required are variable in different procedures affecting the incision-related outcomes such as incision
309
time, postoperative pain and wound complications. Therefore, in order to avoid the bias related to the
310
aforementioned limitation, the use of diathermy and scalpel should only be compared in similar
311
procedures.
312
Experimental studies2-4 suggested increased risk of wound infections associated with use of diathermy
313
for skin incision due to reduced tensile strength and greater zone of wound necrosis. However, the
314
results of current study does not support the findings of the experimental studies as we found no
315
difference in SSI between the diathermy and scalpel groups. It has also been argued that use of
316
diathermy is associated with lateral thermal spread resulting in a wider zone of tissue injury leading to
317
accumulation of acute phase reactants hence more pain.19,20 The results of current study rejects this
318
hypothesis as we found no difference in postoperative VAS pain score at 6 hours, 12 hours, and 24
319
hours. The shorter incision time found in the diathermy group in this study may be explained by the
320
fact that when scalpel is used for skin incision, achieving haemostasis may require several instrument
321
exchanges with coagulation diathermy, increasing the incision time. Nevertheless, although incision
322
time may be important in operations that require long incisions, it may not be clinically significant in
323
open inguinal hernia repair where the incision length is predominantly less than 10 cm.
10
324
The results of this study should be interpreted in the context of some limitations. Among the included
325
studies, five had non-randomised design that are inevitably subject to selection bias. Although 9
326
studies were included in this study, most of the included studies included less than 100 patients;
327
therefore, type 2 error cannot be excluded. Unfortunately, the available data was not adequate to
328
perform trial sequential analysis to formally assess the likelihood of type 1 or 2 error in the meta-
329
analysis. Although postoperative pain and wound complications have been commonly investigated in
330
the literature, long term outcomes including cosmetic and patient satisfaction outcomes are lacking;
331
therefore, this study cannot make any conclusions regarding these outcomes which should be the
332
outcomes of interest in future studies. Finally, the reporting bias cannot be excluded in this study as
333
formal assessment of publication bias was not possible due to less than 10 studies included in this
334
review.
335
CONCLUSIONS
336
There is no difference between the use of diathermy and scalpel for skin incision in patients
337
undergoing open inguinal hernia repair in terms of surgical site infection, seroma and postoperative
338
pain. Use of diathermy for skin incision may be associated with shorter incision time and may reduce
339
the risk of haematoma formation. Long term outcomes including cosmetic and patient satisfaction
340
outcomes are lacking and should be the outcomes of interest in future studies.
341
Conflict of interest
342
None declared.
343
Ethical approval
344
Not required.
345
Funding
346
This research received no specific grant from any funding agency in the public, commercial, or not-
347
for-profit sectors.
348
Provenance and peer review
349
Not commissioned, externally peer-reviewed
350 351
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352
1. Soderstrom R. Principles of electrosurgery as applied to gynecology. In: Rock JA, Jones HW
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III editor(s). Te Linde’s Operative Gynecology. 9th Edition. Philadelphia (PA): Lippincott
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Williams & Wilkins, 2003:291–308.
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inguinal hernia repair with polypropylene mesh: the randomized, double-blind, prospective
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13. Ragesh KV, Mahendran S, Siddarth M. Outcome of skin incision by cautery versus steel
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Appendix I Search No
Search strategy†
#1
diathermy: TI,AB,KW
#2
MeSH descriptor: [electrosurgery] explode all trees
#3 #4
MeSH descriptor: [diathermy] explode all trees #1 OR #2 OR #3
#5
scalpel: TI,AB,KW
#6 #7 #8 #9 #11 #12
knife: TI,AB,KW #5 OR #6 MeSH descriptor: [inguinal hernia] explode all trees inguinal near 2 hernia: TI,AB,KW #8 OR #9 #4 AND #7 AND #11
† This search strategy was adopted for following databases: MEDLINE, EMBASE, CINAHL and the Cochrane Central Register of Controlled Trials (CENTRAL)
436
14
Table 1- Baseline characteristics of the included studies
Study
Country
Journal
Design
Included population
Type of open repair
Sample size
Total
Diathermy Group
Scalpel Group
Rani 2019 [12]
India
Indian Journal of Applied Research
Prospective cohort study
Patients undergoing open hernia repair
NR
100
50
50
Ragesh 2017 [13]
India
International Surgery Journal
Prospective cohort study
Patients undergoing open hernia repair
Lichtenstein
200
100
100
Gupta 2017 [8]
India
J Evolution Med Dent Sci
Randomised controlled trial
Patients undergoing open hernia repair
NR
80
40
40
Ansari 2016 [14]
Nepal
Journal of Nepalgunj Medical College
Prospective cohort study
Patients undergoing open hernia repair
NR
60
30
30
Keluth 2016 [9]
India
Indian Journal of Applied Research
Randomised controlled trial
Patients undergoing open hernia repair
Lichtenstein
60
30
30
Shivagouda 2010 [10]
India
Recent Research in Science and Technology
Randomised controlled trial
Patients undergoing open hernia repair
Lichtenstein
60
30
30
Ali 2009 [15]
Pakistan
Niger J Clin Pract
Prospective cohort study
Patients undergoing open hernia repair
NR
80
40
40
Chrysos 2005 [16]
Greek
Am Surg
Prospective cohort study
Patients undergoing open hernia repair
Lichtenstein
130
65
65
UK
J R Coll Surg Edinb
Randomised controlled trial
Patients undergoing open hernia repair
NR
60
30
30
Dixon 1990 [11] NR: not reported
Figure 1. Study flow diagram
(a)
(b)
Figure 2. Risk of bias summary and graph showing authors’ judgements about each risk of bias item for: a) Randomised trials b) Observational studies
a) Surgical site infection
b) Haematoma
c) Seroma
d) VAS pain score at 6 hours
e) VAS pain score at 12 hours
f) VAS pain score at 24 hours
g) Incision time
Figure 3. Forest plots of the comparisons of outcomes between the diathermy and scalpel groups: a) surgical site infection; b) Haematoma, c) Seroma; d) VAS pain score at 6 hours; e) VAS pain score at 12 hours; f) VAS pain score at 24 hours; g) Incision time
Highlights •
There is no difference between the use of diathermy and scalpel for skin incision in open inguinal hernia repair in terms of surgical site infection, seroma and postoperative pain.
•
Use of diathermy may be associated with shorter incision time
•
Use of diathermy may reduce the risk of haematoma formation.
•
Long term outcomes including cosmetic and patient satisfaction outcomes are lacking
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Author contribution Please specify the contribution of each author to the paper, e.g. study design, data collections, data analysis, writing. Others, who have contributed in other ways should be listed as contributors. Conception and design: AM, SH Data collection: SH, SH Analysis and interpretation: All authors Writing the article: All authors Critical revision of the article: All authors Final approval of the article: All authors Statistical analysis: SH, SH
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