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. 2024 Mar 6;2024(3):CD015470. doi: 10.1002/14651858.CD015470

Open versus laparoscopic repair for paediatric inguinal hernia

Julian L Muff 1, Fabian Lunger 2, Katrin Probyn 3, Elise Cogo 3, Stefan Holland-Cunz 1, Raphael N Vuille-dit-Bille 1,✉
Editor: Cochrane Colorectal Group
PMCID: PMC10915463

Objectives

This is a protocol for a Cochrane Review (intervention). The objectives are as follows:

To compare the efficacy and safety of open versus laparoscopic inguinal hernia repair in children.

Background

Description of the condition

Paediatric inguinal hernia is an inguinal or inguinoscrotal abnormality due to failure of closure of the processus vaginalis (Kapur 1998). Most paediatric inguinal hernias are indirect hernias (Clarke 2010). The reported cumulative incidence of paediatric inguinal hernia from birth to 15 years is 6.6% in boys with a peak at 0 years and 0.7% in girls with a peak at five years (Chang 2016). A patent processus vaginalis, which is more common in preterm infants, represents a risk factor for developing an inguinal hernia (Brandt 2008). This leads to higher reported incidences of inguinal hernias in preterm infants, decreasing as children age (Chang 2016).

Inguinal hernia reflects one of the most prevalent paediatric conditions requiring surgical treatment (Fujiogi 2019). Intra‐abdominal organs (e.g. bowel, ovaries) may prolapse into the hernia with the risk of incarceration and subsequent strangulation (Abdulhai 2017; Chang 2016). The estimated incarceration rate is around 12% in infants and young children with an inguinal hernia (Zamakhshary 2008). Therefore, elective repair is recommended in all cases (Morini 2022). The risk of a metachronous contralateral inguinal hernia is about 6% following hernia repair, with female sex and open processus vaginalis being risk factors (Wenk 2015). Data on chronic groin pain in children following surgical treatment of inguinal hernia are sparse and of low certainty. In one meta‐analysis of 1153 inguinal hernia repairs in adolescents, including both open and laparoscopic sutured repair techniques, the rate of chronic pain ranged from 0% to 11%, considerably lower than the rates observed in adult hernia repairs (Reistrup 2023).

Description of the intervention

Paediatric inguinal hernias can be repaired by the open technique or laparoscopic technique. In adults, inguinal hernia surgery typically involves mesh reinforcement, which can significantly reduce the hernia recurrence rate without increasing the risk of chronic pain (Stabilini 2023). However, the evidence for this technique in children is unclear. Due to concerns about implanting a non‐absorbable foreign body in young, still‐growing individuals, the use of mesh is normally avoided. One systematic review of non‐mesh repairs in adolescents reported a recurrence rate of 1.6% after open repairs and 1.9% after laparoscopic repairs (Reistrup 2023), suggesting lower recurrence rates after both repair types compared with adults (Lockhart 2018).

Open procedure

Open inguinal hernia repair involves the transection and ligation of the hernia sac; in males, it is necessary to first separate the patent processus vaginalis from the testicular vessels and the vas deferens (Potts 1950). Reported advantages of open surgery include the possibility of avoiding general anaesthesia (Lambertz 2014), and a potentially shorter operative time (Koivusalo 2009). One disadvantage may be a less satisfactory wound cosmesis (Chan 2005).

Laparoscopic procedure

The laparoscopic procedure was first performed in 1993 and subsequently reported by Montupet and colleagues in 1999 (Montupet 1999). Laparoscopic inguinal hernia repair involves insertion of a camera port (typically at the belly button) and either intra‐ or extracorporeal closing of the open processus vaginalis. The intra‐corporeal method uses an intra‐corporeal suture with the help of three ports, while extra‐corporeal closing uses a suture that is passed over two needles, and the knot is tied manually outside the patient without the need for an additional port (Maat 2021). Reported advantages of laparoscopic repair are lower rates of major complications (i.e. injuries to vas deferens, testicular vessels, or both; Feng 2015; Liu 2020), excellent wound cosmesis (Shalaby 2012), and a better visualisation of the inguinal region and therefore the possibility of repairing the contralateral side through the same access if needed (Kantor 2019). One disadvantage is the risk of penetrating trauma due to insertion of the trocars (Krishnakumar 2009).

How the intervention might work

Available evidence in children suggests that the laparoscopic approach for inguinal hernia repair might result in lower rates of major postoperative complications and a better wound cosmesis compared to the open procedure (Feng 2015; Liu 2020; Shalaby 2012). Furthermore, the laparoscopic approach may enhance visualisation of the inguinal region (Kantor 2019), with a shorter operative time in bilateral inguinal hernia repair (Liu 2020). In children, the open approach is more common; however, the laparoscopic approach is growing in popularity (Dreuning 2019). Consequently, a thorough investigation and comparison of both methods is warranted.

Why it is important to do this review

Systematic reviews on this topic published between 2020 and 2022 included different numbers of randomised controlled trials (RCTs; from four to 13), although the most recent RCT was published in 2017 (Gause 2017), and the reviews had similar study selection criteria (Bada‐Bosch 2022; Huang 2022; Liu 2020; Mahmood 2020; Zhao 2022). Therefore, it seems that the available evidence is based on different interpretations or calculations of the same RCTs. There is a need for a high‐quality systematic review with meta‐analyses to evaluate the open approach versus the laparoscopic approach for inguinal hernia repair in children.

Objectives

To compare the efficacy and safety of open versus laparoscopic inguinal hernia repair in children.

Methods

Criteria for considering studies for this review

Types of studies

We will consider only RCTs for this review, irrespective of their publication status and language. Quasi‐RCTs are ineligible.

Types of participants

We will include children (aged under 18 years) of any sex and race with a diagnosis of unilateral or bilateral inguinal hernia. Accepted methods of diagnosing unilateral or bilateral inguinal hernia are clinical exam, photo documentation by parents/guardians, ultrasound, or intraoperative detection (of contralateral hernia).

If a study includes both eligible and ineligible participants, we will include it if there are separate data for the eligible subset. If data are not presented separately, we will first contact the authors to request the data. If we cannot obtain separate data from the publication or from the study authors, we will exclude the study.

Types of interventions

We will assess any type of mesh‐free open inguinal hernia repair versus any type of mesh‐free laparoscopic inguinal hernia repair in children. We will include elective and acute inguinal hernia repairs. We will only include sutured repairs. We will exclude inguinal hernia repairs with the implantation of a mesh. We will consider conversion from laparoscopic to open procedure as an intraoperative complication of laparoscopic repair. Converted repairs will be handled in an intention‐to‐treat manner.

Types of outcome measures

We will assess efficacy and harm outcomes. Primary and secondary outcomes are not intended as inclusion criteria for studies. If more than one scale is measured/reported for the same outcome, we will extract all scales and only select one for the analysis, prioritising validated scales.

Primary outcomes

Our primary outcome is recurrence, assessed by clinical examination or verified by diagnostic imaging. We will consider both repaired and unrepaired recurrences. If a study reports recurrence rates of the same cohort multiple times, we will meta‐analyse the data reported at longest follow‐up. If a study reports hernia recurrence more than once for the same participant, we will count only one event.

Secondary outcomes

  • Intraoperative complications, defined as any deviation from the ideal intraoperative course occurring between skin incision and skin closure (Dell‐Kuster 2020)

    • Intraoperative injury of surrounding structures, measured as a dichotomous outcome (yes/no). If available, we will list details of injury per group.

    • Conversion (from laparoscopic to open procedure), measured as a dichotomous outcome (yes/no)

  • Complications according to Clavien‐Dindo within 30 days after the operation. If a study reports the same complication more than once for the same participant, we will count only one event. We will subdivide complications into the following grades (Dindo 2004).

    • Grade 1 to 2

    • Grade 3a

    • Grade 3b to 4

    • Grade 5 (death)

  • Postoperative acute pain, defined as acute pain immediately after surgery and within 24 hours, seven days, and 30 days after surgery. We will measure acute pain as a dichotomous outcome (yes/no per self‐report) or as a continuous outcome of pain intensity measured on a visual analogue scale (VAS) or other validated scale. If studies use different pain assessment methods (dichotomous and continuous), we will analyse them separately. If studies use different time points, we will report measurements that come as close to our set time points as possible.

  • Postoperative chronic pain, defined as pain persisting for more than six months after surgery (Alfieri 2011). We will analyse chronic pain as a dichotomous outcome (yes/no per self‐report) or as a continuous outcome of pain intensity measured on a VAS or other validated scale. If studies use different pain assessment methods (dichotomous and continuous), we will analyse them separately.

Search methods for identification of studies

We will search for relevant published and ongoing studies regardless of language.

Electronic searches

An experienced medical Information Specialist (EC) developed all search strategies in co‐operation with experts in the field. We will search the following databases.

  • Cochrane Central Register of Controlled Trials (CENTRAL; 1993 to present), in the Cochrane Library

  • MEDLINE via Ovid (1993 to present; Appendix 1)

  • Embase via Ovid (1993 to present)

As the first laparoscopic repair of paediatric inguinal hernia was conducted in 1993 (Montupet 1999), we will search for studies published from that year.

We will also perform supplemental searches of the following ongoing trials registries.

  • World Health Organization (WHO) International Clinical Trials Registry Platform (apps.who.int/trialsearch)

  • US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (clinicaltrials.gov)

  • ISRCTN registry (www.isrctn.com)

The terms we will use to search any sources other than bibliographic databases are (plus variants): paediatric + laparoscop* + inguinal + herni*.

Searching other resources

We will screen the reference lists of all included studies and related systematic reviews for additional references. We will search for errata and retractions from eligible studies on PubMed (pubmed.ncbi.nlm.nih.gov/).

Data collection and analysis

Selection of studies

Using Covidence software (Covidence), two review authors (JLM and FL) will independently screen the titles and abstracts of all citations identified in the search and eliminate those that are clearly irrelevant. We will obtain the full‐text reports of potentially eligible studies, and the same two review authors (JLM and FL) will assess them against our eligibility criteria. A third reviewer (RNV) will resolve any disagreements.

Data extraction and management

We will use a standard data collection form that has been piloted on at least one study in the review. Two review authors (JLM and FL) will independently extract the study characteristics and outcome data from the included studies. We will resolve any disagreement through discussion and subsequent consensus or by involving a third review author (RNV).

Data of interest include the following.

  • Study characteristics: study design and setting

  • Characteristics of participants: inclusion/exclusion criteria, age, sex

  • Details of the interventions

  • Assessed outcomes

  • Funding sources and stated conflicts of interest

Assessment of risk of bias in included studies

Three review authors (JLM, FL, KP) will independently assess the risk of bias for each included study using the updated Cochrane risk of bias tool (RoB 2; Sterne 2019). We will use the RoB 2 excel tool to implement the assessment. We will resolve any disagreement by discussion or by involving an additional review author (RNV). We will assess risk of bias for the outcome measures and time points selected for the summary of findings tables (Summary of findings and assessment of the certainty of the evidence). We will assess the effect of assignment to intervention at baseline (the intention‐to‐treat effect), regardless of whether the interventions were received as intended.

RoB 2 covers the following domains.

  • Risk of bias arising from the randomisation process

  • Risk of bias due to deviations from intended interventions

  • Risk of bias due to missing outcome data

  • Risk of bias in measurement of the outcome

  • Risk of bias in selection of the reported result

  • Overall risk of bias based on the assessments in the five domains

The response options to the signalling questions are 'yes', 'probably yes', 'probably no', 'no', and 'no information'. A risk of bias judgement arising from each domain is generated by an algorithm, based on answers to the signalling questions. Judgements can be 'low risk of bias,' 'some concerns', or 'high risk of bias'. We will judge the overall risk of bias as follows (Higgins 2023).

  • Low risk: all domains at low risk

  • Some concerns: at least one domain with some concerns and no domain at high risk

  • High risk: at least one domain considered at high risk, or several domains with some concerns

For cluster‐RCTs, we will also assess and report the risk of bias associated with an additional domain: timing of identification or recruitment of participants in a cluster.

If any risk of bias judgement is based on unpublished data or correspondence with a trialist, we will record this in the relevant section of the 'Characteristics of included studies' table.

Measures of treatment effect

For dichotomous outcomes, we will calculate risk ratios (RRs) with their respective 95% confidence intervals (CIs). For continuous outcomes, we will calculate the mean difference (MD) and 95% CI if studies have reported the outcome on the same scale, and the standardised mean difference (SMD) and 95% CI if different studies have reported the same outcome using different scales. For time‐to‐event data, we will calculate hazard ratios (HRs), which we will combine using the generic inverse‐variance method.

We will report our primary outcome (recurrence) for the following time periods.

  • Within 12 months (short term)

  • Between 12 and 60 months (medium term)

  • After 60 months (long term)

If a study reports recurrence at multiple time points that fall into the same category, we will use the longest eligible time point reported.

For dichotomous outcomes with rare events (i.e. event rate < 10%), serious adverse events, and deaths, we will calculate Mantel‐Haenszel odds ratios (ORs).

If data are available, we will conduct intention‐to‐treat analyses.

Unit of analysis issues

The participant will be the unit of analysis. In the event of intraoperative detection of a contralateral hernia, the participant will only count once in the primary analysis. Similarly, any participant that develops bilateral recurrence will only count once in the primary analysis.

If a single trial compares three or more arms (i.e. two or more treatment arms and one control arm), we will label the arms separately in pair‐wise analyses. To avoid including data for controls more than once in the same comparison, we will either divide the control group into equal parts while assuming equal incidence in these groups, or we will combine multiple treatment arms (e.g. arms that are both 'open surgery'). We will exclude any ineligible treatment arms from the analysis.

For cluster‐RCTs, we will extract the intracluster correlation coefficient (ICC) when available; we will also record the number of clusters per group, the total size of clusters per group, and the unit of randomisation (e.g. hospital or ward). The statistical methods used to analyse the trial results will be documented, along with details describing whether these methods were adjusted for clustering or for other co‐variables. We will pool cluster‐RCT data that have been adjusted for clustering with data from individually randomised trials using the generic inverse variance random‐effects method. When the results of a cluster‐RCT have not been adjusted for clustering, we will adjust the data using the ICC imputed from another study (see section 23.1.4 of the Cochrane Handbook for Systematic Reviews of Interventions; Higgins 2023).

Dealing with missing data

We will contact study authors or data owners to request missing outcome data wherever necessary. We will not impute missing outcome data. Where missing data are substantial (> 5%), we will assign a high risk of bias due to missing outcome data using RoB 2. Where data are missing or participants are lost to follow‐up, the certainty of the evidence will be downgraded due to risk of bias according to the GRADE criteria (Schünemann 2013).

Assessment of heterogeneity

We will assess the presence of clinical heterogeneity within each pair‐wise comparison by comparing the trial and study population characteristics across all eligible trials. For pair‐wise analyses, we will inspect forest plots visually to detect heterogeneity. We will use the I2 statistic to quantify statistical heterogeneity, as follows.

  • 0% to 40%: heterogeneity might not be important.

  • 30% to 60%: may represent moderate heterogeneity.

  • 50% to 90%: may represent substantial heterogeneity.

  • 75% to 100%: represents considerable heterogeneity.

These overlapping intervals reflect that the interpretation of the I2 statistic depends on the value as well as the size and direction of the treatment effect and variance of the I2 estimate (Higgins 2023). For outcomes with considerable heterogeneity (I2 > 75%), we will not present a summary estimate in the forest plot.

Assessment of reporting biases

We will attempt to contact study authors of registered trials and protocols where results have not been published. If we are able to include more than 10 studies in a meta‐analysis, we will create and examine a funnel plot to explore the possibility of publication bias.

Data synthesis

We will undertake meta‐analyses where this is meaningful, that is, if the treatments, the study populations, and the underlying clinical question of included studies are sufficiently homogeneous. We will determine the feasibility of pooling based on the outcomes and intervention/comparison groups reported. When pooling is feasible, we will use a random‐effects meta‐analysis with the DerSimonian and Laird method (DerSimonian 1986). We will include all eligible studies in the primary analysis and not exclude any studies based on their risk of bias. We will report results narratively if data cannot be pooled. We will use Review Manager (RevMan) to carry out statistical analysis (RevMan 2024).

Subgroup analysis and investigation of heterogeneity

We will use subgroup analyses to explore sources of statistical heterogeneity (I2 > 50%) in meta‐analyses that include sufficient studies (five or more). We will perform subgroup analyses according to the following potential effect modifiers.

  • Age (younger than one year, one to nine years, 10 to 17 years)

  • Sex

  • Laparoscopic suturing technique (i.e. intracorporeal versus extracorporeal suturing)

  • Type of repair (i.e. acute or elective repair, given the greater risk of intraoperative and postoperative complications with acute repair)

We will compare subgroups using the formal test for subgroup differences in RevMan (RevMan 2024).

Sensitivity analysis

We will conduct the following sensitivity analyses to determine the robustness of our original analyses.

  • Excluding studies at high risk of bias

  • Excluding cluster‐RCTs

  • Excluding studies of children with bilateral hernia at diagnosis or detected during surgery (given the higher risk of complications with bilateral hernias)

If we make assumptions or borderline decisions during the review process, we will add more sensitivity analyses.

Summary of findings and assessment of the certainty of the evidence

We will use the GRADE approach to interpret findings and create evidence profiles (Schünemann 2013; Schünemann 2022). The profiles will provide the effect estimate and the associated certainty of evidence for each outcome of interest. Three authors (JLM, FL, KP) will assess the certainty of evidence using GRADEpro online Software (GRADEpro GDT). An additional reviewer (RNV) will resolve any disagreements.

Data from RCTs will start at high certainty. Evidence certainty can be downgraded for the following reasons (Guyatt 2011; Puhan 2014).

  • Limitations in study design or execution (overall RoB 2 judgement)

  • Inconsistency of results (heterogeneity)

  • Indirectness of evidence (applicability)

  • Imprecision (few events/wide CIs)

  • Publication bias

The different levels of certainty that result from the GRADE approach will be interpreted as follows.

  • High: we are very confident that the true effect lies close to that of the estimate of the effect.

  • Moderate: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.

  • Low: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect.

  • Very low: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect

We will prepare summary of findings tables for the following three comparisons.

  • Any type of open inguinal hernia repair versus any type of laparoscopic inguinal hernia repair in children of any age

  • Any type of open inguinal hernia repair versus intracorporeal laparoscopic inguinal hernia repair in children of any age

  • Any type of open inguinal hernia repair versus extracorporeal laparoscopic inguinal hernia repair in children of any age

We will include the following outcomes in the summary of findings tables.

  • Recurrence

  • Intraoperative injury of surrounding structures

  • Grade 3a Clavien‐Dindo complications within 30 days after the operation

  • Grade 3b to 4 Clavien‐Dindo complications within 30 days after the operation

  • Grade 5 Clavien‐Dindo complications within 30 days after the operation

  • Postoperative acute pain within 24 hours after the operation

  • Postoperative chronic pain more than six months after the operation

Acknowledgements

Editorial and peer‐reviewer contributions

The following people conducted the editorial process for this article.

  • Sign‐off Editor (final editorial decision): Kristoffer Andresen, Department of surgery, Herlev, Denmark

  • Managing Editor (selected peer reviewers, provided editorial guidance to authors, edited the article): Liz Bickerdike, Cochrane Central Editorial Service

  • Editorial Assistant (conducted editorial policy checks, collated peer‐reviewer comments and supported editorial team): Leticia Rodrigues, Cochrane Central Editorial Service

  • Copy Editor (copy editing and production): Julia Turner, Cochrane Central Production Service

  • Peer‐reviewers (provided comments and recommended an editorial decision): Jo Platt, Central Editorial Information Specialist (search); Nuala Livingstone, Cochrane Evidence Production and Methods Directorate (methods); Hugin Reistrup, Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark (clinical)

Appendices

Appendix 1. Preliminary MEDLINE (Ovid) search strategy

(Ovid MEDLINE(R) ALL 1946 to February 23, 2022):

1. exp Hernia, Inguinal/
2. ((inguinal or groin) and herni*).ti,ab,kf.
3. Herniorrhaphy/
4. (hernioplast* or herniorrhaph* or herniotom* or hernia repair*).ti,ab,kf.
5. (herni* and repair*).ti,ab,kf.
6. or/1‐5
7. exp Laparoscopy/
8. (laparoscop* or minilaparoscop* or keyhole or key hole or SEAL or single incision* or LPEC or SILPEC or transabdominal preperitoneal or TAPP or extraperitoneal or TEP).ti,ab,kf.
9. 7 or 8
10. 6 and 9
11. randomized controlled trial.pt.
12. controlled clinical trial.pt.
13. randomized.ab.
14. placebo.ab.
15. drug therapy.fs.
16. randomly.ab.
17. trial.ab.
18. groups.ab.
19. or/11‐18
20. exp animals/ not humans.sh.
21. 19 not 20
22. 10 and 21
23. limit 22 to "all child (0 to 18 years)"
24. exp Pediatrics/
25. adolescent/ or exp child/ or exp infant/
26. exp Puberty/
27. (child* or school* or infant* or infancy or boy* or girl* or youth* or adolescen* or toddler* or teen* or pubert* or puberal or preschool* or pre‐school* or juvenile* or youngster* or kid or kids or underage* or under age* or pubescen* or prepubescen* or pre‐pube* or prepubert* or schoolage* or pediatric* or paediatric* or preadolescen* or pre‐adolescen* or preteen* or pre‐teen* or kindergar* or minors or PICU or NICU or perinatal* or peri natal* or neonat* or neo‐nat* or postnatal* or post natal* or baby or babies or newborn* or new‐born* or grader* or highschool* or stepchild*).ti,ab,kf.
28. 24 or 25 or 26 or 27
29. 22 and 28
30. 23 or 29
31. limit 30 to yr="1993 ‐Current"
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Contributions of authors

Drafting the protocol: JLM, FL, KP, EC, RNV
Conceiving the protocol: JLM, FL, KP, EC, SHC, RNV
Designing the protocol. JLM, FL, SHC, RNV
Co‐ordinating the protocol: JLM, FL, SHC, RNV
Designing search strategies: EC
Writing the protocol: JLM, FL, KP, EC, SHC, RNV

Sources of support

Internal sources

  • "Personenfoerderung" Program, Switzerland

    "Personenfoerderung" Program of the Department of Surgery at the University Hospital Basel

  • Research Fund for Junior Researchers, Switzerland

    Research Fund for Junior Researchers at the University of Basel

External sources

  • No external sources of support, Other

Declarations of interest

JLM has declared that he has no conflict of interest.
FL has declared that he has no conflict of interest.
KP has declared that she has no conflict of interest.
EC has declared that she has no conflict of interest.
SHC has declared that he has no conflict of interest.
RNV has declared that he has no conflict of interest.

These authors should be considered joint first author

New

References

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