小児鼠径ヘルニアに対する腹腔鏡下手術と開腹手術の比較

Inguinal hernia is one of the most prevalent paediatric conditions requiring surgical treatment. It can be repaired either by the laparoscopic technique or open surgery. There is a need for a high-quality systematic review with meta-analyses to evaluate the laparoscopic approach versus the open approach for inguinal hernia repair in children, as available evidence is based on different interpretations or calculations of the same RCTs.

To compare the benefits and harms of laparoscopic versus open repair in paediatric inguinal hernia.

We searched CENTRAL, MEDLINE, and Embase in May and June 2025. As the first laparoscopic repair of paediatric inguinal hernia was conducted in 1993, the search focused on studies published from that year onwards. We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform, ClinicalTrials.gov, and the ISRCTN registry. We screened reference lists of included studies and related systematic reviews for additional references. We also searched PubMed for retractions and errata (none identified).

We included studies that reported on children (aged under 18 years) of any sex and race with a diagnosis of unilateral or bilateral inguinal hernia. Accepted methods of diagnosis were clinical examination, photo documentation by parents/guardians, ultrasound, or intraoperative detection (of contralateral hernia). Only randomised controlled trials (RCTs) comparing mesh-free laparoscopic versus open repair were considered for this review, irrespective of their publication status or language. Quasi-randomised controlled trials were deemed ineligible.

Our critical outcome was recurrence (< 12 months, 12 to 60 months, and > 60 months follow-up), assessed by clinical examination with or without verification by diagnostic imaging. Both repaired and unrepaired recurrences were considered. Important outcomes comprised intraoperative complications (intraoperative injury and conversion), complications according to Clavien-Dindo 3a, 3b to 4, and 5 within 30 days after the operation, postoperative acute pain within 24 hours, and chronic pain persisting for more than six months after surgery 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.

Three review authors (JLM, FL, KP) independently assessed the risk of bias for each included study using the updated Cochrane risk of bias tool (RoB 2).

We used random-effects meta-analyses to estimate treatment effects for dichotomous outcomes as odds ratios (ORs) and for continuous outcomes as mean differences (MDs), both with 95% confidence intervals (CIs). We explored heterogeneity using the I² statistic and conducted subgroup analyses based on laparoscopic suturing technique (extracorporeal versus intracorporeal). We used the GRADE approach to interpret findings and to assess the certainty of evidence.

We included 12 randomised controlled trials analysing 1247 children undergoing either laparoscopic or open inguinal hernia repair. Studies were conducted across various countries and healthcare settings. The age of participants included ranged from approximately 3 months to 15 years, with the majority being preschool-aged children. Follow-up durations ranged from two months to two years. Most studies reported recurrence, complications, and acute postoperative pain. Chronic pain and long-term complications were not reported. All studies utilised a parallel-group design. Ten of the included studies were conducted at single centres.

Pooled analysis showed no clear difference in recurrence between laparoscopic and open repair (OR 0.64, 95% CI 0.26 to 1.61; P = 0.35; 9 studies, 1099 participants; low-certainty evidence). No studies reported on long-term recurrence. The certainty of the evidence is low due to imprecision (downgraded by two levels due to the wide CI and low number of participants). There were no intraoperative injuries reported across studies, preventing estimation of effect size (5 studies, 450 participants; low-certainty evidence). We downgraded the certainty of the evidence by two levels due to imprecision. We could not pool data for Clavien-Dindo grade 3a and grade 5 as there were no events in either group (7 studies, 573 participants; low-certainty evidence). We downgraded the certainty of the evidence by two levels due to imprecision. For Clavien-Dindo grades 3b to 4, there was no difference between laparoscopic and open repair (OR 1.82, 95% CI 0.07 to 47.61; P = 0.72; 7 studies, 573 participants; low-certainty evidence). We downgraded the certainty of the evidence by two levels due to imprecision. For postoperative acute pain, no differences were detected at 24 hours (4 studies, 220 participants). The certainty of the evidence was very low due to downgrading one level for risk of bias, one level due to high heterogeneity, and one level due to indirectness (three studies only included boys) and imprecision (low number of participants). Postoperative chronic pain was not reported by any study. For recurrence, there was no evidence of a subgroup difference between extracorporeal suturing techniques (7 studies, 927 participants) and intracorporeal suturing technique (2 studies, 172 patients) (test for subgroup differences: Chi² = 0.83, df = 1 (P = 0.36), I² = 0%).

Laparoscopic and open inguinal hernia repair in children appears to result in comparable recurrence rates. There are inadequate data to draw conclusions about the effects of laparoscopic compared to open surgery on intraoperative injuries, Clavien-Dindo grade 3a and 5, or acute postoperative pain. There may be little to no difference between laparoscopic and open surgery concerning Clavien-Dindo grades 3b to 4. Furthermore, no studies evaluated chronic pain and the heterogeneity in surgical techniques suggests caution is needed in the generalisation of findings. The available data are of very low to low certainty, so we are not able to draw conclusions about the effects of laparoscopic versus open paediatric inguinal hernia repair. Future high-quality trials with standardised outcome reporting are needed.

We have not received funding for this systematic review.

Protocol (2024) DOI: 10.1002/14651858.CD015470.