Review Question
We reviewed the evidence about the effect of open versus laparoscopic pyloromyotomy in infants with a diagnosis of infantile hypertrophic pyloric stenosis. We found 7 studies (reported in 8 reports).
Background
Infantile hypertrophic pyloric stenosis describes a narrowing in the area of the stomach outlet (called the pylorus) in children aged under one year. This condition typically presents at between 3 and 10 weeks of age. It leads to an impaired passage of the stomach contents into the first part of the small intestine (the duodenum). The children may have severe vomiting, which can cause dehydration and can disturb the balance of electrolytes in the body.
The narrowing can be corrected with an operation; the surgeon makes an incision in the thin layer of muscles of the stomach outlet (pyloromyotomy). We included seven studies (with a total of 720 children) in this systematic review that compares the classical open technique for this surgery with a more recent 'laparoscopic' technique. This laparoscopic technique is less invasive because the surgeon avoids a large abdominal cut and uses endoscopic instruments instead.
Search date
The evidence is current to February 2021.
Study characteristics
We searched medical databases up to February 2021 and included seven studies involving 720 participants with infantile pyloric stenosis. All participants were infants ranging in age from 11 to 108 days, and there were more male than female patients. All seven studies reported on mucosal perforation rates, four out of seven RCTs reported on incomplete pyloromyotomy. Time of enrolment ranged from 16 to 56 months.
Study funding sources
Six out of seven included studies did not report funding sources, one trial received charitable funding.
Key results
The review showed that laparoscopic pyloromyotomy may result in a small increase in mucosal perforation rates compared to the open approach. Laparoscopy may also result in higher rates of incomplete pyloromyotomy. The evidence is very uncertain about the effect of the laparoscopic approach on postoperative surgical complications including surgical site infection and incisional hernia. Similarly, very low certainty of evidence does not allow a final conclusion on the effect of open compared to laparoscopic pyloromyotomy on length of stay, time to full feeds and operating time in infantile pyloric stenosis.
Certainty of the evidence
All seven studies had weaknesses that potentially affected the reliability of the results. We considered the certainty of the evidence across all outcomes to be either of low or very low quality.
Laparoscopic pyloromyotomy may result in a small increase in mucosal perforation when compared with open pyloromyotomy for IHPS. There may be an increased risk of incomplete pyloromyotomy following LP compared with OP, but the effect estimate is imprecise and includes the possibility of no difference. We do not know about the effect of LP compared with OP on the need for re-operation, postoperative wound infections or abscess formation, postoperative haematoma or seroma formation, incisional hernia occurrence, length of postoperative stay, time to full feeds, or operating time because the certainty of the evidence was very low for these outcomes. We downgraded the certainty of the evidence for most outcomes due to limitations in the study design (most outcomes were susceptible to detection bias) and imprecision. There is limited evidence available comparing LP with OP for IHPS. The included studies did not provide sufficient information to determine the effect of training, experience, or surgeon preferences on the outcomes assessed.
Infantile hypertrophic pyloric stenosis (IHPS) is a disorder of young children (aged one year or less) and can be treated by laparoscopic (LP) or open (OP) longitudinal myotomy of the pylorus. Since the first description in 1990, LP is being performed more often worldwide.
To compare the efficacy and safety of open versus laparoscopic pyloromyotomy for IHPS.
We conducted a literature search on 04 February 2021 to identify all randomised controlled trials (RCTs), without any language restrictions. We searched the following electronic databases: MEDLINE (1990 to February 2021), Embase (1990 to February 2021), and the Cochrane Central Register of Controlled Trials (CENTRAL). We also searched the Internet using the Google Search engine (www.google.com) and Google Scholar (scholar.google.com) to identify grey literature not indexed in databases.
We included RCTs and quasi-randomised trials comparing LP with OP for hypertrophic pyloric stenosis.
Two review authors independently screened references and extracted data from trial reports. Where outcomes or study details were not reported, we requested missing data from the corresponding authors of the primary RCTs. We used a random-effects model to calculate risk ratios (RRs) for binary outcomes, and mean differences (MDs) for continuous outcomes. Two review authors independently assessed risks of bias. We used GRADE to assess the certainty of the evidence for all outcomes.
The electronic database search resulted in a total of 434 records. After de-duplication, we screened 410 independent publications, and ultimately included seven RCTs (reported in 8 reports) in quantitative analysis. The seven included RCTs enrolled 720 participants (357 with open pyloromyotomy and 363 with laparoscopic pyloromyotomy). One study was a multi-country trial, three were carried out in the USA, and one study each was carried out in France, Japan, and Bangladesh.
The evidence suggests that LP may result in a small increase in mucosal perforation compared with OP (RR 1.60, 95% CI 0.49 to 5.26; 7 studies, 720 participants; low-certainty evidence). LP may result in up to 5 extra instances of mucosal perforation per 1,000 participants; however, the confidence interval ranges from 4 fewer to 44 more per 1,000 participants.
Four RCTs with 502 participants reported on incomplete pyloromyotomy. They indicate that LP may increase the risk of incomplete pyloromyotomy compared with OP, but the confidence interval crosses the line of no effect (RR 7.37, 95% CI 0.92 to 59.11; 4 studies, 502 participants; low-certainty evidence). In the LP groups, 6 cases of incomplete pyloromyotomy were reported in 247 participants while no cases of incomplete pyloromyotomy were reported in the OP groups (from 255 participants).
All included studies (720 participants) reported on postoperative wound infections or abscess formations. The evidence is very uncertain about the effect of LP on postoperative wound infection or abscess formation compared with OP (RR 0.59, 95% CI 0.24 to 1.45; 7 studies, 720 participants; very low-certainty evidence). The evidence is also very uncertain about the effect of LP on postoperative incisional hernia compared with OP (RR 1.01, 95% CI 0.11 to 9.53; 4 studies, 382 participants; very low-certainty evidence).
Length of hospital stay was assessed by five RCTs, including 562 participants. The evidence is very uncertain about the effect of LP compared to OP (mean difference −3.01 hours, 95% CI −8.39 to 2.37 hours; very low-certainty evidence). Time to full feeds was assessed by six studies, including 622 participants. The evidence is very uncertain about the effect of LP on time to full feeds compared with OP (mean difference −5.86 hours, 95% CI −15.95 to 4.24 hours; very low-certainty evidence). The evidence is also very uncertain about the effect of LP on operating time compared with OP (mean difference 0.53 minutes, 95% CI −3.53 to 4.59 minutes; 6 studies, 622 participants; very low-certainty evidence).