Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial

doi:10.1016/S0140-6736(09)60006-4

The Lancet

Volume 373, Issue 9661, 31 January–6 February 2009, Pages 390-398

https://doi.org/10.1016/S0140-6736(09)60006-4 Get rights and content

Summary

Background

A laparoscopic approach to pyloromyotomy for infantile pyloric stenosis has gained popularity but its effectiveness remains unproven. We aimed to compare outcomes after open or laparoscopic pyloromyotomy for the treatment of pyloric stenosis.

Methods

We did a multicentre international, double-blind, randomised, controlled trial between June, 2004, and May, 2007, across six tertiary paediatric surgical centres. 180 infants were randomly assigned to open (n=93) or laparoscopic pyloromyotomy (n=87) with minimisation for age, weight, gestational age at birth, bicarbonate at initial presentation, feeding type, preoperative duration of symptoms, and trial centre. Infants with a diagnosis of pyloric stenosis were eligible. Primary outcomes were time to achieve full enteral feed and duration of postoperative recovery. We aimed to recruit 200 infants (100 per group); however, the data monitoring and ethics committee recommended halting the trial before full recruitment because of significant treatment benefit in one group at interim analysis. Participants, parents, and nursing staff were unaware of treatment. Data were analysed on an intention-to-treat basis with regression analysis. The trial is registered with ClinicalTrials.gov, number NCT00144924.

Findings

Time to achieve full enteral feeding in the open pyloromyotomy group was (median [IQR]) 23·9 h (16·0–41·0) versus 18·5 h (12·3–24·0; p=0·002) in the laparoscopic group; postoperative length of stay was 43·8 h (25·3–55·6) versus 33·6 h (22·9–48·1; p=0·027). Postoperative vomiting, and intra-operative and postoperative complications were similar between the two groups.

Interpretation

Both open and laparoscopic pyloromyotomy are safe procedures for the management of pyloric stenosis. However, laparoscopy has advantages over open pyloromyotomy, and we recommend its use in centres with suitable laparoscopic experience.

Funding

Sir Arthur Halley Stewart Trust.

Introduction

Infantile hypertrophic pyloric stenosis is one of the most common neonatal conditions needing surgery. Ramstedt's pyloromyotomy for pyloric stenosis, first described in 1912,¹ is still a safe, effective procedure with a low risk of complications. After the introduction of small (3–5 mm) laparoscopic equipment to enable access into the abdomen of infants, laparoscopic pyloromyotomy was described in 1991,² and several centres have used this technique. Initial reports of better cosmesis and faster postoperative recovery after this procedure3, 4, 5, 6, 7 were not subsequently confirmed.8, 9, 10 Some authors have questioned the safety of laparoscopy because of increased frequency of surgical complications compared with open pyloromyotomy.11, 12

We did a systematic review and meta-analysis of published data up to 2004,¹³ which suggested that postoperative recovery was shorter after laparoscopy than after open pyloromyotomy, but raised concerns of a higher complication rate. At that time, no large randomised controlled trials had been done to compare these two procedures, but only retrospective studies, mainly from single institutions. Recently, two large studies have been reported at single centres in North America¹⁴ and France.¹⁵ One¹⁴ indicated that laparoscopy was better than open pyloromyotomy because of fewer episodes of postoperative vomiting and decreased need for postoperative analgesia, whereas the other¹⁵ concluded the opposite because of a slightly increased risk of incomplete pyloromyotomy after laparoscopy. Table 1 shows main outcomes from all comparative studies of laparoscopy and open pyloromyotomy.

We therefore did an international, multicentre, double-blind, randomised controlled trial to compare laparoscopic and open pyloromyotomy for the treatment of pyloric stenosis.

Section snippets

Trial design and participants

This study was done at six centres (table 2) from June, 2004, to May, 2007, and coordinated from the Institute of Child Health (London, UK). Ethical approval was obtained from the local research ethics committee in every institution before recruitment. Infants were randomly assigned to laparoscopic or open pyloromyotomy, and standardised protocols were used for anaesthesia, postoperative analgesia, and feed. The study was done in accordance with published guidelines²⁴ and is reported in

Results

Figure 2 shows the trial profile and table 3 the demographic and clinical characteristics of patients at enrolment.

Analysis of the primary outcomes showed that, after laparoscopic pyloromyotomy, infants achieved full enteral feed more quickly and were discharged earlier than those undergoing open pyloromyotomy (table 4 and figure 3). To determine whether this difference was apparent soon after surgery, the time at which the first full enteral feed was tolerated without substantial vomiting was

Discussion

With standardised treatments to reduce potential bias between groups, time to achieve full enteral feed and to discharge after laparoscopic pyloromyotomy were significantly reduced compared with those after open pyloromyotomy. We chose these as primary outcomes because any difference in these measures between treatment groups would be of clinical importance and could determine operative approach. Our decision to analyse both was due to factors additional to feeding tolerance, such as wound

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To examine factors that affect the severity of pyloric hypertrophy, post-operative feeding and nutritional recovery in infantile hypertrophic pyloric stenosis (IHPS).
Medical records of infants diagnosed with IHPS at a single tertiary center between 2009 and 2018 were retrospectively reviewed. Clinical characteristics, biochemistry data and outcome were assessed for their association with the severity of pyloric hypertrophy and post-operative recovery. Nutritional recovery was assessed using weight-for-age status improvement after surgery.
Eighty-five patients were recruited in this study. The mean pre-operative weight-for-age percentile was 18.2. Elevated bicarbonate was positively correlated with symptom duration (p = 0.007). Pyloric muscle thickness was significantly correlated with age, weight, and symptom duration (p = 0.004, 0.003, 0.008, respectively). The mean weight-for-age percentile increased to 41.6 by post-operative weeks 6–8. Pyloric muscle thickness was negatively correlated with nutritional recovery by post-operative weeks 6–8 (p = 0.003). In multivariable analysis, pyloric length related to nutritional recovery at week 1–2 postoperatively (OR = 1.42, p = 0.030, 95% CI = 0.03–1.94), and pyloric muscle thickness related to nutritional recovery at week 6–8 postoperatively (OR = 4.08, p = 0.032, 95% CI = 1.13–14.7).
Our study indicated that favorable nutritional outcome and successful weight gain was observed 6–8 weeks after surgery in children with IHPS. Pyloric muscle thickness positively correlated with age, weight, symptom duration, and favorable nutritional recovery. Serum bicarbonate showed a positive correlation with symptom duration.
Open Versus Laparoscopic Pyloromyotomy for Pyloric Stenosis—A Systematic Review and Meta-Analysis
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Citation Excerpt :
For this reason, both studies were classified as high risk for selection bias. The remaining five studies described appropriate methods for randomly allocating participants (low risk for selection bias).19,26-28,30 Among the included studies, two of seven applied appropriate blinding strategies for avoiding performance bias.19,27
Infantile hypertrophic pyloric stenosis is treated by either open pyloromyotomy (OP) or laparoscopic pyloromyotomy (LP). The aim of this meta-analysis was to compare the open versus laparoscopic technique.
A literature search was conducted from 1990 to February 2021 using the electronic databases MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. Primary outcomes were mucosal perforation and incomplete pyloromyotomy. Secondary outcomes consisted of length of hospital stay, time to full feeds, operating time, postoperative wound infection/abscess, incisional hernia, hematoma/seroma formation, and death.
Seven randomized controlled trials including 720 patients (357 with OP and 363 with LP) were included. Mucosal perforation rate was not different between groups (relative risk [RR] LP versus OP 1.60 [0.49-5.26]). LP was associated with nonsignificant higher risk of incomplete pyloromyotomy (RR 7.37 [0.92-59.11]). There was no difference in neither postoperative wound infections after LP compared with OP (RR 0.59 [0.24-1.45]) nor in postoperative seroma/hematoma formation (RR 3.44 [0.39-30.43]) or occurrence of incisional hernias (RR 1.01 [0.11-9.53]). Length of hospital stay (−3.01 h for LP [−8.39 to 2.37 h]) and time to full feeds (−5.86 h for LP [−15.95 to 4.24 h]) were nonsignificantly shorter after LP. Operation time was almost identical between groups (+0.53 min for LP [−3.53 to 4.59 min]).
On a meta-level, there is no precise effect estimate indicating that LP carries a higher risk for mucosal perforation or incomplete pyloromyotomies compared with the open equivalent. Because of very low certainty of evidence, we do not know about the effect of the laparoscopic approach on postoperative wound infections, postoperative hematoma or seroma formation, incisional hernia occurrence, length of postoperative stay, time to full feeds, or operating time.
Laparoscopic versus open pyloromyotomies: Outcomes and disparities in pyloric stenosis
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Citation Excerpt :
Laparoscopy in pyloromyotomy has been slower to be accepted widely due to early studies that showed higher rates of mucosal perforation [11]. However, more recently several studies have reported that laparoscopy [11–14] has lower rates of complications. Complications are rare in laparoscopic and open pyloromyotomy.
Pyloromyotomy for hypertrophic pyloric stenosis (HPS) is one of the most common non-elective operations performed in the neonatal period. This project aims to explore outcomes of pyloromyotomy and compare differences between laparoscopic versus open pyloromyotomies in newborns diagnosed with HPS.
The Nationwide Readmissions Database (NRD) from 2010 to 2014 was queried to identify patients diagnosed with HPS that underwent repair.
In total, 30,915 children (18% female) underwent pyloromyotomy for HPS. Median length of stay for index admission was 2 days. A total of 212 (0.7%) patients required a redo pyloromyotomy. 127 (60%) were performed during index admission. Readmission rate at 30 days was 3% and 5% at one year, and 22% presented to a different hospital. The most common indications for readmission were feeding intolerance (24%), dehydration (10%), and malnutrition (10%). Patients from low-income households were more likely to present with malnutrition and weight loss (9% vs 4%, p<0.001) and had higher readmission rates (8% vs 4%, p<0.001). Laparoscopic pyloromyotomies accounted for 10% (n = 2951) of cases. Those undergoing laparoscopy were less likely to have electrolyte disturbances (41% vs 54%, p<0.001) or weight loss (2% vs 11%, p<0.001) on admission. The rate of open conversion was 1%. Intraoperative perforation was not more common in laparoscopic than open cases. Open pyloromyotomies had higher 30-day readmission rates and more surgical site infections.
Complications from pyloromyotomies are rare. Although infrequent, the incidence of incomplete pyloromyotomy is higher than previously reported and more common with open approaches. Newborns from low-income households are more likely to present with advanced symptoms and have disproportionately higher rates of readmission.
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Recurrent hypertrophic pyloric stenosis in an 8-week-old
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Hypertrophic pyloric stenosis is a common cause of gastric outlet obstruction in the new born population. Pyloromyotomy is the treatment of choice following resuscitation, with relatively few complications. Recurrent pyloric stenosis is a rare complication with only eight cases reported in the literature. Although difficult to distinguish between an incomplete pyloromyotomy, there have been multiple cases presented in the literature of recurrent pyloric stenosis. Here we report a case of true recurrent hypertrophic pyloric stenosis treated successfully with a repeat laparoscopic pyloromyotomy.
Postoperative Opioid Analgesia Impacts Resource Utilization in Infants Undergoing Pyloromyotomy
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Opioid analgesia is often avoided in infants undergoing pyloromyotomy. Previous studies highlight an association between opioid use and prolonged hospitalization after pyloromyotomy. However, the impact of opioid use on healthcare resource utilization and cost is unknown. We hypothesized that use of opioids after pyloromyotomy is associated with increased resource utilization and costs.
A retrospective cohort study was conducted identifying healthy infants aged <6 mo with a diagnosis of pyloric stenosis who underwent pyloromyotomy from 2005 to 2015 among 47 children's hospitals using the Pediatric Health Information System database. Time of opioid exposure was categorized as day of surgery (DOS) alone, postoperative use alone, or combined DOS and postoperative use. Primary outcomes were the standardized unit cost, a proxy for resource utilization, billed charges to the patient/insurer, and hospital costs. A multivariable log-linear mixed-effects model was used to adjust for patient and hospital level factors.
Overall, 11,008 infants underwent pyloromyotomy with 2842 (26%) receiving perioperative opioids. Most opioid use was confined to the DOS alone (n = 2,158, 19.6%). Infants who received opioids on DOS and postoperatively exhibited 13% (95% confidence interval [CI]: 7%-20%, P-value <0.001) higher total resource utilization compared with infants who did not receive any opioids. Billed charges were 3% higher (95% CI: 0%-5%, P-value = 0.034) for infants receiving opioids isolated to the postoperative period alone and 6% higher (95% CI: 2%-11%, P-value = 0.004) for infants receiving opioids on the DOS and postoperatively.
Postoperative opioid use among infants who underwent pyloromyotomy was associated with increased resource utilization and costs.
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ArticlesRecovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial

Summary

Background

Methods

Findings

Interpretation

Funding

Introduction

Section snippets

Trial design and participants

Results

Discussion

J Pediatr Surg

Semin Pediatr Surg

J Pediatr Surg

J Pediatr Surg

J Pediatr Surg

J Pediatr Surg

J Pediatr Surg

J Pediatr Surg

J Pediatr Surg

J Am Coll Surg

J Pediatr Surg

J Pediatr Surg

J Pediatr Surg

Zur operation der angeborenen pylorus stenose

Med Klin

Pyloromyotomy: comparison between laparoscopic and open surgical techniques

J Laparoendosc Surg

Is laparoscopic pyloromyotomy superior to open surgery?

Surg Endosc

Laparoscopic pyloromyotomy: redefining the advantages of a novel technique

J Soc Laparoend Surg

Articles
Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial