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

Nigel J. Hall, Maurizio Pacilli, Simon Eaton, Kim Reblock, Barbara A. Gaines, Aimee Pastor, Jacob C. Langer, Antti I. Koivusalo, Mikko P. Pakarinen, Lutz Stroedter, Stefan Beyerlein, Munther Haddad, Simon Clarke, Henri Ford, Agostino Pierro

Research output: Contribution to journalArticle

113 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)390-398
Number of pages9
JournalThe Lancet
Volume373
Issue number9661
DOIs
StatePublished - Jan 19 2009
Externally publishedYes

Fingerprint

Pyloric Stenosis
Randomized Controlled Trials
Clinical Trials Data Monitoring Committees
Postoperative Nausea and Vomiting
Ethics Committees
Nursing Staff
Enteral Nutrition
Bicarbonates
Laparoscopy
Gestational Age
Small Intestine
Length of Stay
Therapeutics
Parents
Regression Analysis
Parturition
Pediatrics
Weights and Measures

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Hall, N. J., Pacilli, M., Eaton, S., Reblock, K., Gaines, B. A., Pastor, A., ... Pierro, A. (2009). Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial. The Lancet, 373(9661), 390-398. https://doi.org/10.1016/S0140-6736(09)60006-4

Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis : a double-blind multicentre randomised controlled trial. / Hall, Nigel J.; Pacilli, Maurizio; Eaton, Simon; Reblock, Kim; Gaines, Barbara A.; Pastor, Aimee; Langer, Jacob C.; Koivusalo, Antti I.; Pakarinen, Mikko P.; Stroedter, Lutz; Beyerlein, Stefan; Haddad, Munther; Clarke, Simon; Ford, Henri; Pierro, Agostino.

In: The Lancet, Vol. 373, No. 9661, 19.01.2009, p. 390-398.

Research output: Contribution to journalArticle

Hall, NJ, Pacilli, M, Eaton, S, Reblock, K, Gaines, BA, Pastor, A, Langer, JC, Koivusalo, AI, Pakarinen, MP, Stroedter, L, Beyerlein, S, Haddad, M, Clarke, S, Ford, H & Pierro, A 2009, 'Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial', The Lancet, vol. 373, no. 9661, pp. 390-398. https://doi.org/10.1016/S0140-6736(09)60006-4
Hall, Nigel J. ; Pacilli, Maurizio ; Eaton, Simon ; Reblock, Kim ; Gaines, Barbara A. ; Pastor, Aimee ; Langer, Jacob C. ; Koivusalo, Antti I. ; Pakarinen, Mikko P. ; Stroedter, Lutz ; Beyerlein, Stefan ; Haddad, Munther ; Clarke, Simon ; Ford, Henri ; Pierro, Agostino. / Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis : a double-blind multicentre randomised controlled trial. In: The Lancet. 2009 ; Vol. 373, No. 9661. pp. 390-398.
@article{fcbab67d643941948aa6f0354b796b17,
title = "Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial",
abstract = "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.",
author = "Hall, {Nigel J.} and Maurizio Pacilli and Simon Eaton and Kim Reblock and Gaines, {Barbara A.} and Aimee Pastor and Langer, {Jacob C.} and Koivusalo, {Antti I.} and Pakarinen, {Mikko P.} and Lutz Stroedter and Stefan Beyerlein and Munther Haddad and Simon Clarke and Henri Ford and Agostino Pierro",
year = "2009",
month = "1",
day = "19",
doi = "10.1016/S0140-6736(09)60006-4",
language = "English (US)",
volume = "373",
pages = "390--398",
journal = "The Lancet",
issn = "0140-6736",
publisher = "Elsevier Limited",
number = "9661",

}

TY - JOUR

T1 - Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis

T2 - a double-blind multicentre randomised controlled trial

AU - Hall, Nigel J.

AU - Pacilli, Maurizio

AU - Eaton, Simon

AU - Reblock, Kim

AU - Gaines, Barbara A.

AU - Pastor, Aimee

AU - Langer, Jacob C.

AU - Koivusalo, Antti I.

AU - Pakarinen, Mikko P.

AU - Stroedter, Lutz

AU - Beyerlein, Stefan

AU - Haddad, Munther

AU - Clarke, Simon

AU - Ford, Henri

AU - Pierro, Agostino

PY - 2009/1/19

Y1 - 2009/1/19

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=58749086364&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=58749086364&partnerID=8YFLogxK

U2 - 10.1016/S0140-6736(09)60006-4

DO - 10.1016/S0140-6736(09)60006-4

M3 - Article

C2 - 19155060

AN - SCOPUS:58749086364

VL - 373

SP - 390

EP - 398

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 9661

ER -