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

Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial
Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial
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.
0140-6736
390-398
Hall, Nigel J.
6919e8af-3890-42c1-98a7-c110791957cf
Pacilli, Maurizio
f48aaca5-a083-422b-9784-aacdbe4be5dd
Eaton, Simon
e14103c2-c06a-45e6-87fe-2358a3371283
Reblock, Kim
0b8aa0c9-3ca5-4516-9f51-cf881a0ff678
Gaines, Barbara A.
a9ce5ef5-643c-46c8-baca-134a07db98c6
Pastor, Aimee
88bf1e82-ce67-44ab-b51c-04ce385ff7dc
Langer, Jacob C.
f2b7aeb2-f1a8-4475-b4e8-1a8e31eb1923
Koivusalo, Antti I.
56039c6f-cf11-40dc-89ef-05b4a20b6ef2
Pakarinen, Mikko P.
33c7f3a7-0b7f-44a8-ae37-807659c1105f
Stroedter, Lutz
565210fd-d528-4390-8e99-4caa3eaf6379
Beyerlein, Stefan
e07b9172-96de-4122-8f54-5dfcd4f84f5c
Haddad, Munther
509c6b86-c19f-44e9-a562-bbfe9be7c108
Clarke, Simon
5ab9f970-f2c7-4b51-bf2d-4ee6d45030b9
Ford, Henri
3ef73c96-811a-4fe3-a1f9-c0e7ba5ecbdf
Pierro, Agostino
74bd6b37-4305-47fd-847d-c19a08718997
Hall, Nigel J.
6919e8af-3890-42c1-98a7-c110791957cf
Pacilli, Maurizio
f48aaca5-a083-422b-9784-aacdbe4be5dd
Eaton, Simon
e14103c2-c06a-45e6-87fe-2358a3371283
Reblock, Kim
0b8aa0c9-3ca5-4516-9f51-cf881a0ff678
Gaines, Barbara A.
a9ce5ef5-643c-46c8-baca-134a07db98c6
Pastor, Aimee
88bf1e82-ce67-44ab-b51c-04ce385ff7dc
Langer, Jacob C.
f2b7aeb2-f1a8-4475-b4e8-1a8e31eb1923
Koivusalo, Antti I.
56039c6f-cf11-40dc-89ef-05b4a20b6ef2
Pakarinen, Mikko P.
33c7f3a7-0b7f-44a8-ae37-807659c1105f
Stroedter, Lutz
565210fd-d528-4390-8e99-4caa3eaf6379
Beyerlein, Stefan
e07b9172-96de-4122-8f54-5dfcd4f84f5c
Haddad, Munther
509c6b86-c19f-44e9-a562-bbfe9be7c108
Clarke, Simon
5ab9f970-f2c7-4b51-bf2d-4ee6d45030b9
Ford, Henri
3ef73c96-811a-4fe3-a1f9-c0e7ba5ecbdf
Pierro, Agostino
74bd6b37-4305-47fd-847d-c19a08718997

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 and Pierro, Agostino (2009) Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial. The Lancet, 373 (9661), 390-398. (doi:10.1016/S0140-6736(09)60006-4). (PMID:19155060)

Record type: Article

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.

This record has no associated files available for download.

More information

Published date: 31 January 2009
Organisations: Human Development & Health

Identifiers

Local EPrints ID: 378469
URI: http://eprints.soton.ac.uk/id/eprint/378469
ISSN: 0140-6736
PURE UUID: a2eacd34-f7ee-4f12-99f0-800187109dd1
ORCID for Nigel J. Hall: ORCID iD orcid.org/0000-0001-8570-9374

Catalogue record

Date deposited: 07 Jul 2015 16:21
Last modified: 15 Mar 2024 03:38

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Contributors

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

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