Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis
Summary
Pyloric stenosis is a condition that develops in infants and that leads to an obstruction of the channel going out of the stomach. This study is being performed to determine if there is an advantage to the laparoscopic approach or the open approach for the surgical correction of the enlarged pylorus.
Description
Pyloromyotomy for pyloric stenosis has traditionally been performed via an open technique. With advancements in minimally invasive surgery in infants a laparoscopic approach has been developed. These two approaches have never been critically evaluated with regard to superiority of one technique over the other. This is a prospective randomized trial involving infants with pyloric stenosis. It will enroll 100 patients in each arm (statistical and power analysis was performed by Steve Simon, PhD). Parental consent will be obtained and the patients will be randomized to undergo open or laparoscopic pyloromyotomy. Patient age at diagnosis, electrolyte disturbances at diagnosis, ultrasound findings, operative approach, length of pyloromyotomy, operative times, time to tolerating full feeds, number of emesis episodes, length of hospitalization, operative charges, and hospital charges will be collected for comparison between the groups.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Hypertrophic Pyloric Stenosis
Intervention
Laparoscopic pyloromyotomy
Location
Children's Mercy Hospital
Kansas CIty
Missouri
United States
64108
Status
Completed
Source
Children's Mercy Hospital Kansas City
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00195949
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Pyloric Stenosis
Narrowing of the pyloric canal with varied etiology. A common form is due to muscle hypertrophy (PYLORIC STENOSIS, HYPERTROPHIC) seen in infants.
Pyloric Stenosis, Hypertrophic
Narrowing of the pyloric canal due to HYPERTROPHY of the surrounding circular muscle. It is usually seen in infants or young children.
Cardiomyopathy, Hypertrophic
A form of CARDIAC MUSCLE disease, characterized by left and/or right ventricular hypertrophy (HYPERTROPHY, LEFT VENTRICULAR; HYPERTROPHY, RIGHT VENTRICULAR), frequent asymmetrical involvement of the HEART SEPTUM, and normal or reduced left ventricular volume. Risk factors include HYPERTENSION; AORTIC STENOSIS; and gene MUTATION; (FAMILIAL HYPERTROPHIC CARDIOMYOPATHY).
Aortic Valve Stenosis
A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
Pyloric Antrum
The region between the sharp indentation at the lower third of the STOMACH (incisura angularis) and the junction of the PYLORUS with the DUODENUM. Pyloric antral glands contain mucus-secreting cells and gastrin-secreting endocrine cells (G CELLS).
Clinical Trials
Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis
Comparison of open and laparoscopic pyloromyotomy
The Effect of Hypertrophic Pyloric Stenosis (HPS) on Sodium Intake in Childhood
The loss of sodium during infancy causes long term changes in sodium intake. Human research shows that the loss of maternal sodium during pregnancy and neonatal after birth causes an incre...
The overall objective of this research study is to determine the effect of a pre-operatively placed nasogastric tube compared to no nasogastric tube, on post-operative emesis rates and pos...
Frequency of Formula Change Prior to the Accurate Diagnosis of Pyloric Stenosis
The purpose of this study is to determine if there is an increase in the frequency of formula change in patients with pyloric sctenosis prior to being correctly diagnosed.
The purpose of this research study is to further establish the diagnostic use of magnetocardiography (MCG) in patients with hypertrophic cardiomyopathy (HCM). The use of MCG has not been...
PubMed Articles
BACKGROUND : Ramstedt pyloromyotomy is still the procedure of choice for infantile hypertrophic pyloric stenosis; however, the best way to approach the pylorus is debated. Recent literature reports ma...
BACKGROUND: There is an ongoing debate about whether laparoscopic pyloromyotomy (LP) or open pyloromyotomy (OP) is the best option for treating hypertrophic pyloric stenosis (HPS). The aim of this stu...
The Cross-technique for single-incision pediatric endosurgical pyloromyotomy.
BACKGROUND: Single-incision pediatric endosurgical (SIPES) pyloromyotomy is frequently used for the treatment of hypertrophic pyloric stenosis at our center. Our initial SIPES approach mirrored the co...
BACKGROUND: Little is known about the direct effect of pneumoperitoneum (PP) on microcirculation and its influence on the quality of tissue perfusion. This study aimed to investigate the intraoperativ...
Seasonal variation of hypertrophic pyloric stenosis: a population-based study.
INTRODUCTION: Seasonal variation in the incidence of hypertrophic pyloric stenosis (HPS) has been long debated. The goal of this study was to determine if seasonal variation exists in the incidence of...
