Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis

Study Overview
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Brief Summary
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Infantile hypertrophic pyloric stenosis (IHPS) is the most common condition for surgical treatment in infant. Traditionally, laparoscopic or open pyloromyotomy are the standard treatments. However, because of severe dehydration, electrolyte disturbance, and malnutrition, these patients have lower tolerance about surgery and recover more slowly than usual. We are going to study the per-oral pyloromyotomy (POP), also named as gastric per-oral endoscopic myotomy (G-POEM), which showed promising results for adult gastroparesis, for a novel application of treating IHPS.

Official Title
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Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis

Conditions
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Infantile Hypertrophic Pyloric Stenosis, Pyloromyotomy

Intervention / Treatment
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* Procedure: G-POEM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of pyloric stenosis with or without sonographic confirmation. Exclusion Criteria: Comorbid conditions that could affect postoperative recovery. Needed an additional procedure during the same anaesthetic.

Ages Eligible for Study
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Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-POEM for infantile hypertrophic pyloric stenosis<br>The procedure includes four steps: a) a transversal mucosal incision was performed at the proximal antrum. b) a submucosal longitudinal tunnel was created across the pyloric ring. c) full-thickness pyloromyotomy was performed, with a little extension of the antrum. After pyloromyotomy, an ultrathin gastroscope was used to inspect the mucosa and pyloric outlet. d) after careful hemostasis, the mucosal entry was closed by clips. | Procedure: G-POEM<br>* Per-oral pyloromyotomy (POP), also named as gastric per-oral endoscopic myotomy (G-POEM), for treating infantile hypertrophic pyloric stenosis (IHPS) has the following steps: mucosal incision, creation of submucosal tunnel, full-thickness pyloromyotomy, closure of the mucosal entry.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| episodes of postoperative vomiting | Primary outcomes included episodes of postoperative vomiting in times. | 6 months after surgery | 
| major complication | Primary outcomes included major complication in times (based on lexicon and Clavien-Dindo classification, eg, vital-sign instability, ICU stay, hospital readmission, conversion to laparoscopic or open pyloromyotomy, invasive postoperative procedure, haemorrhage, blood transfusion, or prolonged hospitalization due to functional impairment). | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operating and anaesthetic time | Secondary outcomes included operating and anaesthetic time in minutes. | 6 months after surgery | 
| myotomy length | Secondary outcomes included myotomy length in centimeters | 6 months after surgery | 
| other complications | Secondary outcomes included other complications (yes or no) (eg, mucosal injury, delayed mucosal barrier failure, incomplete pyloromyotomy, and respiratory complications without invasive intervention). | 6 months after surgery | 
| postoperative pain assessment by Pain assessment for children under four years | Secondary outcomes included postoperative pain assessment in score. This measurement chart is Pain assessment for children under four years which of pain scoring in the postoperative set up is: Cry (yes or no), Posture (relaxed or tense), Expression (relaxed, happy or distressed), Response when spoken to (yes or no). (Gupta A, Kaur K, Sharma S, Goyal S, Arora S, Murthy RS. Clinical aspects of acute post-operative pain management & its assessment. J Adv Pharm Technol Res. 2010;1(2):97-108.) | 6 months after surgery | 
| analgesia requirements | Secondary outcomes included analgesia requirements (yes or no). | 6 months after surgery | 
| time to full enteral feed | Secondary outcomes included time to full enteral feed in hours. | 6 months after surgery | 
| postoperative length of stay | Secondary outcomes included postoperative length of stay in days. | 6 months after surgery | 
| need for re-operation | Secondary outcomes included need for re-operation (yes or no). | 6 months after surgery |