Infantile Hypertrophic Pyloric Stenosis, Pyloromyotomy
Conditions
Brief summary
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.
Interventions
PROCEDUREG-POEM
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.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| episodes of postoperative vomiting | 6 months after surgery | Primary outcomes included episodes of postoperative vomiting in times. |
| major complication | 6 months after surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| other complications | 6 months after surgery | Secondary outcomes included other complications (yes or no) (eg, mucosal injury, delayed mucosal barrier failure, incomplete pyloromyotomy, and respiratory complications without invasive intervention). |
| postoperative pain assessment by Pain assessment for children under four years | 6 months after surgery | 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.) |
| analgesia requirements | 6 months after surgery | Secondary outcomes included analgesia requirements (yes or no). |
| operating and anaesthetic time | 6 months after surgery | Secondary outcomes included operating and anaesthetic time in minutes. |
| postoperative length of stay | 6 months after surgery | Secondary outcomes included postoperative length of stay in days. |
| need for re-operation | 6 months after surgery | Secondary outcomes included need for re-operation (yes or no). |
| time to full enteral feed | 6 months after surgery | Secondary outcomes included time to full enteral feed in hours. |
| myotomy length | 6 months after surgery | Secondary outcomes included myotomy length in centimeters |
Countries
China
Contacts
Primary ContactQuanlin Li
Backup ContactZuqiang Liu
Outcome results
None listed