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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Zhongshan hospital
Shanghai, China
RECRUITINGepisodes of postoperative vomiting
Primary outcomes included episodes of postoperative vomiting in times.
Time frame: 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).
Time frame: 6 months after surgery
operating and anaesthetic time
Secondary outcomes included operating and anaesthetic time in minutes.
Time frame: 6 months after surgery
myotomy length
Secondary outcomes included myotomy length in centimeters
Time frame: 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).
Time frame: 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.)
Time frame: 6 months after surgery
analgesia requirements
Secondary outcomes included analgesia requirements (yes or no).
Time frame: 6 months after surgery
time to full enteral feed
Secondary outcomes included time to full enteral feed in hours.
Time frame: 6 months after surgery
postoperative length of stay
Secondary outcomes included postoperative length of stay in days.
Time frame: 6 months after surgery
need for re-operation
Secondary outcomes included need for re-operation (yes or no).
Time frame: 6 months after surgery
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