Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis
- Conditions
- PyloromyotomyInfantile Hypertrophic Pyloric Stenosis
- Interventions
- Procedure: G-POEM
- Registration Number
- NCT04148040
- Lead Sponsor
- Shanghai Zhongshan Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Clinical diagnosis of pyloric stenosis with or without sonographic confirmation.
- Comorbid conditions that could affect postoperative recovery.
- Needed an additional procedure during the same anaesthetic.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description G-POEM for infantile hypertrophic pyloric stenosis G-POEM 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method need for re-operation 6 months after surgery Secondary outcomes included need for re-operation (yes or no).
operating and anaesthetic time 6 months after surgery Secondary outcomes included operating and anaesthetic time in minutes.
analgesia requirements 6 months after surgery Secondary outcomes included analgesia requirements (yes or no).
myotomy length 6 months after surgery Secondary outcomes included myotomy length in centimeters
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 length of stay 6 months after surgery Secondary outcomes included postoperative length of stay in days.
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.)time to full enteral feed 6 months after surgery Secondary outcomes included time to full enteral feed in hours.
Trial Locations
- Locations (1)
Zhongshan hospital
🇨🇳Shanghai, China