Infantile Hypertrophic Pyloric Stenosis Clinical Trial
Official title:
Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis
| NCT number | NCT04148040 |
| Other study ID # | ZSLQL |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 1, 2019 |
| Est. completion date | December 2020 |
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | December 2020 |
| Est. primary completion date | December 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 3 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Zhongshan hospital | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Zhongshan Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | episodes of postoperative vomiting | Primary outcomes included episodes of postoperative vomiting in times. | 6 months after surgery | |
| Primary | 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 | operating and anaesthetic time | Secondary outcomes included operating and anaesthetic time in minutes. | 6 months after surgery | |
| Secondary | myotomy length | Secondary outcomes included myotomy length in centimeters | 6 months after surgery | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | analgesia requirements | Secondary outcomes included analgesia requirements (yes or no). | 6 months after surgery | |
| Secondary | time to full enteral feed | Secondary outcomes included time to full enteral feed in hours. | 6 months after surgery | |
| Secondary | postoperative length of stay | Secondary outcomes included postoperative length of stay in days. | 6 months after surgery | |
| Secondary | need for re-operation | Secondary outcomes included need for re-operation (yes or no). | 6 months after surgery |