Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis
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|ClinicalTrials.gov Identifier: NCT04148040|
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : November 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infantile Hypertrophic Pyloric Stenosis Pyloromyotomy||Procedure: G-POEM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: G-POEM for infantile hypertrophic pyloric stenosis
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.
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.
- episodes of postoperative vomiting [ Time Frame: 6 months after surgery ]Primary outcomes included episodes of postoperative vomiting in times.
- major complication [ Time Frame: 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).
- operating and anaesthetic time [ Time Frame: 6 months after surgery ]Secondary outcomes included operating and anaesthetic time in minutes.
- myotomy length [ Time Frame: 6 months after surgery ]Secondary outcomes included myotomy length in centimeters
- other complications [ Time Frame: 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" [ Time Frame: 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 [ Time Frame: 6 months after surgery ]Secondary outcomes included analgesia requirements (yes or no).
- time to full enteral feed [ Time Frame: 6 months after surgery ]Secondary outcomes included time to full enteral feed in hours.
- postoperative length of stay [ Time Frame: 6 months after surgery ]Secondary outcomes included postoperative length of stay in days.
- need for re-operation [ Time Frame: 6 months after surgery ]Secondary outcomes included need for re-operation (yes or no).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04148040
|Contact: Quanlin Lifirstname.lastname@example.org|
|Contact: Zuqiang Liuemail@example.com|
|Study Chair:||Pinghong Zhou||Shanghai Zhongshan Hospital|