A study to look at outcomes after introducing pre, intra and post operative protocols for enhanced recovery in children undergoing choledochal cyst excisio
Phase 3
- Conditions
- Health Condition 1: K838- Other specified diseases of biliary tractHealth Condition 2: K838- Other specified diseases of biliary tract
- Registration Number
- CTRI/2023/09/057547
- Lead Sponsor
- Christian Medical College Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. All children less than 15 years of age with a diagnosis of choledochal cyst undergoing an elective excision and hepatico-enterostomy
2. Both open and minimal access approaches
Exclusion Criteria
1. Children requiring emergency intervention like perforated choledochal cyst
2. Parents who do not consent for the child to be part of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of hospital stayTimepoint: From day of admission to the day child is fit for discharge (discharge criteria as noted above)
- Secondary Outcome Measures
Name Time Method 1. Duration of operation – from time of induction of anaesthesia to extubation <br/ ><br>2. Pain control via visual analogue scale and opioid requirement – in morphine equivalents per Kg <br/ ><br>3. Complications as per Clavien-Dindo classification – number and severity <br/ ><br>4. Cost of in hospital admission <br/ ><br>5. Quality of recovery 9 score – Myles et al (Attached table below) <br/ ><br>6. Thirty-day readmission rate <br/ ><br>7. Time to NG removal and first feeds <br/ ><br>8. Time to establish full oral feeds <br/ ><br>9. Time to mobilization <br/ ><br>10. Time to normal bowel movements – stools and flatus.Timepoint: From time of admission till fit for discharge