A study to look at outcomes after introducing pre, intra and post operative protocols for enhanced recovery in children undergoing choledochal cyst excision

Implementing Enhanced Recovery After Surgery Protocols in paediatric patients undergoing choledochal cyst excision – A Randomized Control Trial - CERAS study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057547

Enrollment

Registered

2023-09-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K838- Other specified diseases of biliary tract Health Condition 2: K838- Other specified diseases of biliary tract

Interventions

Intervention1: Enhanced Recovery protocol after Surgery for choledochal cyst: A set of protocols will be implemented in the case arm. These will be aimed at enhancing recovery after surgery and will i

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Duration of hospital stayTimepoint: From day of admission to the day child is fit for discharge (discharge criteria as noted above)	—

Secondary

Measure	Time frame
1. Duration of operation – from time of induction of anaesthesia to extubation 2. Pain control via visual analogue scale and opioid requirement – in morphine equivalents per Kg 3. Complications as per Clavien-Dindo classification – number and severity 4. Cost of in hospital admission 5. Quality of recovery 9 score – Myles et al (Attached table below) 6. Thirty-day readmission rate 7. Time to NG removal and first feeds 8. Time to establish full oral feeds 9. Time to mobilization 10. Time to normal bowel movements – stools and flatus.Timepoint: From time of admission till fit for discharge	—

Measure

Time frame

1. Duration of operation – from time of induction of anaesthesia to extubation 2. Pain control via visual analogue scale and opioid requirement – in morphine equivalents per Kg 3. Complications as per Clavien-Dindo classification – number and severity 4. Cost of in hospital admission 5. Quality of recovery 9 score – Myles et al (Attached table below) 6. Thirty-day readmission rate 7. Time to NG removal and first feeds 8. Time to establish full oral feeds 9. Time to mobilization 10. Time to normal bowel movements – stools and flatus.Timepoint: From time of admission till fit for discharge

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Countries

India

Contacts

Public ContactNiveditha Shama Viswanathan

Christian Medical College, Vellore

nivi.here@gmail.com09787930493

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026