FindTrial
Sign In

Comparing current hospital practices with a new fifteen point system to increase patient satisfaction and shorten hospital stay after head and neck cancer operations

Comparison of the efficacy of a 15-element ERAS protocol tailor-made for head and neck free flap oncosurgery with conventional perioperative care: Is ERAS overhyped?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049533
Enrollment
60
Registered
2023-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Fifteen-element Enhanced Recovery after Surgery) ERAS protocol: The ERAS elements are divisible into the preoperative (duration: 24h before surgery till time surgery begins) (patient co
8 hours) (proper nasotracheal tube size, type and fixation, avoidance of tracheostomy and postoperative ventilatory support as far as possible, goal directed fluid therapy, normothermia and increased

Sponsors

Dr Shagun Bhatia Shah
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I-1II 40-85 kg Elective major head neck oncosurgery with free-flap reconstruction (Antero lateral thigh flap/free fibula)

Exclusion criteria

Exclusion criteria: No patient consent Cardiac arrhythmias Left ventricular ejection fraction Uncontrolled diabetes Change in plan from free-flap to pedicel flap/primary closure

Design outcomes

Primary

MeasureTime frame
Length of hospital-stayTimepoint: 2 weeks after surgery—

Secondary

MeasureTime frame
Time to return to intended oncotherapyTimepoint: 1 month after surgery;Serum lactate levelsTimepoint: 5 min before incision 1 min after resection 1 min after surgical reconstruction ;Blood haemoglobin levelsTimepoint: 5 min before incision 1 min after resection 1 min after surgical reconstruction;Length of Surgical Intensive Care Unit stayTimepoint: 1 week after surgery;Postoperative wound/flap related complicationsTimepoint: 1 day after surgery 2 days after surgery 3 days after surgery 4 days after surgery 5 days after surgery;Opioid requirementTimepoint: 1 min after surgery 3 days after surgery;Re-admission/Re-do surgeryTimepoint: 1 week after surgery;Postoperative nausea, vomiting and constipationTimepoint: 1 day after surgery 2 days after surgery;Mean pain visual analog scale scoreTimepoint: 1 day after surgery 2 days after surgery 3 days after surgery;Serum creatinine levelsTimepoint: 1 day before surgery 1 day after surgery—

Countries

India

Contacts

Public ContactDr Shagun Bhatia Shah

Rajiv Gandhi Cancer Institute and Research Centre

drshagun_2010@rediffmail.com09891769779

Outcome results

None listed

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