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Improving Recovery After Ovarian Cancer Surgery: ERAS Alone vs. ERAS with Prehabilitation.

Evaluation of perioperative outcomes with enhanced recovery after surgery alone versus combined enhanced recovery after surgery and prehabilitation in patients undergoing surgery for advanced ovarian cancer:- An open labelled randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080764
Enrollment
50
Registered
2025-02-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: C569- Malignant neoplasm of unspecifiedovary

Interventions

Intervention1: ERAS plus Prehabilitation: All eligible patients planned for primary upfront or interval debulking surgery after chemotherapy for advanced ovarian cancer will be recruited to the study.

Sponsors

Pooja
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Advanced ovarian cancer for upfront surgery or after NACT 2. Preoperative schedule that allows from at least 3 weeks for upfront surgery and upto three months for interval debulking surgery 3. Treatment naive patients 4. Eastern Cooperative Oncology Group Performance Status of up to 2.

Exclusion criteria

Exclusion criteria: 1. Significant comorbidities or limitation of locomotion that prohibit the patient to perform prehabilitation activities 2. Emergency surgeries 3. Surgeries by minimally invasive approach (laparoscopy or robotics) 4. Patients suffering from depression and major psychiatric illness

Design outcomes

Primary

MeasureTime frame
1. Functional capacity assessment using cardiopulmonary testing by six minute walk test (6 MWT) and pulmonary function tests using spirometry. 2. Nutritional assessment by serum albumin levels, body mass index, and hand grip strength test 3. Quality of life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ- C30) 4. To measure intraoperative anaesthetic parameters - peak pressure, plateau pressure, lactate levels, tidal volume, temperature, urine output, ionotropic requirement, cardiac ejection fraction, problems during weaning off (extubation failure and immediate need for re-intubation and post extubation stridor) 5. To measure intraoperative surgical outcomes - duration of surgery in minutes , blood loss, transfusion of blood and blood products, cytoreductive outcomes, surgical complexity score.Timepoint: 3 weeks to 3 months

Secondary

MeasureTime frame
1. Proportion of patients with adherence to prehabilitation program as measured by asking them to maintain and enter daily records of exercises, diet and pshycological activities in a provided chart if patients are at home or recording in the proforma if hospitalised. 2. Adverse events of prehabilitation - injuries during exercise, gastrointestinal symptoms (nausea, vomiting, diarrhoea), withdrawal symptoms due to cessation of smoking (will take consultation from psychiatry team for opinion and management if needed)Timepoint: 3 weeks to 3 months

Countries

India

Contacts

Public ContactProf Shalini Rajaram

All India Institute of Medical Sciences, Rishikesh

rajaram.shalini@gmail.com9810704434

Outcome results

None listed

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