Adherence patterns to ERAS and its association with treatment outcomes in Oral Cavity Squamous Cell Carcinoma.

Phase 2/3

Completed

Conditions: Malignant neoplasms of lip, oral cavity and pharynx, (2) ICD-10 Condition: C000||Malignant neoplasm of external upper lip,

Registration Number: CTRI/2022/09/045750

Lead Sponsor: JIPMER

Brief Summary: Enhanced recovery after surgery (ERAS) is a multidisciplinary approach consisting of perioperative and operative management aiming at improving clinical outcomes.

This is achieved through principles such as patient education, goal-directed fluid therapy, multimodal analgesia, and early mobilization with help of a team consisting of nurses, anesthesiologists, dieticians, physical specialists, social workers and surgeons.

Oral cancer with a 5-year prevalence of more than 3 lakh is one of the most common cancers in the Indian subcontinent. Surgery is an integral part of treatment and that enormous prevalence along with morbidity of surgery amounts to a huge burden on our Health care system. Advantages of Enhanced recovery after surgery (ERAS) has been proven in multiple fields such as colorectal surgery, hepatobiliary surgery, and thoracic surgery with factors such as reduced complication rates and shorter hospital length of stay (LOS).

Novelty:

Though there are studies evaluating the effect of Enhanced Recovery After Surgery in Oral Oncosurgery, they are limited in terms of the cases studied, having retrospective analysis and inclusion of only a particular subgroup of patients.

Expected Outcomes:

In this study, we expect to find adherence and response of ERAS in patients with Oral cavity carcinoma undergoing surgery by the specified perioperative and operative intervention as an adjunct to the standard of care that may reduce the hospital stay and reduce the complications.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 108

Inclusion Criteria

1 Adult Population age between 18 years to 70 years 2.
Diagnosed case of Oral cavity squamous cell carcinoma undergoing surgery 3.
ECOG Performance Status of 0 to 2.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Adherence patterns to Enhanced Recovery After Surgery protocol.	30 days
2. Association of the adherence patterns to Enhanced Recovery After Surgery protocol with the postsurgical outcomes among the patients with Oral Cavity Squamous Cell Carcinoma undergoing surgery.	30 days

Secondary Outcome Measures

Name	Time	Method
length of hospital stay, mean ICU stay, 30-day readmission rate, morbidity and mortality with historical controls (pre ERAS era).	30 days

Trial Locations

Locations (1): JIPMER
🇮🇳
Pondicherry, PONDICHERRY, India
JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
Aman Prakash
Principal investigator
7278625446
amansog2022@gmail.com