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临床试验/CTRI/2026/01/100326
CTRI/2026/01/100326尚未招募不适用

Prehabilitation and Early Recovery After Surgery (ERAS) in head and neck cancer patients undergoing surgery (PreERA)

Institution1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2026年1月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
116
试验地点
1

研究概览

简要总结

This stratified randomized controlled trial evaluates the impact of a structured multidisciplinary prehabilitation program integrated with Enhanced Recovery After Surgery protocols on outcomes in patients undergoing elective head and neck cancer surgery with flap reconstruction. Adults aged from 18 years to 90 years with buccal mucosa carcinoma scheduled for bite composite resection will be randomized  to either standard perioperative care or a comprehensive prehabilitation program delivered for 2 weeks preoperatively. The intervention includes medical optimization, nutritional assessment and supplementation, anemia correction, structured physiotherapy, respiratory training, speech and swallowing therapy, and psychological counselling for stress and addiction management. ERAS components will be implemented perioperatively in both groups. The primary outcome is postoperative length of hospital stay. Secondary outcomes include postoperative morbidity , pulmonary complications, ICU stay, readmissions, mortality, functional recovery, nutritional status, speech and swallowing function, and behavioral modification. Outcomes will be assessed at baseline, preoperatively, discharge, and 90 days post-surgery. Data will be analyzed on an intention-to-treat basis using appropriate regression and mixed-effects modeling. This study aims to determine whether integrating prehabilitation with ERAS improves physiological reserve, accelerates recovery, and reduces complications compared with standard care in head and neck cancer surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients (18 -70 years) diagnosed with head and neck cancer scheduled for elective Bite composite resections for carcinoma of buccal mucosa in joint clinic.

排除标准

  • 1.Previous head and neck cancer treatment 2.Perioperative chemotherapy 3.Patients undergoing emergency surgery 4.Any condition that prevents patients from undergoing regular exercises- locomotor limitations preluding exercise training adherence to the program 5.Cognitive deterioration preventing adherence to program.

研究者

发起方
Institution
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR RESHMA AMBULKAR

ADVANCE CENTRE FOR TRAINING RESEARCH AND EDUCATION IN CANCER

研究点 (1)

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