Evaluation of Indocyanine Green Angiography Versus Clinical Judgment in Reducing Flap Necrosis and Postoperative Morbidity in Pectoralis Major Myocutaneous Flap Reconstruction for Head and Neck Cancer A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
研究概览
简要总结
Head and neck cancer surgeries often involve removing parts of the face or mouth and reconstructing them using tissue flaps. One commonly used technique in India is the pectoralis major myocutaneous (PMMC) flap, which is reliable and cost-effective. However, poor blood flow in parts of the flap can lead to serious complications such as tissue death, wound breakdown, infection, or the need for repeat surgery. These issues can delay recovery and postpone important treatments like radiotherapy.
Traditionally, surgeons assess flap blood supply during surgery using their clinical judgment—by checking color, bleeding, and temperature. These methods are highly subjective and depend on the surgeon’s experience. As a result, they sometimes fail to detect poorly perfused (low blood flow) areas of the flap.
This study introduces Indocyanine Green Fluorescence Angiography (ICG-A), a modern imaging technique that provides real-time, objective visualization of blood flow. ICG is a dye that, when injected into the bloodstream, fluoresces under infrared light. Using a specialized camera, surgeons can see exactly which areas of the flap have good or poor blood supply. This helps them make more accurate decisions about which tissue to keep and which to revise during the operation.
By comparing traditional methods with ICG-A in a randomized trial, this study aims to evaluate whether ICG-A can reduce complications, improve flap survival, and support faster postoperative recovery, such as earlier feeding, shorter hospital stays, and timely start of radiotherapy.
If successful, this research could help make surgeries safer and more effective, especially in Indian hospitals where PMMC flaps are commonly used, and lead to wider adoption of ICG technology in reconstructive 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 75.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Age greater than eighteen years and less than seventy five years.
- •2.Histologically confirmed squamous cell carcinoma of the oral cavity.
- •3.Planned for PMMC flap reconstruction after resection.
- •4.No known allergy to iodides or ICG dye.
- •5.Willing to provide informed consent.
排除标准
- •1.Recurrent and Non-resectable head and neck cancers 2.Need for free flap reconstruction.
- •3.Prior chest wall surgeries or radiation.
- •4.Patient not fit for surgery 5.Patient not giving consent for participation in this study 6.Patients with diseases with poor healing rates and immunocompromised status 7.Known allergy to iodine or ICG.
- •8.severe hepatic dysfunction, pregnant/lactating women.
研究者
Dr Shridhar Hosamani
AIIMS Mangalagiri
