Comparision of Radial Forearm Free Flap and Pectoralis Major Myocutaneous Pedicle Flap in maxillofacial oncologiacl defect in view of esthetics, functional outcome,feeding tube dependency ,mouth opening and quality of life post surgery A randomised control
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- to examine donor site complications ,esthetics and functional outcome and quality of life
研究概览
简要总结
this is a prospective, randomized, parallel-group, active-controlled clinical trial conducted to compare the outcomes of Radial Forearm Free Flap and Pectoralis Major Myocutaneous Flap for reconstruction of maxillofacial oncologic defects. A total of 36 patients will be randomly allocated in a 1:1 ratio to either reconstruction technique using computer-generated randomization with sealed opaque envelope allocation. Blinding will be applied to the outcome assessor and investigator. The primary outcome will be flap survival, defined as complete viability of the reconstructive flap without total flap loss within 30 days, 60 days and 90days postoperatively. Secondary outcomes include postoperative complications, feeding tube dependency, swallowing assessment ,speech, mouth opening, esthetic outcome, and donor site morbidity. Outcome assessment will be performed intraoperatively, during the immediate postoperative period, at 30 days,60 days,90 days interval postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •patient with oral squamous cell carcinoma proven by biopsy, planned for single stage resection and soft tissue flap reconstruction.
排除标准
- •Patients not available for complete follow-up during the postoperative assessment period.
- •Patients with collagen disorders and haematological disorders.
- •Negative Allens test (for case of RFAFF cases only) -Patients with history of previous surgery, radiation or chemotherapy in head and neck region.
结局指标
主要结局
to examine donor site complications ,esthetics and functional outcome and quality of life
时间窗: 1 month,3 month and 6 month post operatively
次要结局
- Functional outcomes(-Speech (using an assessment scale))
研究者
Dr Upasa Sarma Medhi
INSTITUTE OF DENTAL SCIENCES, SIKSHA O ANUSANDHAN
