跳至主要内容
临床试验/CTRI/2026/01/101156
CTRI/2026/01/101156尚未招募不适用

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

SIKSHA O ANUSANDHAN1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年2月13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
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

发起方
SIKSHA O ANUSANDHAN
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Upasa Sarma Medhi

INSTITUTE OF DENTAL SCIENCES, SIKSHA O ANUSANDHAN

研究点 (1)

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