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临床试验/CTRI/2025/07/091718
CTRI/2025/07/091718尚未招募Phase 3 4

Evaluation and comparision of outcomes of apron incision ( Freund and latyshevsky ) and transverse cervical incision when used for selective neck dissection in patients with oral sqamous cell carcinoma : A Randomised Control Trial

Datta Meghe Institute Of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
22
试验地点
1
主要终点
Surgical accessibility to all the levels of neck maybe better with apron incision than with transverse cervical incision.

研究概览

简要总结

Oral squamous cell carcinoma (OSCC) accounts for the majority of oral cancer cases worldwide, and effective treatment often requires surgical removal of both the primary tumor and affected cervical lymph nodes through neck dissection. The choice of surgical incision plays a crucial role in ensuring adequate exposure, minimizing complications, and achieving satisfactory aesthetic outcomes. While both the apron flap incision (Freund and Latyshevsky) and the transverse cervical incision are commonly used for selective neck dissection, there is limited comparative evidence on their effectiveness. The aim of this study is to systematically evaluate and compare the clinical outcomes of these two incisions in terms of surgical exposure, wound healing, complication rates, and cosmetic results in patients undergoing neck dissection for OSCC.This is a randomised controlled trial which will be conducted in Siddharth Gupta memorial Cancer Hospital, Sawangi, Maharashtra.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients underdoing selective neck dissection for squamous cell carcinoma of oral cavity.

排除标准

  • Patients who has undergone preoperative radiotherapy Patients who exhibit tumors with clinical or radiological skin involvement Patients who refuse to provide written consent.

结局指标

主要结局

Surgical accessibility to all the levels of neck maybe better with apron incision than with transverse cervical incision.

时间窗: Surgical accessibility to neck will be assessed intraoperatively on the day of surgery that is baseline Day 0

次要结局

  • Wound healing & post operative scar maybe better with transverse cervical incision than with apron incision(Wound healing will be assessed by the end of 1 week & 2nd week posoperatively)

研究者

发起方
Datta Meghe Institute Of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Sindhoora N

Datta Meghe Institute Of Higher Education and Research

研究点 (1)

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