跳至主要内容
临床试验/CTRI/2025/08/092908
CTRI/2025/08/092908尚未招募4 期

Negative versus neutral drainage systems in patients following head and neck surgery- A randomised control study

All India Institute of Medical Sciences New Delhi1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
96
试验地点
1
主要终点
Immediate postoperative quality of life in neutral and negative suction groups

研究概览

简要总结

Surgical drains are now a routine part of postoperative management in major head and neck surgeries. Based on their mechanism of action, drains are broadly classified into negative pressure (active suction) systems and neutral pressure (passive or gravity-based) systems. While negative suction drains are considered effective in reducing fluid collections, minimising dead space, and possibly decreasing infection risk, their application in complex oral cancer surgeries—where tissue integrity is delicate and direct communication with the aero-digestive tract is common—remains debatable. In surgeries involving communication between the oral cavity and neck, or where only thin tissue layers separate compartments, negative pressure drains may pose risks such as tissue compression, microvascular compromise, and suture line dehiscence. Our study aims to address this gap by comparing postoperative hospital course and outcomes in two groups of patients managed with either negative or neutral drainage systems

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1 Adult patients with age 18 to 60 years 2 Patients with oral and oropharyngeal malignancies anticipated to have neck communication during resection 3 Parents willing to sign informed consent.

排除标准

  • 1 Patients with early stage malignancies where oral and oropharyngeal parts will not be communicated with neck 2 Patients with other site malignancies 3 Prior radio or chemotherapy.

结局指标

主要结局

Immediate postoperative quality of life in neutral and negative suction groups

时间窗: drain output will be measured on day 1, 2, 3, 4, 5, 6, 7 and 8 postoperatively

次要结局

  • Postoperative complications in the negative & neutral suction groups.(will be seen on postoperative day 1, day 8 & day 14)

研究者

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Hitesh Verma

All India Institute of Medical Sciences, New Delhi

研究点 (1)

Loading locations...

相似试验