跳至主要内容
临床试验/CTRI/2024/10/075839
CTRI/2024/10/075839尚未招募不适用

Outcomes of patients surgically treated for lateral skull base tumours with special reference to quality of life

AIIMS Delhi1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年11月7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
10
试验地点
1
主要终点
Outcomes in terms of residual disease

研究概览

简要总结

• After approval from ethics committee, the study will proceed.

• Patients fitting into the inclusion criteria and exclusion criteria will be recruited after I/W consent.

• A pre surgery evaluation of cranial nerve palsies, facial nerve status, quality of life, speech and swallowing will be done.

• Patient will be followed up 1 week immediately after surgery and then every 6 months. They will be assessed in the same manner as preoperatively.

• Patients retrospectively recruited will be contacted telephonically and followed up subsequently every 6 months.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients with lateral skull base tumors who have been surgically treated over the past 10 years (Retrospective cohort)
  • Patients with lateral skull base tumors who will be surgically operated till June 2025 (prospective cohort)
  • Patients and attendants consenting for inclusion in the study.

排除标准

  • Patients with neurological deficits unrelated to lateral skull base tumors.
  • Patients and attendants not giving consent for the study.

结局指标

主要结局

Outcomes in terms of residual disease

时间窗: Prospective - at the time of surgery, 1 week and every 6 months. | Retrospective - at the time of recruitment and every 6 months.

Quality of life

时间窗: Prospective - at the time of surgery, 1 week and every 6 months. | Retrospective - at the time of recruitment and every 6 months.

Speech and swallowing outcomes

时间窗: Prospective - at the time of surgery, 1 week and every 6 months. | Retrospective - at the time of recruitment and every 6 months.

Cranial nerve function

时间窗: Prospective - at the time of surgery, 1 week and every 6 months. | Retrospective - at the time of recruitment and every 6 months.

次要结局

  • Retrospective - To compare preoperative & postoperative quality of life in patients(At the time of recruitment & every 6 months.)

研究者

发起方
AIIMS Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Simran Chaudhary

AIIMS Delhi

研究点 (1)

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