跳至主要内容
临床试验/CTRI/2025/02/080314
CTRI/2025/02/080314尚未招募不适用

Prospective observational and comparative study utilizing VEINES QOL/SYM questionnaire to assess health related quality of life following patient undergoing radio frequency ablation and Trendelenburg surgery for varicose veins

未提供1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2026年1月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
103
试验地点
1
主要终点
This study helps in better understanding of the effect of the individual

研究概览

简要总结

It is a prospective observational study which will

be conducted at Kasturba Medical College Manipal Academy of Higher Education, Manipal.

After attaining clearance from the Institutional Ethics Committee and informed consent from

patient, patients who are clinical and radiologically diagnosed with varicose veins and

admitted in the Dept of General Surgery, KMC Manipal, for the varicose veins surgery

Trendelenburg surgery or RFA during the time period of March 2024 to September 2025. The

type of surgery that the patient undergoes will be determined by the operating surgeon and

the relevant team. This research project will have no bearing over the choice of surgery that

the patient undergoes. Patients that consent to participating in the study and meet the

inclusion criteria will be divided into groups based on the type of procedure RFA or

trendelenburg that they are planned to undergo will be approached prior to the surgery and

patient will be explained about the study and about the VEINES QOL/SYM questionnaire. The

recruited subject will be given half an hour to complete the questionnaire.The VEINES

QOL/SYM questionnaire will be administered to recruited patients preoperatively.All recruited

patients will be asked to repeat the same questionnaire postoperatively at 1 month, 3 months

and 6 months (follow-up in OPD as per routine standard of care, or telephonically or via email

if the patient does not visit the OPD for follow-up). Data collected will be analyzed to assess

the change in quality of life and symptom severity as reported by the patients in the VEINES

QOL/SYM questionnaire recorded preoperatively, and at 1 month, 3 months and 6 months

post-operatively, and this will be compared between the two groups RFA and Trendelenburg procedure

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients undergoing surgical procedure for varicose veins at Kasturba Hospital, Manipal Patient willing and able to provide Written informed consent.
  • Patients more than 18 years of age.

排除标准

  • pregnant females Patients below 18 years Secondary and Recurrent varicose veins.

结局指标

主要结局

This study helps in better understanding of the effect of the individual

时间窗: 1month , 3months and 6months

procedures on the health related quality of life in the individual undergoing RFA and

时间窗: 1month , 3months and 6months

Trendelenburg on health related quality of life in an individual with varicose veins

时间窗: 1month , 3months and 6months

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr M Sai Rohith

Kasturba medical college

研究点 (1)

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