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
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
Dr M Sai Rohith
Kasturba medical college
