Comparison of Types of Hysterectomy on Womens Life
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Primary outcome of the study is to find out preferred type of hysterectomy on the basis of the various demographic characteristics and the various questionnaires that are being given to the participants of the study.
研究概览
简要总结
Hysterectomy is one of the most commonly performed surgeries in gynaecology practice. The majority of hysterectomies are performed for benign indications. It is estimated that one in every three women will undergo a hysterectomy at some point in her life. We will be investigation various hysterectomy techniques and determine their influence on patient outcomes like pain levels, anxiety, sexual function and quality of life. This study is unique in its comprehensive evaluation i.e. considering recovery times, patient satisfaction, and various other aspects. This study is unique as such type of study has not been carried out in recent times comparing surgical procedures with its pre and post operative effect on a patient’s life. Various details from the patients undergoing hysterectomy will be collected. Pre-operative anxiety will be scored using Hamilton Anxiety Scale (HAM-A), immediate post-operative pain score will be calculated using Visual Analogue Scale(VAS) and Post-operatively at 2 months follow-up patient will be given SF-36 score to see the quality of life after hysterectomy and at 6 months, on telephonic follow-up FSFI (Female Sexual function index) for measuring changes over time before and after interventions in sexual function of a female and SF-36 (Quality of Life) will be calculated and compared among the 3 study groups - TAH (Total abdominal hysterectomy), LAPAROSCOPIC HYSTERECTOMY and NDVH (Non descendent vaginal hysterectomy). On comparison, preferred mode of hysterectomy will be found out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females between 40 to 75 years who understand and give informed consent Diagnosed with benign conditions requiring hysterectomy as a treatment option.
排除标准
- •Exclusion criteria.
- •Patient who have not consented for the study.
- •Patients who opted for medical management.
- •Patients with suspected malignancy.
结局指标
主要结局
Primary outcome of the study is to find out preferred type of hysterectomy on the basis of the various demographic characteristics and the various questionnaires that are being given to the participants of the study.
时间窗: Primary outcome of the study is to find out preferred type of hysterectomy on the basis of the various demographic characteristics and the various questionnaires that are being given to the participants of the study. Questionnaires will be given to patient prior to surgery to assess the anxiety of the patient, immediate post surgery to assess the pain, to assess the quality of life after 2 months and 6 months and sexual function will be assessed after 6 months.
次要结局
未报告次要终点
研究者
Dr Bhanu Sharma
Kasturba Medical College, Manipal