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临床试验/CTRI/2024/06/069030
CTRI/2024/06/069030尚未招募不适用

Effectiveness of Total Laparoscopic Hysterectomy versus Non-descent Vaginal Hysterectomy in women with benign uterine pathologies: A Randomized Controlled Trial

Department of Obstetrics and Gynaecology1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2024年6月25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
132
试验地点
1
主要终点
1. Quantitative measure of blood loss intra-operatively

研究概览

简要总结

**Introduction:**The ideal hysterectomy procedure should be minimally invasive, have low morbidity, low health care costs, shorten the length of the hospital stay, and improve patient satisfaction. Therefore, the current study’s objective is to assess and compare the clinical results of two alternative hysterectomy approaches namely Total Laparoscopic Hysterectomy (TLH) and Non-Descent Vaginal Hysterectomy (NDVH).

Methodology: A total of 132 women with benign uterine pathologies will be randomized by computer-generated randomization and a sequentially numbered, sealed opaque envelope method will be used for allocation in this single-blinded parallel-group randomized controlled trial. Group A (study group) will be the patients undergoing TLH and Group B (control group) will be the patients undergoing NDVH.

Result: The blood loss in each group will be calculated using a quantitative method of measuring blood loss intraoperatively. The operation time will be noted and the pain at the suture site will be noted immediately post-surgery and on day 2 of the surgery using the Visual Analog Scale. The statistical analysis will include descriptive and inferential analysis to determine the significant difference.

Conclusion: The present study will be comparing and concluding the

effectiveness of TLH and NDVH in women with benign uterine pathologies. This will explore the outcome of the surgery in terms of recovery, morbidity, and cost-effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Diagnosis of benign uterine pathologies.
  • Uterine size not surpassing 16 weeks of gravid uterus size, with sufficient uterine mobility.
  • Those willing to provide informed consent.

排除标准

  • Genital neoplasm, cancer, or malignancy
  • Any adnexal pathology
  • Acute pelvic inflammatory disease
  • Uterine prolapse– stage II and above
  • Those who had any medical issues that could have been made worse by pneumoperitoneum or the Trendelenburg position.

结局指标

主要结局

1. Quantitative measure of blood loss intra-operatively

时间窗: Immediately post-surgery and on day 2 post surgery

2. Post-operative pain using the Visual Analog Scale

时间窗: Immediately post-surgery and on day 2 post surgery

次要结局

  • Not applicable(Not applicable)

研究者

发起方
Department of Obstetrics and Gynaecology
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Abhishek Sonkusare

NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital

研究点 (1)

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