Effectiveness of Total Laparoscopic Hysterectomy versus Non-descent Vaginal Hysterectomy in women with benign uterine pathologies: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- 1. Quantitative measure of blood loss intra-operatively
Study Overview
Brief Summary
**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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 35.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1. Quantitative measure of blood loss intra-operatively
Time Frame: Immediately post-surgery and on day 2 post surgery
2. Post-operative pain using the Visual Analog Scale
Time Frame: Immediately post-surgery and on day 2 post surgery
Secondary Outcomes
- Not applicable(Not applicable)
Investigators
Dr Abhishek Sonkusare
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital