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Clinical Trials/NCT04237558
NCT04237558
Completed
Not Applicable

Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer in Mansoura University Hospitals: A Randomized Clinical Trial

Mansoura University1 site in 1 country52 target enrollmentApril 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uterine Bleeding
Sponsor
Mansoura University
Enrollment
52
Locations
1
Primary Endpoint
Duration of operation
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study will be a randomized clinical trial to evaluate the surgical performance and outcome of total laparoscopic hysterectomy compared to non-descent vaginal hysterectomy ,using bipolar vessel sealer,in cases of abnormal uterine bleeding in Mansoura University Hospital in order to reach the optimum technique for our locality

Detailed Description

Hysterectomy is the surgical removal of the uterus. It is the commonest major gynecological surgery, next to caesarean section, with millions of procedures performed annually throughout the world.Approximately 90% of hysterectomies are performed for benign conditions. Although there are many approaches to hysterectomy, which depend on clinical criteria, certain patients may be eligible to be operated in any of the several available approaches. The optimal route of hysterectomy for a patient will depend on the pathological nature, size and shape of the vagina and uterus, uterine descent, endometriosis and the likelihood of pelvic adhesions, adnexal masses, previous pelvic surgery, available hospital technology, devices and the surgeon's preference. Approaches to hysterectomy may be broadly categorized into four options: abdominal hysterectomy (AH); vaginal hysterectomy (VH); laparoscopic hysterectomy (LH) where at least some of the operation is conducted laparoscopically and robotic-assisted hysterectomy (RH).Vaginal and laparoscopic procedures are considered "minimally invasive" surgical approaches because they do not require a large abdominal incision and, thus, typically are associated with shortened hospitalization and postoperative recovery times compared with open abdominal hysterectomy. This study will be a randomized clinical trial to evaluate the surgical performance and outcome of total laparoscopic hysterectomy compared to non-descent vaginal hysterectomy, using bipolar vessel sealer, in cases of abnormal uterine bleeding in order to reach the optimum technique with lower cost to be easily applied to low resource settings.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
April 28, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women assigned for performing hysterectomy for abnormal uterine bleeding due to benign pathology.
  • Uterine size by bimanual examination ≤14 weeks gestational size.
  • Cases with uterine volumes ≤ 400cm3 will be included in this study.

Exclusion Criteria

  • Patients with BMI \> 30kg/m2
  • Uteri \> 14 weeks gestational size by bimanual examination or volume \> 400cm3
  • Women with positive pap smear for CIN or endometrial biopsy with atypia or carcinoma.
  • Patient with other known body malignancy.
  • Patient with other pelvic pathology, endometriosis or pelvic abscesses.
  • Patients with abdominal scars.

Outcomes

Primary Outcomes

Duration of operation

Time Frame: From start of surgery up to 24 hours

Duration of operation

Secondary Outcomes

  • Time of requiring analgesics(Until 24 hours postoperatively)
  • Number of requiring analgesics(Until 24 hours postoperatively)

Study Sites (1)

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