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Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer

M

Mansoura University

Status

Completed

Conditions

Uterine Bleeding

Treatments

Procedure: Vaginal hysterectomy
Procedure: Laparoscopic hysterectomy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

52 patients

Sex

Female

Ages

35 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Vaginal hysterectomy
Active Comparator group
Description:
Removal of uterus through vagina in absence of prolapse
Treatment:
Procedure: Vaginal hysterectomy
Laparoscopic hysterectomy
Active Comparator group
Description:
Key hole surgery through small incisions of the abdomen
Treatment:
Procedure: Laparoscopic hysterectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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