Clinical trial NCT04237558: Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer
Official title: Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer in Mansoura University Hospitals: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Bleeding
Keywords: Vaginal hysterectomy
Laparoscopic hysterectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 52
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparison between laparoscopic hysterectomy versus non-descent vaginal hysterectomy using bipolar vessel sealers in patients with abnormal uterine bleeding
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Duration of operation
timeFrame: From start of surgery up to 24 hours
Secondary outcomes:
measure: Time of requiring analgesics
timeFrame: Until 24 hours postoperatively
measure: Number of requiring analgesics
timeFrame: Until 24 hours postoperatively
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Amany A Makroum, MSc
role: PRINCIPAL_INVESTIGATOR
References: