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

Uterine Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237558
• Other study ID #: AM1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: April 28, 2022

Study information

• Verified date: September 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 28, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Uterine Bleeding
• Uterine Hemorrhage

Intervention

Procedure:
• Vaginal hysterectomy
Vaginal hysterectomy by removal of uterus through vagina in absence of prolapse
• Laparoscopic hysterectomy
Laparoscopic hysterectomy through key hole surgery through small incisions of the abdomen

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of operation	Duration of operation	From start of surgery up to 24 hours
Secondary	Time of requiring analgesics	The time of the first request for analgesics	Until 24 hours postoperatively
Secondary	Number of requiring analgesics	The number of requests for analgesics	Until 24 hours postoperatively