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

NCT ID: NCT04237558

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2022-04-28

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.

Conditions

Uterine Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vaginal hysterectomy

Removal of uterus through vagina in absence of prolapse

Group Type: ACTIVE_COMPARATOR

Vaginal hysterectomy

Intervention Type: PROCEDURE

Vaginal hysterectomy by removal of uterus through vagina in absence of prolapse

Laparoscopic hysterectomy

Key hole surgery through small incisions of the abdomen

Group Type: ACTIVE_COMPARATOR

Laparoscopic hysterectomy

Intervention Type: PROCEDURE

Laparoscopic hysterectomy through key hole surgery through small incisions of the abdomen

Interventions

Vaginal hysterectomy

Vaginal hysterectomy by removal of uterus through vagina in absence of prolapse

Intervention Type: PROCEDURE

Laparoscopic hysterectomy

Laparoscopic hysterectomy through key hole surgery through small incisions of the abdomen

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amany A Makroum, MSc

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

AM1

Identifier Type: -

Identifier Source: org_study_id