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

Not Applicable

Completed

• Conditions: Uterine Bleeding
• Interventions: Procedure: Laparoscopic hysterectomy; Procedure: Vaginal hysterectomy

• Registration Number: NCT04237558
• Lead Sponsor: Mansoura University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2020-01-21
• Study First Posted: 2020-01-23
• Study Start: 2020-04-01
• Primary Completion: 2022-02-22
• Study Completion: 2022-04-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic hysterectomy	Laparoscopic hysterectomy	Key hole surgery through small incisions of the abdomen
Vaginal hysterectomy	Vaginal hysterectomy	Removal of uterus through vagina in absence of prolapse

Primary Outcome Measures

Name	Time	Method
Duration of operation	From start of surgery up to 24 hours	Duration of operation

Secondary Outcome Measures

Name	Time	Method
Time of requiring analgesics	Until 24 hours postoperatively	The time of the first request for analgesics
Number of requiring analgesics	Until 24 hours postoperatively	The number of requests for analgesics

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt