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

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

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

Study Overview

• Status: Completed
• Conditions: Uterine Bleeding
• Intervention / Treatment: Procedure: Vaginal hysterectomy; Procedure: Laparoscopic hysterectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35111
      • Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vaginal hysterectomy; Removal of uterus through vagina in absence of prolapse	Procedure: Vaginal hysterectomy; Vaginal hysterectomy by removal of uterus through vagina in absence of prolapse
Active Comparator: Laparoscopic hysterectomy; Key hole surgery through small incisions of the abdomen	Procedure: Laparoscopic hysterectomy; Laparoscopic hysterectomy through key hole surgery through small incisions of the abdomen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of operation	Duration of operation	From start of surgery up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of requiring analgesics	The time of the first request for analgesics	Until 24 hours postoperatively
Number of requiring analgesics	The number of requests for analgesics	Until 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Amany A Makroum, MSc, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: January 21, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Vaginal hysterectomy; Laparoscopic hysterectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: AM1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No