Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer
Primary Purpose
Uterine Bleeding
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vaginal hysterectomy
Laparoscopic hysterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Bleeding focused on measuring Vaginal hysterectomy, Laparoscopic hysterectomy
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.
Sites / Locations
- Mansoura University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Vaginal hysterectomy
Laparoscopic hysterectomy
Arm Description
Removal of uterus through vagina in absence of prolapse
Key hole surgery through small incisions of the abdomen
Outcomes
Primary Outcome Measures
Duration of operation
Duration of operation
Secondary Outcome Measures
Time of requiring analgesics
The time of the first request for analgesics
Number of requiring analgesics
The number of requests for analgesics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04237558
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
February 22, 2022 (Actual)
Study Completion Date
April 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Bleeding
Keywords
Vaginal hysterectomy, Laparoscopic hysterectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
comparison between laparoscopic hysterectomy versus non-descent vaginal hysterectomy using bipolar vessel sealers in patients with abnormal uterine bleeding
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaginal hysterectomy
Arm Type
Active Comparator
Arm Description
Removal of uterus through vagina in absence of prolapse
Arm Title
Laparoscopic hysterectomy
Arm Type
Active Comparator
Arm Description
Key hole surgery through small incisions of the abdomen
Intervention Type
Procedure
Intervention Name(s)
Vaginal hysterectomy
Intervention Description
Vaginal hysterectomy by removal of uterus through vagina in absence of prolapse
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic hysterectomy
Intervention Description
Laparoscopic hysterectomy through key hole surgery through small incisions of the abdomen
Primary Outcome Measure Information:
Title
Duration of operation
Description
Duration of operation
Time Frame
From start of surgery up to 24 hours
Secondary Outcome Measure Information:
Title
Time of requiring analgesics
Description
The time of the first request for analgesics
Time Frame
Until 24 hours postoperatively
Title
Number of requiring analgesics
Description
The number of requests for analgesics
Time Frame
Until 24 hours postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amany A Makroum, MSc
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Hospital
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer
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