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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04237558
Enrollment
52
Registered
2020-01-23
Start date
2020-04-01
Completion date
2022-04-28
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Bleeding

Keywords

Vaginal hysterectomy, Laparoscopic hysterectomy

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.

Interventions

PROCEDUREVaginal hysterectomy

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

PROCEDURELaparoscopic hysterectomy

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

comparison between laparoscopic hysterectomy versus non-descent vaginal hysterectomy using bipolar vessel sealers in patients with abnormal uterine bleeding

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Duration of operationFrom start of surgery up to 24 hoursDuration of operation

Secondary

MeasureTime frameDescription
Time of requiring analgesicsUntil 24 hours postoperativelyThe time of the first request for analgesics
Number of requiring analgesicsUntil 24 hours postoperativelyThe number of requests for analgesics

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026