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Completed

NCT Number: NCT04237558

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

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

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Key information

Age range

35 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaginal hysterectomy

Procedure

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

laparoscopic hysterectomy

Procedure

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

Primary outcomes

  1. Duration of operation

    Time frame: From start of surgery up to 24 hours

    Duration of operation

Secondary outcomes

  1. Time of requiring analgesics

    Time frame: Until 24 hours postoperatively

    The time of the first request for analgesics

  2. Number of requiring analgesics

    Time frame: Until 24 hours postoperatively

    The number of requests for analgesics

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 23, 2020
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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