Uterine BleedingNCT04237558
Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer
A study testing Vaginal hysterectomy and Laparoscopic hysterectomy in people with Uterine Bleeding, run by Mansoura University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Uterine Bleeding
- What is being tested?
- Vaginal hysterectomy and Laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 28 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
About this study
Official title: 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
Read the 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.
- Conditions
- Uterine Bleeding
- Being tested
- Vaginal hysterectomy, Laparoscopic hysterectomy
- Keywords
- Vaginal hysterectomy, Laparoscopic hysterectomy
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal hysterectomyProcedure or surgery
Vaginal hysterectomy by removal of uterus through vagina in absence of prolapse
Laparoscopic hysterectomyProcedure or surgery
Laparoscopic hysterectomy through key hole surgery through small incisions of the abdomen
| Study group | Role | What they receive |
|---|---|---|
| Vaginal hysterectomy | Active comparator | Removal of uterus through vagina in absence of prolapse Receives: Procedure: Vaginal hysterectomy |
| Laparoscopic hysterectomy | Active comparator | Key hole surgery through small incisions of the abdomen Receives: Procedure: Laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of operation
Duration of operation
Measured: From start of surgery up to 24 hours
Secondary outcomes (2)
Time of requiring analgesics
The time of the first request for analgesics
Measured: Until 24 hours postoperatively
Number of requiring analgesics
The number of requests for analgesics
Measured: Until 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Apr 2020
- Primary completion22 Feb 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine BleedingStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amany A Makroum, MSc, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237558
- Sponsor's protocol ID
- AM1
- Status last verified
- Sep 2022
- First submitted
- 26 Jul 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer in Mansoura University Hospitals: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04237558
- Acronym / sponsor ID
- AM1
- Conditions
- Uterine Bleeding
- Keywords
- Vaginal hysterectomy, Laparoscopic hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparison between laparoscopic hysterectomy versus non-descent vaginal hysterectomy using bipolar vessel sealers in patients with abnormal uterine bleeding
| Arm | Type | Receives |
|---|---|---|
| Vaginal hysterectomy | Active comparator | Procedure: Vaginal hysterectomyRemoval of uterus through vagina in absence of prolapse |
| Laparoscopic hysterectomy | Active comparator | Procedure: Laparoscopic hysterectomyKey hole surgery through small incisions of the abdomen |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal hysterectomyVaginal hysterectomy by removal of uterus through vagina in absence of prolapse | Procedure or surgery | Vaginal hysterectomy |
| Laparoscopic hysterectomyLaparoscopic hysterectomy through key hole surgery through small incisions of the abdomen | Procedure or surgery | Laparoscopic hysterectomy |
Primary outcome
Duration of operation
Time frame: From start of surgery up to 24 hours
Duration of operation
2 secondary outcomes
Time of requiring analgesics
Time frame: Until 24 hours postoperatively
Number of requiring analgesics
Time frame: Until 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amany A Makroum, MSc principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal hysterectomy and Laparoscopic hysterectomy in people with Uterine Bleeding, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of operation (time frame: From start of surgery up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.