Uterine Artery InjuryNCT04522232
Laparoscopic Hysterectomy With Prior Uterine Artery Ligation
A study testing conventional Total laparoscopic hysterectomy and Total laparoscopic hysterectomy with prior uterine artery ligation at its origin in people with Uterine Artery Injury and Hysterectomy, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
A randomized controlled trial was done on 127 women planned for TLH, and divided into two groups; group A includes women that underwent conventional TLH, and group B includes women that underwent TLH with prior uterine artery ligation at its origin. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Artery Injury, Hysterectomy
- What is being tested?
- conventional Total laparoscopic hysterectomy and Total laparoscopic hysterectomy with prior uterine artery ligation at its origin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to 31 May 2020
- 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- fibroid uterus
- endometrial hyperplasia with failed hormonal therapy
- DUB with failed medical and hormonal treatment
- uterine prolapse.
Who cannot join
- gynecologic malignancy
- presence of contraindications to laparoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Hysterectomy With Prior Uterine Artery Ligation vs Conventional Laparoscopic Hysterectomy
A randomized controlled trial was done on 127 women planned for TLH, and divided into two groups; group A includes women that underwent conventional TLH, and group B includes women that underwent TLH with prior uterine artery ligation at its origin. Both grouped were compared regarding the blood loss, operation time, intraoperative complications and post-operative follow-up.
- Conditions
- Uterine Artery Injury, Hysterectomy
- Being tested
- conventional Total laparoscopic hysterectomy, Total laparoscopic hysterectomy with prior uterine artery ligation at its origin
- Keywords
- Hysterectomy, Laparoscopy, Uterine Artery Ligation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional Total laparoscopic hysterectomyProcedure or surgery
the ascending branch of the uterine artery was identified close to the isthmus then ligated at this level, close to the uterus or coagulated, using bipolar diathermy. The utero-vesical fold was dissected and the bladder was pushed down done, thus moving the ureters laterally, which decreases the risk of including them in a suture. The vasculature of the uterus is now secured and this is evidenced by the pale color of the fundus.
Using either bipolar diathermy or the harmonic ultracision, the cornual pedicles on one side were desiccated and cut. Also, both the uterosacral and cardinal ligaments were desiccated and cut. So that, the opposite side pedicles can be taken care of, the direction of manipulator was changed. The infundibulopelvic ligaments were desiccated and cut if it is necessary to remove both ovaries. A vaginal cuff was inserted into the vagina to identify the vault, which was then cut laparoscopically using a monopolar hook, where the specimen was completely detached.
Total laparoscopic hysterectomy with prior uterine artery ligation at its originProcedure or surgery
the uterine artery was dissected using the lateral approach; where dissection begins from the anterior leaf of the broad ligament. The triangle enclosed by the round ligament, external iliac artery, and infundibulopelvic ligament was opened. The areolar space was dissected and the origin of the uterine artery from the internal iliac and the ureter was identified. The uterine artery was then isolated from the surrounding structures and ligated by Hem-o-lok clips.
then same steps as conventional Total laparoscopic hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| group A | Placebo comparator | women that underwent conventional Total laparoscopic hysterectomy Receives: Procedure: conventional Total laparoscopic hysterectomy |
| group B | Experimental | women that underwent Total laparoscopic hysterectomy with prior uterine artery ligation at its origin Receives: Procedure: Total laparoscopic hysterectomy with prior uterine artery ligation at its origin |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
The total blood loss was calculated from the suction apparatus. No irrigation was used throughout the surgery until the total blood loss was calculated. Peritoneal lavage was done with normal saline solution.
Measured: during the Laparoscopy
operation time
start time is the insertion of 10 mm telescope trocar end-time is the removal of all trocars
Measured: during the Laparoscopy
Secondary outcomes (1)
intraoperative or postoperative complications
intraoperative complications are that during the Laparoscopy postoperative complications are that during the hospital stay (24 hours postoperative)
Measured: during the Laparoscopy and during the hospital stay (24 hours postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Dec 2017
- Primary completion29 Feb 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Artery InjuryStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Helwan University, Cairo University, Al-Azhar University
- Responsible party
- Principal investigator, Mazen Abdel Rasheed, National Research Centre, Egypt
- Investigators
- Mazen Abdel-Rasheed, Principal investigator, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522232
- Sponsor's protocol ID
- Uterine artery ligation in TLH
- Status last verified
- Oct 2022
- First submitted
- 17 Aug 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Hysterectomy With Prior Uterine Artery Ligation vs Conventional Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT04522232
- Acronym / sponsor ID
- Uterine artery ligation in TLH
- Conditions
- Uterine Artery Injury, Hysterectomy
- Keywords
- Hysterectomy, Laparoscopy, Uterine Artery Ligation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Collaborators
- Helwan University, Cairo University, Al-Azhar University
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 21 Aug 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.
A randomized controlled trial was done on 127 women planned for TLH, and divided into two groups; group A includes women that underwent conventional TLH, and group B includes women that underwent TLH with prior uterine artery ligation at its origin. Both grouped were compared regarding the blood loss, operation time, intraoperative complications and post-operative follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Placebo comparator | Procedure: conventional Total laparoscopic hysterectomywomen that underwent conventional Total laparoscopic hysterectomy |
| group B | Experimental | Procedure: Total laparoscopic hysterectomy with prior uterine artery ligation at its originwomen that underwent Total laparoscopic hysterectomy with prior uterine artery ligation at its origin |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- fibroid uterus
- endometrial hyperplasia with failed hormonal therapy
- DUB with failed medical and hormonal treatment
- uterine prolapse.
Key exclusion criteria (2 listed)
- gynecologic malignancy
- presence of contraindications to laparoscopy.
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 |
|---|---|---|
| conventional Total laparoscopic hysterectomythe ascending branch of the uterine artery was identified close to the isthmus then ligated at this level, close to the uterus or coagulated, using bipolar diathermy. The utero-vesical fold was dissected and the bladder was pushed down done, thus moving the ureters laterally, which decreases the risk of including them in a suture. The vasculature of the uterus is now secured and this is evidenced by the pale color of the fundus. Using either bipolar diathermy or the harmonic ultracision, the cornual pedicles on one side were desiccated and cut. Also, both the uterosacral and cardinal ligaments were desiccated and cut. So that, the opposite side pedicles can be taken care of, the direction of manipulator was changed. The infundibulopelvic ligaments were desiccated and cut if it is necessary to remove both ovaries. A vaginal cuff was inserted into the vagina to identify the vault, which was then cut laparoscopically using a monopolar hook, where the specimen was completely detached. | Procedure or surgery | group A |
| Total laparoscopic hysterectomy with prior uterine artery ligation at its originthe uterine artery was dissected using the lateral approach; where dissection begins from the anterior leaf of the broad ligament. The triangle enclosed by the round ligament, external iliac artery, and infundibulopelvic ligament was opened. The areolar space was dissected and the origin of the uterine artery from the internal iliac and the ureter was identified. The uterine artery was then isolated from the surrounding structures and ligated by Hem-o-lok clips. then same steps as conventional Total laparoscopic hysterectomy | Procedure or surgery | group B |
Primary outcome
blood loss
Time frame: during the Laparoscopy
The total blood loss was calculated from the suction apparatus. No irrigation was used throughout the surgery until the total blood loss was calculated. Peritoneal lavage was done with normal saline solution.
operation time
Time frame: during the Laparoscopy
start time is the insertion of 10 mm telescope trocar end-time is the removal of all trocars
1 secondary outcome
intraoperative or postoperative complications
Time frame: during the Laparoscopy and during the hospital stay (24 hours postoperative)
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 4 Oct 2022.
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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.
Mazen Abdel-Rasheed principal investigator
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional Total laparoscopic hysterectomy and Total laparoscopic hysterectomy with prior uterine artery ligation at its origin in people with Uterine Artery Injury and Hysterectomy, run by National Research Centre, Egypt 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 4 inclusion and 2 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 4 Oct 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. Some participants in this study may receive a placebo. 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?
blood loss (time frame: during the Laparoscopy). The study lists 2 primary outcomes in all. 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 4 Oct 2022.