HysterectomyTLH-BisectionNCT04904822
Abdominal Versus Vaginal Bisection in Laparoscopic Hysterectomy
A study testing Vaginal bisection and Abdominal bisection in people with Hysterectomy and Laparoscopy, run by Tanta University at 1 site in Egypt.
Trial summary
Large uteri present a challenge during Total lap.hysterectomy and its extraction is another challenge. This study addressees and compare 2 methods of retrieval of large uteri Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Hysterectomy, Laparoscopy, Uterine Bisection
- What is being tested?
- Vaginal bisection and Abdominal bisection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 31 Jan 2024
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- large uterus ≥ 12weeks,
- benign pathology,
- mobile uterus
- BMI less than 30kg/m2
Who cannot join
- unfit for laparoscopy,
- Extensive pelvic adhesions,
- Extensive endometriosis
- malignancy
- virgin cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Abdominal Versus Vaginal Uterine Bisection for Retrieval of Large Uteri During Laparoscopic Hysterectomy: A Randomized Controlled Study
Large uteri present a challenge during Total lap.hysterectomy and its extraction is another challenge. This study addressees and compare 2 methods of retrieval of large uteri
Read the detailed description
Despite a number of publications about TLH for large uterus, few surgeons have compared the results of their technique of TLH through the vagina or abdominal bisection. The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or abdominal bisection approaches after strict preoperative assessment.
- Conditions
- Hysterectomy, Laparoscopy, Uterine Bisection, Large Uteri
- Being tested
- Vaginal bisection, Abdominal bisection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal bisectionProcedure or surgery
Uterine bisection vaginally by scalpel 24
Abdominal bisectionProcedure or surgery
Uterine bisection by endokinfe
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Vaginal bisection of uterus Receives: Procedure: Vaginal bisection |
| Control group | Experimental | Abdominal bisection Receives: Procedure: Abdominal bisection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrieval time of uterus
Time from end of colpotomy to extraction of uterus
Measured: 6 months
Blood loss
Amount of blood in suction
Measured: 6 months
Secondary outcomes (1)
Injury of other organs
Number of cases with intraoperative injuries
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Jun 2021
- Primary completion31 Oct 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 2 groups parallel allocation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904822
- Sponsor's protocol ID
- uterine bisection
- Acronym
- TLH-Bisection
- Status last verified
- Mar 2024
- First submitted
- 24 May 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we will share results and statistical analysis on valuable request
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Versus Vaginal Uterine Bisection for Retrieval of Large Uteri During Laparoscopic Hysterectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04904822
- Acronym / sponsor ID
- TLH-Bisection / uterine bisection
- Conditions
- Hysterectomy, Laparoscopy, Uterine Bisection, Large Uteri
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 27 May 2021 (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.
Large uteri present a challenge during Total lap.hysterectomy and its extraction is another challenge. This study addressees and compare 2 methods of retrieval of large uteri
Detailed description
Despite a number of publications about TLH for large uterus, few surgeons have compared the results of their technique of TLH through the vagina or abdominal bisection. The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or abdominal bisection approaches after strict preoperative assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups parallel allocation
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Vaginal bisectionVaginal bisection of uterus |
| Control group | Experimental | Procedure: Abdominal bisectionAbdominal bisection |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- large uterus ≥ 12weeks,
- benign pathology,
- mobile uterus
- BMI less than 30kg/m2
Key exclusion criteria (5 listed)
- unfit for laparoscopy,
- Extensive pelvic adhesions,
- Extensive endometriosis
- malignancy
- virgin cases
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 bisectionUterine bisection vaginally by scalpel 24 | Procedure or surgery | Study group |
| Abdominal bisectionUterine bisection by endokinfe | Procedure or surgery | Control group |
Primary outcome
Retrieval time of uterus
Time frame: 6 months
Time from end of colpotomy to extraction of uterus
Blood loss
Time frame: 6 months
Amount of blood in suction
1 secondary outcome
Injury of other organs
Time frame: 6 months
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 13 Mar 2024.
- Individual participant dataSharing planned: Yes. we will share results and statistical analysis on valuable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 bisection and Abdominal bisection in people with Hysterectomy and Laparoscopy, run by Tanta 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 4 inclusion and 5 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 13 Mar 2024. 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?
Retrieval time of uterus (time frame: 6 months). 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 13 Mar 2024.