Gynecologic DiseaseNCT06875518
Comparative Study of Blood Loss in Total Laparoscopic Hysterectomy by Ligation the Uterine Arteries in Different Techniques.
A study testing BTLH with bilateral uterine artery ligation from its origin and Conventional TLH in people with Gynecologic Disease, run by Mostafa Bahaa at 1 site in Egypt.
Trial summary
Following Caesarean section, hysterectomy is the second most common major gynecological surgery, with approximately 600,000 procedures performed annually in the USA. Since Reich et al. first reported a total laparoscopic hysterectomy (TLH) in 1989, numerous studies have confirmed its feasibility and reproducibility. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- BTLH with bilateral uterine artery ligation from its origin and Conventional TLH
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2025to 20 Jun 2025
- 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
- Patients aged between 35-60 years Patients presented with menometrorrhagia unresponsive to medical treatment, and uterine pathology such as adenomyosis or multiple fibroids.
Who cannot join
- Patients were excluded if they had: medical conditions preventing pneumo-peritoneum
- Patients with medical conditions hindering proper ventilation during general anesthesia.
- Patients diagnosed with endometrial carcinoma and patients with uterine size larger than 24 weeks were excluded.
- Patients with excessive adhesions precluding access to the uterine arteries were not enrolled in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Following Caesarean section, hysterectomy is the second most common major gynecological surgery, with approximately 600,000 procedures performed annually in the USA. Since Reich et al. first reported a total laparoscopic hysterectomy (TLH) in 1989, numerous studies have confirmed its feasibility and reproducibility. Evidence increasingly supports TLH over vaginal hysterectomy (VH) and total abdominal hysterectomy (TAH) for benign gynecological conditions. The development and rapid advancement of laparoscopic instruments and techniques have enabled the safe and successful completion of complex procedures using minimally invasive approaches. Women with a higher BMI or requiring complex surgeries benefit from reduced postoperative complications with laparoscopic operations.
- Conditions
- Gynecologic Disease
- Being tested
- BTLH with bilateral uterine artery ligation from its origin, Conventional TLH
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTLH with bilateral uterine artery ligation from its originProcedure or surgery
The round ligament close to the pelvic side wall is first coagulated and separated before the procedure is applied. Further incision is then made in the peritoneum. The bladder fold is pulled downward by opening the anterior leaf of the wide ligament. It shows the ureters lateralized and the posterior leaf of the wide ligament. After that, the ureters' path is shown, the retroperitoneal area is revealed, and the location where the uterine artery leaves the iliac artery is seen.
Conventional TLHProcedure or surgery
The conventional TLH technique involved division of the corneal pedicles and securing the uterine pedicles. Preoperative Preparation of bowel wasn't routinely done to improve enhanced recovery of patients. Antibiotic prophylaxis with 3rd generation cephalosporin and metronidazole was given one hour preoperatively. Obese patients received subcutaneous low molecular weight heparin and compression devices after surgery. Under general anesthesia, patients were placed in a Lloyd Davis position.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Group 1 (BTLH with bilateral uterine artery ligation from its origin): The round ligament close to the pelvic side wall is first coagulated and separated before the procedure is applied. Receives: Procedure: BTLH with bilateral uterine artery ligation from its origin |
| Conventional TLH | Active comparator | The conventional TLH technique involved division of the corneal pedicles and securing the uterine pedicles. Preoperative Preparation of bowel wasn't routinely done to improve enhanced recovery of patients. Receives: Procedure: Conventional TLH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra operative blood loss
Vaginal vault is identified and cut laparoscopically using monopolar hook over the manipulator cup and bipolar grasper for hemostasis until the specimen is detached completely. The uterus with cervix is delivered vaginally. The vaginal vault is sutured laparoscopically with number 1 delayed absorbable suture (Polyglactin; vicryl).
The total blood loss is calculated from the suction apparatus.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start12 Mar 2025
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mostafa Bahaa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875518
- Sponsor's protocol ID
- 8749
- Status last verified
- May 2026
- First submitted
- 9 Mar 2025
- Last updated
- 4 May 2026
- 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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Blood Loss in Total Laparoscopic Hysterectomy by Ligation the Uterine Arteries in Different Techniques.
- ClinicalTrials.gov ID
- NCT06875518
- Acronym / sponsor ID
- 8749
- Conditions
- Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mostafa BahaaUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 13 Mar 2025 (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.
Following Caesarean section, hysterectomy is the second most common major gynecological surgery, with approximately 600,000 procedures performed annually in the USA. Since Reich et al. first reported a total laparoscopic hysterectomy (TLH) in 1989, numerous studies have confirmed its feasibility and reproducibility. Evidence increasingly supports TLH over vaginal hysterectomy (VH) and total abdominal hysterectomy (TAH) for benign gynecological conditions. The development and rapid advancement of laparoscopic instruments and techniques have enabled the safe and successful completion of complex procedures using minimally invasive approaches. Women with a higher BMI or requiring complex surgeries benefit from reduced postoperative complications with laparoscopic operations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: BTLH with bilateral uterine artery ligation from its originGroup 1 (BTLH with bilateral uterine artery ligation from its origin): The round ligament close to the pelvic side wall is first coagulated and separated before the procedure is applied. |
| Conventional TLH | Active comparator | Procedure: Conventional TLHThe conventional TLH technique involved division of the corneal pedicles and securing the uterine pedicles. Preoperative Preparation of bowel wasn't routinely done to improve enhanced recovery of patients. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged between 35-60 years Patients presented with menometrorrhagia unresponsive to medical treatment, and uterine pathology such as adenomyosis or multiple fibroids.
Key exclusion criteria (4 listed)
- Patients were excluded if they had: medical conditions preventing pneumo-peritoneum
- Patients with medical conditions hindering proper ventilation during general anesthesia.
- Patients diagnosed with endometrial carcinoma and patients with uterine size larger than 24 weeks were excluded.
- Patients with excessive adhesions precluding access to the uterine arteries were not enrolled in the study.
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 |
|---|---|---|
| BTLH with bilateral uterine artery ligation from its originThe round ligament close to the pelvic side wall is first coagulated and separated before the procedure is applied. Further incision is then made in the peritoneum. The bladder fold is pulled downward by opening the anterior leaf of the wide ligament. It shows the ureters lateralized and the posterior leaf of the wide ligament. After that, the ureters' path is shown, the retroperitoneal area is revealed, and the location where the uterine artery leaves the iliac artery is seen. | Procedure or surgery | Control group |
| Conventional TLHThe conventional TLH technique involved division of the corneal pedicles and securing the uterine pedicles. Preoperative Preparation of bowel wasn't routinely done to improve enhanced recovery of patients. Antibiotic prophylaxis with 3rd generation cephalosporin and metronidazole was given one hour preoperatively. Obese patients received subcutaneous low molecular weight heparin and compression devices after surgery. Under general anesthesia, patients were placed in a Lloyd Davis position. | Procedure or surgery | Conventional TLH |
Primary outcome
Intra operative blood loss
Time frame: 24 hours
Vaginal vault is identified and cut laparoscopically using monopolar hook over the manipulator cup and bipolar grasper for hemostasis until the specimen is detached completely. The uterus with cervix is delivered vaginally. The vaginal vault is sutured laparoscopically with number 1 delayed absorbable suture (Polyglactin; vicryl). The total blood loss is calculated from the suction apparatus.
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 May 2026.
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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 BTLH with bilateral uterine artery ligation from its origin and Conventional TLH in people with Gynecologic Disease, run by Mostafa Bahaa 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 1 inclusion and 4 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 May 2026. 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?
Intra operative blood loss (time frame: 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 4 May 2026.