Total Laparoscopic HysterectomyNCT06867614
Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy
A study testing Total laparoscopic hysterectomy in people with Total Laparoscopic Hysterectomy, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the laparoscopic and transvaginal closure techniques of the vaginal vault in patients who perform TLH, regarding the risk of vaginal vault hematoma and other complications as vaginal cuff infection and sexual dysfunction. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Total Laparoscopic Hysterectomy
- What is being tested?
- Total laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2025to 19 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult females consenting to do TLH all age groups with diagnoses of benign uterine conditions.
- Women who are non-obese (normal or overweight women with BMI range 18-29.9).
- Sexually active female.
Who cannot join
- Diagnosed cases of pelvic malignancy
- Diagnosed patients with Cervical intraepithelial neoplasia (CIN) or bacterial vaginosis (any infection should be treated)
- Obese patients.
- Patients currently undergoing treatment for any type of cancer
- Patients with coagulopathy, bleeding/clotting disorders
- Patients with any condition can impair wound healing: diabetes mellites, anemia, steroids
- Patients with a previous history of radiation and allergy to sutures
- Patients with clinically evident prolapse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University maternity hospital
Cairo
About this study
Official title: Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy - a Single Blinded Randomized Comparative Study
The goal of this clinical trial is to compare the laparoscopic and transvaginal closure techniques of the vaginal vault in patients who perform TLH, regarding the risk of vaginal vault hematoma and other complications as vaginal cuff infection and sexual dysfunction.
- Conditions
- Total Laparoscopic Hysterectomy
- Being tested
- Total laparoscopic hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total laparoscopic hysterectomyProcedure or surgery
Removal of uterus and cervix by laparoscope
| Study group | Role | What they receive |
|---|---|---|
| Vaginal approach | Active comparator | Closure of vaginal vault after delivery of the specimen by vaginal suturing Receives: Procedure: Total laparoscopic hysterectomy |
| Laparoscopic approach | Active comparator | Closure of vaginal vault after delivery of the specimen by laparoscopic suturing Receives: Procedure: Total laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Vault hematoma
It will be assessed by examination and ultrasound
Measured: From 10 days postoperative to 30 days postoperative
Secondary outcomes (5)
Bleeding/spotting
I wil be assed by history and examination
Measured: From 10 days postoperative to 30 days postoperative
Vaginal infection:
It will be assessed by history and examination
Measured: From 10 days postoperative to 30 days postoperative
Vaginal prolapse
It will be assessed by history and examination
Measured: From 10 days postoperative to 30 days postoperative
Vaginal cuff granulation
It will be assessed by examination and ultrasound
Measured: From 10 days postoperative to 30 days postoperative
Sexual dysfunction
I will be assessed through Female Sexual Function Index (FSFI) questionnaire
Measured: From 3 to 4 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start14 Jan 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion19 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Laparoscopic HysterectomyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rowan Ashraf AbdelHady Sakr, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867614
- Sponsor's protocol ID
- FMASU MS 34/2025
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2025
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy - a Single Blinded Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06867614
- Acronym / sponsor ID
- FMASU MS 34/2025
- Conditions
- Total Laparoscopic Hysterectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 19 Jan 2026 (estimated)
- First posted
- 10 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.
The goal of this clinical trial is to compare the laparoscopic and transvaginal closure techniques of the vaginal vault in patients who perform TLH, regarding the risk of vaginal vault hematoma and other complications as vaginal cuff infection and sexual dysfunction.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal approach | Active comparator | Procedure: Total laparoscopic hysterectomyClosure of vaginal vault after delivery of the specimen by vaginal suturing |
| Laparoscopic approach | Active comparator | Procedure: Total laparoscopic hysterectomyClosure of vaginal vault after delivery of the specimen by laparoscopic suturing |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult females consenting to do TLH all age groups with diagnoses of benign uterine conditions.
- Women who are non-obese (normal or overweight women with BMI range 18-29.9).
- Sexually active female.
Key exclusion criteria (8 listed)
- Diagnosed cases of pelvic malignancy
- Diagnosed patients with Cervical intraepithelial neoplasia (CIN) or bacterial vaginosis (any infection should be treated)
- Obese patients.
- Patients currently undergoing treatment for any type of cancer
- Patients with coagulopathy, bleeding/clotting disorders
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 |
|---|---|---|
| Total laparoscopic hysterectomyRemoval of uterus and cervix by laparoscope | Procedure or surgery | Laparoscopic approach, Vaginal approach |
Primary outcome
Vaginal Vault hematoma
Time frame: From 10 days postoperative to 30 days postoperative
It will be assessed by examination and ultrasound
5 secondary outcomes
Bleeding/spotting
Time frame: From 10 days postoperative to 30 days postoperative
Vaginal infection:
Time frame: From 10 days postoperative to 30 days postoperative
Vaginal prolapse
Time frame: From 10 days postoperative to 30 days postoperative
Vaginal cuff granulation
Time frame: From 10 days postoperative to 30 days postoperative
Sexual dysfunction
Time frame: From 3 to 4 months post operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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Postoperative Pain Following Total Laparoscopic Hysterectomy
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Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total laparoscopic hysterectomy in people with Total Laparoscopic Hysterectomy, run by Ain Shams 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 8 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: looking for participants now, as of the sponsor's last update on 10 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rowan A Sakr (+201026141345, 150232@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Vault hematoma (time frame: From 10 days postoperative to 30 days postoperative). 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 10 Mar 2025.