Hysterectomy, Benign Uterine DiseasesNCT07330102
Systematic Approach for Cold Knife Morcellation of Large Uterus in Total Laparoscopic Hysterectomy
A study testing Morcellation in people with Hysterectomy, Benign Uterine Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysterectomy, Benign Uterine Diseases
- What is being tested?
- Morcellation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2025to 29 Dec 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women candidates for total laparoscopic hysterectomy
- Uterus size >/= 20 weeks gravid uterus
- Benign uterine disease
Who cannot join
- • Malignant or premalignant uterine disease
- Bleeding disorders
- Unfit for surgery
- Contraindications for laparoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri. The cervix is guided through the colpotomy and is grasped vaginally with a tenaculum and pulled exteriorly. The vault is then closed with a continuous suture.
Read the detailed description
Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri. The cervix is guided through the colpotomy and is grasped vaginally with a tenaculum and pulled exteriorly. The vault is then closed with a continuous suture.
- Conditions
- Hysterectomy, Benign Uterine Diseases
- Being tested
- Morcellation
- Keywords
- Hysterectomy, Morcellation, Large uterus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorcellationProcedure or surgery
Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri.
| Study group | Role | What they receive |
|---|---|---|
| Morecellation group | Experimental | Morcellation of the large uterus Receives: Procedure: Morcellation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of operation
Total time of the operation
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start2 Jul 2025
- Primary completion29 Dec 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysterectomy, Benign Uterine DiseasesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Model description
- Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330102
- Sponsor's protocol ID
- 368
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Approach for Cold Knife Morcellation of Large Uterus in Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT07330102
- Acronym / sponsor ID
- 368
- Conditions
- Hysterectomy, Benign Uterine Diseases
- Keywords
- Hysterectomy, Morcellation, Large uterus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 9 Jan 2026 (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 the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri. The cervix is guided through the colpotomy and is grasped vaginally with a tenaculum and pulled exteriorly. The vault is then closed with a continuous suture.
Detailed description
Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri. The cervix is guided through the colpotomy and is grasped vaginally with a tenaculum and pulled exteriorly. The vault is then closed with a continuous suture.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Following the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri.
| Arm | Type | Receives |
|---|---|---|
| Morecellation group | Experimental | Procedure: MorcellationMorcellation of the large uterus |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women candidates for total laparoscopic hysterectomy
- Uterus size >/= 20 weeks gravid uterus
- Benign uterine disease
Key exclusion criteria (4 listed)
- • Malignant or premalignant uterine disease
- Bleeding disorders
- Unfit for surgery
- Contraindications for 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 |
|---|---|---|
| MorcellationFollowing the completion of the TLH and before vault closure, the uterus is flipped upside down to resemble a flask and is grasped by the assistant from the cervix. The endoknife is advanced carefully through a 10 mm trocar and an incision is started from the level of the isthmus and advanced sagittally towards the fundus to bisect this uterus into two hemiuteri connected at the fundus. The incision is stopped 1-2 cm before the fundus to keep the specimen intact. The uterus (which is grasped from the cervix) is then rotated 90 degrees and another incision is started in the hemiuterus containing the cervix coronally towards the fundus again bisecting this hemiuterus. The incision is advanced through the connecting fundus bisecting the other hemiuterus. The incision is stopped 1-2 cm before the specimen is split into two. The end result is a long, connected strip of uterus formed of the bisected hemiuteri. | Procedure or surgery | Morecellation group |
Primary outcome
Time of operation
Time frame: At time of surgery
Total time of the operation
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 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Maged principal investigator
Cairo 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 Morcellation in people with Hysterectomy, Benign Uterine Diseases, run by Cairo 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 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 9 Jan 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?
Time of operation (time frame: At time of surgery). 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 9 Jan 2026.