- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07330102
Systematic Approach for Cold Knife Morcellation of Large Uterus in Total Laparoscopic Hysterectomy
December 29, 2025 updated by: Ahmed M Maged, MD, Cairo University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 12111
- Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Women candidates for total laparoscopic hysterectomy
- Uterus size >/= 20 weeks gravid uterus
- Benign uterine disease
Exclusion Criteria:
- • Malignant or premalignant uterine disease
- Bleeding disorders
- Unfit for surgery
- Contraindications for laparoscopy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Morecellation group
Morcellation of the large uterus
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time of operation
Time Frame: At time of surgery
|
Total time of the operation
|
At time of surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmed Maged, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 2, 2025
Primary Completion (Actual)
December 29, 2025
Study Completion (Actual)
December 29, 2025
Study Registration Dates
First Submitted
December 29, 2025
First Submitted That Met QC Criteria
December 29, 2025
First Posted (Actual)
January 9, 2026
Study Record Updates
Last Update Posted (Actual)
January 9, 2026
Last Update Submitted That Met QC Criteria
December 29, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 368
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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