Total Laparoscopic HysterectomyNCT07774871
Routine Versus Selective Ureterolysis During Total Laparoscopic Hysterectomy for Benign Conditions
A study testing Routine Ureterolysis and Selective Ureterolysis in people with Total Laparoscopic Hysterectomy, run by ClinAmygate at 1 site in Egypt.
Trial summary
To evaluate whether routine ureterolysis during Total Laparoscopic Hysterectomy for benign gynecologic conditions affects operative efficiency and perioperative safety compared with a selective ureterolysis approach. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Total Laparoscopic Hysterectomy
- What is being tested?
- Routine Ureterolysis and Selective Ureterolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Aug 2026to 28 Apr 2027
- 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 35-70 years
- Scheduled for TLH for benign indications:
- Symptomatic fibroids, Abnormal uterine bleeding, Adenomyosis, Endometrial hyperplasia, Pelvic organ prolapse requiring hysterectomy, Chronic pelvic pain, Uterine size ≤16 weeks
Who cannot join
- Previous pelvic radiation
- Known ureteric abnormalities or pathology
- Severe cardiopulmonary disease precluding laparoscopy
- Inability to provide informed consent
- Known retroperitoneal pathology
- Emergency surgery
- Uterine size > 16 weeks
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
Kasr Alaini gynecology and obstetrics hospital
Cairo, Cairo Governorate, 11472
Mostafa MA Saad, MSc, +201006744717, mostafa.saad.gyn@gmail.com
About this study
Official title: Routine Versus Selective Ureterolysis During Total Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial of Operative Efficiency and Perioperative Safety
To evaluate whether routine ureterolysis during Total Laparoscopic Hysterectomy for benign gynecologic conditions affects operative efficiency and perioperative safety compared with a selective ureterolysis approach.
Read the detailed description
Hysterectomy is one of the most commonly performed major gynecological procedures worldwide, with approximately 600,000 procedures performed annually in the United States alone and similar rates observed globally when adjusted for population size.1 Over the past two decades, there has been a paradigm shift in surgical approach, with minimally invasive techniques, particularly total laparoscopic hysterectomy (TLH), increasingly replacing traditional open surgery.2 This transition has been driven by compelling evidence demonstrating significant advantages of the laparoscopic approach, including reduced postoperative pain, shorter hospital stays, faster return to normal activities, improved cosmetic outcomes, and lower overall morbidity compared to abdominal hysterectomy.2
Ureteric injury represents one of the most serious potential complications during TLH which occurs in 0.2 to 6 % of cases due to the close anatomical relation with the ureter, which is higher than abdominal hysterectomy in which ureteric injury occurs in 0.03 to 2 % of cases.3 Ureteric injury has potentially devastating consequences for patients including renal impairment, prolonged hospitalization, need for additional surgical interventions, and long-term morbidity.4
Ureterolysis during TLH helps to reduce the incidence of ureteric injury.5 Ureterolysis is infrequently practiced by gynecologists however, it is necessary during complex surgery.6 The American Association of Gynecologic Laparoscopists (AAGL) practice guidelines for laparoscopic hysterectomy state that "identification of the ureters should be undertaken when the anatomy is unclear or when risk factors for injury are present," but acknowledge that "some surgeons advocate routine ureterolysis for all laparoscopic hysterectomies.7
Surgeons who perform ureterolysis as a routine approach justify it due to :
- The additional operative time (10-15 minutes) is justified by improved safety.8
- When performed correctly, ureterolysis does not significantly increase risk of direct injury.8
- The technique preserves periureteric blood supply when proper tissue planes are followed.8
- Routine practice ensures surgical proficiency.8
- Patient outcomes are improved when injuries are prevented rather than managed after they occur.8 In this study we aim to compare between routine approach and selective approach for ureterolysis during laparoscopic hysterectomy
- Conditions
- Total Laparoscopic Hysterectomy
- Being tested
- Routine Ureterolysis, Selective Ureterolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine UreterolysisProcedure or surgery
for all cases of the group: After entering the pelvis and before uterine vessel ligation, routine bilateral ureterolysis will be performed. The retroperitoneal space will be opened by incising the peritoneum overlying the ureter, followed by careful blunt and sharp dissection to identify each ureter and trace its course from the pelvic brim toward the uterine artery and ureteric tunnel. Surrounding tissue will be dissected only to the extent necessary to obtain clear visualization and safe lateralization of the ureter before completing the hysterectomy. Excessive skeletonization, thermal spread, and disruption of the ureteral blood supply will be avoided. The procedure will be performed using a standardized technique and documented in the operative record.
Selective UreterolysisProcedure or surgery
for selected cases of the group: After entering the pelvis and before uterine vessel ligation, routine bilateral ureterolysis will be performed. The retroperitoneal space will be opened by incising the peritoneum overlying the ureter, followed by careful blunt and sharp dissection to identify each ureter and trace its course from the pelvic brim toward the uterine artery and ureteric tunnel. Surrounding tissue will be dissected only to the extent necessary to obtain clear visualization and safe lateralization of the ureter before completing the hysterectomy. Excessive skeletonization, thermal spread, and disruption of the ureteral blood supply will be avoided. The procedure will be performed using a standardized technique and documented in the operative record.
| Study group | Role | What they receive |
|---|---|---|
| Routine Ureterolysis | Experimental | Intervention Group: Routine Ureterolysis Receives: Procedure: Routine Ureterolysis |
| Selective Ureterolysis | Active comparator | Control group: selective Ureterolysis Receives: Procedure: Selective Ureterolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total operative duration
Total operative duration in minutes measured from skin incision to skin closure
Measured: day 0
Secondary outcomes (1)
time needed for ureterolysis
Determine time needed for ureterolysis during TLH
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start21 Aug 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Apr 2027 (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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled parallel study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ClinAmygate
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed Ahmed Saad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774871
- Sponsor's protocol ID
- PR-MD-238-2026
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Versus Selective Ureterolysis During Total Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial of Operative Efficiency and Perioperative Safety
- ClinicalTrials.gov ID
- NCT07774871
- Acronym / sponsor ID
- PR-MD-238-2026
- Conditions
- Total Laparoscopic Hysterectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ClinAmygateUniversity, hospital or other
- Study start
- 21 Aug 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Apr 2027 (estimated)
- First posted
- 19 Aug 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.
To evaluate whether routine ureterolysis during Total Laparoscopic Hysterectomy for benign gynecologic conditions affects operative efficiency and perioperative safety compared with a selective ureterolysis approach.
Detailed description
Hysterectomy is one of the most commonly performed major gynecological procedures worldwide, with approximately 600,000 procedures performed annually in the United States alone and similar rates observed globally when adjusted for population size.1 Over the past two decades, there has been a paradigm shift in surgical approach, with minimally invasive techniques, particularly total laparoscopic hysterectomy (TLH), increasingly replacing traditional open surgery.2 This transition has been driven by compelling evidence demonstrating significant advantages of the laparoscopic approach, including reduced postoperative pain, shorter hospital stays, faster return to normal activities, improved cosmetic outcomes, and lower overall morbidity compared to abdominal hysterectomy.2
Ureteric injury represents one of the most serious potential complications during TLH which occurs in 0.2 to 6 % of cases due to the close anatomical relation with the ureter, which is higher than abdominal hysterectomy in which ureteric injury occurs in 0.03 to 2 % of cases.3 Ureteric injury has potentially devastating consequences for patients including renal impairment, prolonged hospitalization, need for additional surgical interventions, and long-term morbidity.4
Ureterolysis during TLH helps to reduce the incidence of ureteric injury.5 Ureterolysis is infrequently practiced by gynecologists however, it is necessary during complex surgery.6 The American Association of Gynecologic Laparoscopists (AAGL) practice guidelines for laparoscopic hysterectomy state that "identification of the ureters should be undertaken when the anatomy is unclear or when risk factors for injury are present," but acknowledge that "some surgeons advocate routine ureterolysis for all laparoscopic hysterectomies.7
Surgeons who perform ureterolysis as a routine approach justify it due to :
- The additional operative time (10-15 minutes) is justified by improved safety.8
- When performed correctly, ureterolysis does not significantly increase risk of direct injury.8
- The technique preserves periureteric blood supply when proper tissue planes are followed.8
- Routine practice ensures surgical proficiency.8
- Patient outcomes are improved when injuries are prevented rather than managed after they occur.8 In this study we aim to compare between routine approach and selective approach for ureterolysis during laparoscopic hysterectomy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled parallel study
| Arm | Type | Receives |
|---|---|---|
| Routine Ureterolysis | Experimental | Procedure: Routine UreterolysisIntervention Group: Routine Ureterolysis |
| Selective Ureterolysis | Active comparator | Procedure: Selective UreterolysisControl group: selective Ureterolysis |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 35-70 years
- Symptomatic fibroids, Abnormal uterine bleeding, Adenomyosis, Endometrial hyperplasia, Pelvic organ prolapse requiring hysterectomy, Chronic pelvic pain, Uterine size ≤16 weeks
Key exclusion criteria (7 listed)
- Previous pelvic radiation
- Known ureteric abnormalities or pathology
- Severe cardiopulmonary disease precluding laparoscopy
- Inability to provide informed consent
- Known retroperitoneal pathology
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 |
|---|---|---|
| Routine Ureterolysisfor all cases of the group: After entering the pelvis and before uterine vessel ligation, routine bilateral ureterolysis will be performed. The retroperitoneal space will be opened by incising the peritoneum overlying the ureter, followed by careful blunt and sharp dissection to identify each ureter and trace its course from the pelvic brim toward the uterine artery and ureteric tunnel. Surrounding tissue will be dissected only to the extent necessary to obtain clear visualization and safe lateralization of the ureter before completing the hysterectomy. Excessive skeletonization, thermal spread, and disruption of the ureteral blood supply will be avoided. The procedure will be performed using a standardized technique and documented in the operative record. | Procedure or surgery | Routine Ureterolysis |
| Selective Ureterolysisfor selected cases of the group: After entering the pelvis and before uterine vessel ligation, routine bilateral ureterolysis will be performed. The retroperitoneal space will be opened by incising the peritoneum overlying the ureter, followed by careful blunt and sharp dissection to identify each ureter and trace its course from the pelvic brim toward the uterine artery and ureteric tunnel. Surrounding tissue will be dissected only to the extent necessary to obtain clear visualization and safe lateralization of the ureter before completing the hysterectomy. Excessive skeletonization, thermal spread, and disruption of the ureteral blood supply will be avoided. The procedure will be performed using a standardized technique and documented in the operative record. | Procedure or surgery | Selective Ureterolysis |
Primary outcome
Total operative duration
Time frame: day 0
Total operative duration in minutes measured from skin incision to skin closure
1 secondary outcome
time needed for ureterolysis
Time frame: day 0
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 19 Aug 2026.
- Individual participant dataSharing planned: No
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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 Routine Ureterolysis and Selective Ureterolysis in people with Total Laparoscopic Hysterectomy, run by ClinAmygate 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 7 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: opening soon, as of the sponsor's last update on 19 Aug 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?
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 Mostfa MA Saad, MSc (+201006744717, mostafa.saad.gyn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total operative duration (time frame: day 0). 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 19 Aug 2026.