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Trial registered on ANZCTR


Registration number
ACTRN12624001424594
Ethics application status
Approved
Date submitted
16/09/2024
Date registered
5/12/2024
Date last updated
5/12/2024
Date data sharing statement initially provided
5/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Role of Laparoscopic Uterine Artery Clipping in Refractory Abnormal Uterine Bleeding Related to Benign Causes
Scientific title
Role of Laparoscopic Uterine Artery Clipping in Refractory Abnormal Uterine Bleeding Related to Benign Causes in Women Age 35-55 (A Prospective Intervention study)
Secondary ID [1] 312928 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
irregular uterine bleeding due to benign caused 335091 0
gynecological bleeding 335092 0
Condition category
Condition code
Reproductive Health and Childbirth 331591 331591 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
laparoscopic uterine artery ligation in cases of irregular uterine bleeding due to benign causes .The patient is placed in low lithotomy position using Allen stirrups. After establishment of pneumoperitoneum and introduction of the first optic trocar through the umbilicus , the patient is put in Trendelenburg position of approximately 25 degrees. Maximal intrabdominal pressure is set to 12–13 mmHg. Two ancillary 5-mm trocars are inserted in each iliac fossa under direct vision lateral to the inferior epigastric vessels and one ancillary 10–12 mm trocar is inserted in the suprapubic area. Scissors, bipolar overhold. A uterine manipulator will be introduced, and laparoscopy will be performed using a 10-mm 0-degree laparoscope inserted using the open technique through an umbilical incision to primary port. Using monopolar diathermy (90 W cutting current and 60 W coagulation) with micro scissors and graspers, the peritoneum of the anterior leaf of the right broad ligament, between the round ligament and the infundibulopelvic ligament, will be incised. Ask the assistant to pull the infudibulopelvic ligament medially in more cephalic position to open the space. Extend the incision cephalic till the level of sacral promontory (the bifurcation of two common iliac arteries). Then gentle sweeping between external iliac artery towards the infundibulopelvic ligament to expose the ureter. the ureter which is the first key once seen, by gentle sweeping technique open the lateral pararectal space (dissection parallel to the ureter by one grasper and medialization of ureter by the other). Once the lateral pararectal space is opened, you will be able to see the internal iliac artery, just follow the direction and dissect over the obliterated umbilical artery which is the second key. Then grasp the obliterated umbilical artery and pull it up while asking the assistant to keep the space opened. This pulling technique will allow to see the vascular tree of the pelvis with clear vision of the uterine artery which is the first branch of anterior division of internal iliac artery which cross the lateral pararectal space from lateral to medial crossing above the ureter (water under bridge) and take care there may be a branch from the internal iliac cross the space also but passing to the ureter not above which is the ureteric branch. As the uterine artery still covered by fascia and for more safe clipping, dissect the medial Para vesical space above the uterine artery .so, you can clearly see the uterine artery which is the border between lateral pararectal and medial Para vesical space. You can now grasp uterine artery itself, dissect the artery from fascia below to avoid injury of the deep uterine vein, uterine artery will be isolated and permanently occluded with Liga clips Yasargil vascular clips and then coagulated. The procedure will be then repeated on the left side. The investigator is the surgeon . It will be done once in the setting
The procedure will be done in the minimally invasive unit in department of Obstetrics and Gynecology. The approximate duration of the procedure is 45 - 55 minutes .
counseling of patient about the details of procedure and postoperative follow up
Intervention code [1] 329458 0
Treatment: Surgery
Comparator / control treatment
NO control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339381 0
the ability of uterine artery clipping to control bleeding
Timepoint [1] 339381 0
after 6 months postoperative in comparison with baseline preoperative
Primary outcome [2] 339744 0
change quality of life
Timepoint [2] 339744 0
after 6 months postoperative in comparison with baseline preoperative
Secondary outcome [1] 439722 0
Avoidance of hysterectomy
Timepoint [1] 439722 0
6 months post surgery

Eligibility
Key inclusion criteria
1. Abnormal uterine bleeding not responding to medical and hormonal treatment.
2. Age group 35-55 years.
3. Patients who refuse hysterectomy options.
4. Benign gynecological disease [e.g. small fibroid uterus, adenomyosis, chronic pelvic pain, endometriosis].
5. Uterine size not more than 16 weeks.
Minimum age
35 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with uterine size more than 16 weeks
2. Evidence of any gynecological malignancy
3. If the patient refused to participate.
4. Extremes of age.
5. Future fertility needs (seeking pregnancy).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size calculation was performed using GPower software version 3.1.9.6 (Franz Faul, Universität Kiel, Germany), based on the results of our pilot study with 10 patients who had refractory abnormal uterine bleeding and underwent bilateral laparoscopic uterine artery clipping. The pilot study reported a mean pre-operative hemoglobin level of 10.5 ± 1 g/dL, a 3-month post-operative level of 11.2 ± 1.2 g/dL and effect size of 0.63. To detect a significant difference with a statistical power of 95% and a significance level (a) of 0.05, the required sample size was 90 patients . To account for potential dropouts, the sample size was increased by 10% in each group resulting in a final sample size of 100 patients.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2025
Actual
Date of last participant enrolment
Anticipated
15/01/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 26562 0
Egypt
State/province [1] 26562 0
Minia city

Funding & Sponsors
Funding source category [1] 317358 0
Self funded/Unfunded
Name [1] 317358 0
Country [1] 317358 0
Primary sponsor type
Hospital
Name
Maternity and children hospital faculty of medicine Minia University
Address
Country
Egypt
Secondary sponsor category [1] 319648 0
None
Name [1] 319648 0
Address [1] 319648 0
Country [1] 319648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316089 0
ethical board faculty of Medicine Minia University
Ethics committee address [1] 316089 0
Ethics committee country [1] 316089 0
Egypt
Date submitted for ethics approval [1] 316089 0
02/09/2024
Approval date [1] 316089 0
09/09/2024
Ethics approval number [1] 316089 0
1277

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136750 0
Prof Reham Elkhateeb
Address 136750 0
Minia University, Damaris, Second Al Minya, Minya Governorate 2431436, Egypt .
Country 136750 0
Egypt
Phone 136750 0
+201011966648
Fax 136750 0
Email 136750 0
rehamelkhateeb78@yahoo.com
Contact person for public queries
Name 136751 0
Ayman Ndy
Address 136751 0
Minia University, Damaris, Second Al Minya, Minya Governorate 2431436, Egypt .
Country 136751 0
Egypt
Phone 136751 0
+201003622245
Fax 136751 0
Email 136751 0
elnadyayman7074@yahoo.com
Contact person for scientific queries
Name 136752 0
Mohmad Salah
Address 136752 0
Minia University, Damaris, Second Al Minya, Minya Governorate 2431436, Egypt .
Country 136752 0
Egypt
Phone 136752 0
+201026236578
Fax 136752 0
Email 136752 0
salah1991@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
primary outcome and secondary outcome results
the data of published results only
When will data be available (start and end dates)?
available one year after publication after 15/12/2025
Available to whom?
any one wishes to access it
Available for what types of analyses?
scientific analysis
How or where can data be obtained?
Email the principal investigator
rehamelkhateeb78@yahoo.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.