Blocking both uterine arteries during laparoscopic fibroid removal
Comparing Different Techniques of Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy: A Randomized Controlled Trial
This will test whether temporarily or permanently blocking both uterine arteries during laparoscopic fibroid removal reduces bleeding and affects ovarian reserve in reproductive-age women having myomectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | Female |
| Sponsor | Alexandria University Academic / other |
| Locations | 2 sites (Alexandria, El-Shatby and 1 other locations) |
| Trial ID | NCT07352761 on ClinicalTrials.gov |
What this trial studies
Reproductive-age women with up to three fibroids (3–10 cm) scheduled for laparoscopic myomectomy will be randomized in a single-blind, controlled design at two gynecologic centers in Alexandria, Egypt. Participants are allocated to one of four arms: temporary arterial clipping, temporary shoe-lace suture occlusion, bipolar coagulation, or no uterine artery occlusion before myomectomy. The primary outcomes are intraoperative blood loss and change in postoperative hemoglobin; secondary outcomes include the time to perform the occlusion procedure and postoperative measures of ovarian reserve. Results across groups will determine whether occlusion techniques reduce surgical bleeding and whether they have measurable effects on ovarian function.
Who should consider this trial
Good fit: Women of reproductive age with 1–3 uterine fibroids measuring 3–10 cm who are scheduled for laparoscopic myomectomy and have not had recent hormonal treatment or prior ovarian surgery are ideal candidates.
Not a fit: Women with BMI > 30, prior midline abdominal incisions, ≥4 fibroids, submucous fibroids requiring hysteroscopic resection, suspected malignancy, or those better suited for hysterectomy are excluded and unlikely to benefit from these procedures.
Why it matters
Potential benefit: If successful, these occlusion techniques could reduce intraoperative blood loss and the need for transfusion during laparoscopic myomectomy while preserving ovarian function.
How similar studies have performed: Previous reports of uterine artery occlusion or transient devascularization generally show reduced intraoperative blood loss, but evidence on long-term effects on ovarian reserve is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * women with uterine fibroids and complaining of either abnormal uterine bleeding, infertility, urinary or rectosigmoid pressure manifestations. * Fibroid size from 3 - 10 cm in diameter and with * a maximum number of 3 fibroids. Exclusion Criteria: * contraindication to pneumoperitoneum and laparoscopy, * patients with BMI \> 30 kg/m2, * history of midline abdominal incisions, * women with history of prior ovarian surgery, * women with history of hormonal treatment for the last 3 months before surgery, * women who are not good candidate for myomectomy and who would benefit more from hysterectomy such as, women with multiple ≥ 4 leiomyomata, associated adenomyosis, recurrent fibroids after myomectomy. * suspected endometrial malignancy or suspected leiomyosarcoma features on ultrasound and/or MRI. * Submucous fibroids who will undergo hysteroscopic myomectomy beside the laparoscopic surgery.
Where this trial is running
Alexandria, El-Shatby and 1 other locations
- Department of Obstetrics and Gynecology, Faculty of Medicine, Alexandria Univeristy — Alexandria, El-Shatby, Egypt (Recruiting)
- • Al-Madina Women Hospital, A specialized hospital of Obstetrics and Gynecology, Alexandria, Egypt. — Alexandria, Smouha, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed Shoukry, MD/PhD
- Email: a_shokry17@alexmed.edu.eg
- Phone: 0201024586399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.