Epidemiology of uterine fibroids: a systematic review.
E A Stewart, C L Cookson, R A Gandolfo...
https://pubmed.ncbi.nlm.nih.gov/28296146/Actively Recruiting
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-03-14
82
Participants Needed
4
Research Sites
N/A
Total Duration
Researchers are evaluating the effectiveness of temporarily clipping the uterine artery and utero-ovarian ligament during robotically assisted myomectomy RAM for women with uterine fibroids. Uterine fibroids are common non-cancerous tumors that can cause heavy bleeding, pain, or infertility. While RAM is increasingly used for fibroid removal, controlling bleeding during surgery remains challenging. This randomized controlled trial aims to assess blood loss, need for transfusion, and hemoglobin changes, along with complications and operation time. The study compares two groups one receiving temporary clipping of the uterine arteries and utero-ovarian ligaments using laparoscopic clips during RAM, and the other undergoing RAM without this clipping. The procedure involves temporarily blocking blood flow to reduce bleeding. Both groups undergo robotically assisted myomectomies, and the clipping technique has been studied previously in conventional laparoscopy but not yet in RAM. Participants will be monitored for blood loss during surgery, hemoglobin levels, and any need for blood transfusions within one week. Secondary assessments include operation duration, hospital stay length, complication rates, postoperative pain, and use of additional bleeding control methods. The total follow-up includes monitoring for complications up to six weeks after surgery, ensuring detailed evaluation of safety and surgical outcomes.
CONDITIONS
Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial
S
Stefan Timmerman, MD
W
Wouter Froyman, MD, PhD
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Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
Amsterdam UMC, location VUmc
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 1 day
Participants undergo robotically-assisted myomectomy with or without temporary clipping of the uterine arteries and the utero-ovarian ligaments to control bleeding during surgery.
1 surgical visit (in-person)
Duration - up to 6 weeks
Participants are monitored for post-operative complications, hospitalisation time, and recovery after surgery.
approximately 3 follow-up visits
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/22714065/Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
Amsterdam UMC, location VUmc
Collaborating Sponsor