Randomized Trial of Intrauterine Balloon Placement to Prevent Adhesions After Hysteroscopic Septum Removal

What This Trial Is About

Researchers are studying the best way to prevent internal scar tissue called intrauterine adhesions after surgery to remove a uterine septum. The trial compares the use of an intrauterine foley catheter balloon placed after hysteroscopic septoplasty to hormonal supplementation alone. This open-label, randomized controlled trial focuses on individuals undergoing planned septum resection with a septum length of 50% or more of the uterine cavity. Participants will be randomly assigned to one of two groups one group will have an intrauterine pediatric foley catheter balloon placed during surgery and left in place for 7 to 10 days, along with hormonal therapy the other group will receive hormonal therapy only without catheter placement. Surgical techniques may vary by surgeon preference. Postoperative care includes a 3D saline sonogram within the first two menstrual cycles, but no later than 12 weeks after surgery, to check for adhesions. During the study, participants will be assessed for adhesion formation and any intraoperative or postoperative complications up to 12 weeks following surgery. Hormonal therapy adherence and balloon catheter compliance will also be monitored. Long-term reproductive outcomes will be evaluated over three years. The study aims to measure the rate of adhesion formation as the primary outcome and includes safety and patient compliance as secondary outcomes.

Intrauterine Stent Placement Following Hysteroscopic Septum Resection