Incidence of Intrauterine Adhesions After Myomectomy With Intrauterine Anti-Adhesion Gel

Intrauterine adhesions (IUAs), or uterine synechiae, are fibrotic bands that develop when the endometrium is damaged and the normal healing process is disrupted. Surgical trauma-particularly involving the basal layer of the endometrium-is one of the main triggers for adhesion formation. Myomectomy is recognized as the gynecologic procedure most frequently associated with the development of adhesions, which may compromise uterine function, menstrual regularity, fertility, and obstetric outcomes. Although minimally invasive approaches such as conventional or robot-assisted laparoscopy have reduced postoperative morbidity, they cannot eliminate the risk of adhesion formation, especially when the uterine cavity is entered or extensive suturing is required.

Adhesion formation results from excessive fibrin deposition and insufficient fibrinolytic activity during tissue repair. When fibrin persists on the injured surfaces, fibroblast proliferation and neovascularization may lead to permanent fibrotic bridges between areas that should remain separated. This process is particularly relevant following myomectomy, where the endometrium may be inadvertently injured. Several studies have reported high rates of intrauterine adhesions after open myomectomy and, to a lesser extent, after minimally invasive procedures. Adhesions may occur even when the cavity is not breached, suggesting that the myometrial trauma itself can contribute to this pathological process.

Anti-adhesion gels have been proposed as an adjunctive strategy to prevent postoperative synechiae. These sterile, absorbable, highly viscous hydrophilic gels-typically composed of sodium carboxymethylcellulose (CMC), polyethylene oxide (PEO), and electrolytes-act as temporary mechanical barriers, physically separating traumatized surfaces during the healing period. Evidence from previous studies suggests that intrauterine gel application after hysteroscopic procedures may reduce adhesion formation and improve postoperative reproductive outcomes. However, few trials have evaluated the efficacy of these gels after laparoscopic or robotic myomectomy.

This study is a prospective, randomized, controlled, non-profit clinical trial designed to assess whether the application of an intrauterine anti-adhesion gel at the end of robotic-assisted laparoscopic myomectomy reduces the incidence of IUAs compared with no adhesion-prevention method. Sixty-two women undergoing myomectomy will be randomized 1:1 into an intervention group (with gel application) or a control group (without gel). All participants will undergo standardized preoperative assessment, including ultrasound and office hysteroscopy. Postoperative follow-up includes ultrasound at one month to evaluate pelvic adhesions and diagnostic hysteroscopy at two months to assess intrauterine adhesions. Reproductive outcomes will be monitored for up to 24 months through spontaneous or assisted conception attempts.

The primary endpoint is the incidence of intrauterine adhesions at follow-up hysteroscopy. Secondary endpoints include clinical pregnancy rate, implantation rate, miscarriage rate, live birth rate, pregnancy complications, mode of delivery, and neonatal outcomes.

The study aims to clarify whether combining a minimally invasive robotic approach with an intrauterine gel can synergistically reduce adhesion formation and improve fertility outcomes. Results may contribute to optimizing postoperative management in women undergoing myomectomy and refining strategies to preserve reproductive potential.

Inclusion criteria

• Age between 18 and 45 years;
• BMI 18-35;
• One or more fibroids diagnosed via ultrasound;
• First myomectomy or uterine surgery;
• Incomplete reproductive plans and/or infertility;
• Adequate immune, respiratory, liver, cardiac, bone marrow, and kidney function;
• Compliance and psychological ability to follow study procedures;
• Acceptance and signing of informed consent.

Exclusion criteria

• Age under 18 years;
• Age over 46 years;
• Pregnancy or breastfeeding;
• History of intrauterine adhesions;
• Diagnosis or suspicion of malignant gynecological pathologies and/or autoimmune diseases;
• Completed reproductive plans;
• Severe respiratory, bone marrow, liver, or kidney dysfunction preventing safe surgical access.