An interventional study of Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure in Myoma;Uterus and Adhesion; Uterus, Internal, sponsored by Federico II University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Federico II University · Not applicable, Interventional, and Prevention
This prospective randomized study aims to evaluate whether the application of an intrauterine anti-adhesion gel reduces the incidence of intrauterine adhesions (IUAs) following robotic-assisted laparoscopic myomectomy. Intrauterine adhesions may develop after endometrial trauma during surgery and can negatively affect menstrual function, fertility, and future pregnancy outcomes. Robotic myomectomy offers a minimally invasive approach, but postoperative adhesion formation remains a concern.
Sixty-two women undergoing myomectomy will be randomized to receive either intrauterine anti-adhesion gel (intervention group) or no adhesion-prevention method (control group). Adhesions will be assessed by ultrasound and hysteroscopy during follow-up. Secondary outcomes include reproductive results over a 24-month period, such as implantation rate, clinical pregnancy, miscarriage, live birth, pregnancy complications, and neonatal outcomes.
The study seeks to determine whether combining a minimally invasive surgical approach with an intrauterine gel provides additional protection against adhesion formation and improves fertility-related outcomes.
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.
121 studies on the registry are indexed under Tissue Adhesions; 15 are open to participants now.
This study's planned enrollment of 62 is close to the median of 61 across 84 interventional studies indexed under Tissue Adhesions.
Browse Tissue Adhesions studies →Federico II University is the lead sponsor of 366 studies on the registry; 61 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure.
Device: Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure
Women will not receive any anti-adhesion methods
The difference compared to other studies published in the past is that, in our trial, at the end of the robotic myomectomy-which will be performed using the same technique in both groups-an anti-adhesion gel will be applied in the intervention group to prevent the formation of intrauterine adhesions.
Efficacy of intrauterine gel in reducing the formation of intrauterine adhesions
The primary objective of the study is to evaluate the efficacy of intrauterine gel in reducing the formation of intrauterine adhesions following robotic-assisted laparoscopic myomectomy. Intrauterine adhesions will be assessed during follow-up ultrasound performed one month after surgery and by diagnostic hysteroscopy two months after surgery. Adhesions will be classified according to an internationally recognized scoring system. The severity, extent, and type of adhesions will be documented using the American Fertility Society (AFS) / American Society for Reproductive Medicine (ASRM) classification system, which categorizes IUAs as mild, moderate, or severe based on the extent of cavity involvement, type of adhesions, and menstrual pattern.
Time frame: Up to two months after surgery
Clinical Pregnancy Rate
Presence of a gestational sac with fetal heartbeat detected on transvaginal ultrasound. Measurement: Confirmed by ultrasound between the 5th and 7th weeks of gestation and recorded in clinical data.
Time frame: Up to 24 months after surgery
Live Birth Rate (LBR)
Percentage of patients delivering a live-born infant after conception. Measurement: Collected from hospital records or via follow-up phone interviews
Time frame: Up to 24 months post-surgery.
Miscarriage Rate
Spontaneous pregnancy loss before 20 weeks of gestation. Measurement: Confirmed by ultrasound or clinical documentation in case of spontaneous abortion.
Time frame: Up to 24 months after surgery
Pregnancy Complications
Adverse events during pregnancy, such as gestational hypertension, preeclampsia, gestational diabetes, or preterm birth. Measurement: Collected from medical charts, obstetric reports, or standardized questionnaires.
Time frame: Up to 24 months after surgery
Mode of delivery
Type of delivery (spontaneous vaginal, assisted vaginal, cesarean section). Measurement: Recorded from birth certificates or hospital delivery records.
Time frame: Up to 24 months after surgery
No study locations are listed for this record.
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Plan to share: No
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