Myoma;UterusNCT07280286
Incidence of Intrauterine Adhesions After Myomectomy With Intrauterine Anti-Adhesion Gel
A study testing Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure in people with Myoma;Uterus and Adhesion; Uterus, Internal, run by Federico II University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Myoma;Uterus, Adhesion; Uterus, Internal
- What is being tested?
- Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2025to 20 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Incidence of Intrauterine Adhesions Following Myomectomies With the Use of an Intrauterine Anti-adhesion Gel
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.
Read the detailed description
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.
- Conditions
- Myoma;Uterus, Adhesion; Uterus, Internal
- Being tested
- Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure
- Keywords
- intrauterine adhesions, myomectomy
- Medical subject headings
- Myofibroma, Tissue Adhesions, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Anti-adhesion gel group | Experimental | Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure. Receives: Device: Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure |
| Standard of care group | No intervention | Women will not receive any anti-adhesion methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to two months after surgery
Secondary outcomes (5)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start9 Dec 2025 (estimated)
- Primary completion6 Apr 2026 (estimated)
- Study completion20 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Myoma;UterusStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted as a prospective, randomized, non-profit trial
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brunella Zizolfi, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280286
- Sponsor's protocol ID
- KE5DXJL9Z1F5
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mercorio A, Della Corte L, Boccia D, Palumbo M, Reppuccia S, Buonfantino C, Cuomo L, Borgo M, Zitiello A, De Angelis MC, Lagana AS, Bifulco G, Giampaolino P. Myomectomy in infertile women: More harm than good? Front Surg. 2023 Apr 17;10:1151901. doi: 10.3389/fsurg.2023.1151901. eCollection 2023.
PubMed 37139194Bortoletto P, Keefe KW, Unger E, Hariton E, Gargiulo AR. Incidence and risk factors of intrauterine adhesions after myomectomy. F S Rep. 2022 May 28;3(3):269-274. doi: 10.1016/j.xfre.2022.05.007. eCollection 2022 Sep.
PubMed 36212555Asgari Z, Hafizi L, Hosseini R, Javaheri A, Rastad H. Intrauterine synechiae after myomectomy; laparotomy versus laparoscopy: Non-randomized interventional trial. Iran J Reprod Med. 2015 Mar;13(3):161-8.
PubMed 26000007Lagana AS, Garzon S, Dababou S, Uccella S, Medvediev M, Pokrovenko D, Babunashvili EL, Buyanova SN, Schukina NA, Shcherbatykh Kaschchuk MG, Kosmas I, Licchelli M, Panese G, Tinelli A. Prevalence of Intrauterine Adhesions after Myomectomy: A Prospective Multicenter Observational Study. Gynecol Obstet Invest. 2022;87(1):62-69. doi: 10.1159/000522583. Epub 2022 Feb 15.
PubMed 35168241Capmas P, Pourcelot AG, Fernandez H. Are synechiae a complication of laparotomic myomectomy? Reprod Biomed Online. 2018 Apr;36(4):450-454. doi: 10.1016/j.rbmo.2018.01.010. Epub 2018 Feb 2.
PubMed 29454580Pellicano M, Guida M, Bramante S, Acunzo G, Di Spiezio Sardo A, Tommaselli GA, Nappi C. Reproductive outcome after autocrosslinked hyaluronic acid gel application in infertile patients who underwent laparoscopic myomectomy. Fertil Steril. 2005 Feb;83(2):498-500. doi: 10.1016/j.fertnstert.2004.09.019.
PubMed 15705404Acunzo G, Guida M, Pellicano M, Tommaselli GA, Di Spiezio Sardo A, Bifulco G, Cirillo D, Taylor A, Nappi C. Effectiveness of auto-cross-linked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic adhesiolysis: a prospective, randomized, controlled study. Hum Reprod. 2003 Sep;18(9):1918-21. doi: 10.1093/humrep/deg368.
PubMed 12923149Guida M, Acunzo G, Di Spiezio Sardo A, Bifulco G, Piccoli R, Pellicano M, Cerrota G, Cirillo D, Nappi C. Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Hum Reprod. 2004 Jun;19(6):1461-4. doi: 10.1093/humrep/deh238. Epub 2004 Apr 22.
PubMed 15105384Pellicano M, Bramante S, Cirillo D, Palomba S, Bifulco G, Zullo F, Nappi C. Effectiveness of autocrosslinked hyaluronic acid gel after laparoscopic myomectomy in infertile patients: a prospective, randomized, controlled study. Fertil Steril. 2003 Aug;80(2):441-4. doi: 10.1016/s0015-0282(03)00597-1.
PubMed 12909511Sheng Y, Hong Z, Wang J, Mao B, Wu Z, Gou Y, Zhao J, Liu Q. Efficacy and safety of robot-assisted laparoscopic myomectomy versus laparoscopic myomectomy: a systematic evaluation and meta-analysis. World J Surg Oncol. 2023 Jul 28;21(1):230. doi: 10.1186/s12957-023-03104-8.
PubMed 37507735Di Saverio S, Coccolini F, Galati M, Smerieri N, Biffl WL, Ansaloni L, Tugnoli G, Velmahos GC, Sartelli M, Bendinelli C, Fraga GP, Kelly MD, Moore FA, Mandala V, Mandala S, Masetti M, Jovine E, Pinna AD, Peitzman AB, Leppaniemi A, Sugarbaker PH, Goor HV, Moore EE, Jeekel J, Catena F. Bologna guidelines for diagnosis and management of adhesive small bowel obstruction (ASBO): 2013 update of the evidence-based guidelines from the world society of emergency surgery ASBO working group. World J Emerg Surg. 2013 Oct 10;8(1):42. doi: 10.1186/1749-7922-8-42.
PubMed 24112637Moris D, Chakedis J, Rahnemai-Azar AA, Wilson A, Hennessy MM, Athanasiou A, Beal EW, Argyrou C, Felekouras E, Pawlik TM. Postoperative Abdominal Adhesions: Clinical Significance and Advances in Prevention and Management. J Gastrointest Surg. 2017 Oct;21(10):1713-1722. doi: 10.1007/s11605-017-3488-9. Epub 2017 Jul 6.
PubMed 28685387Beyene RT, Kavalukas SL, Barbul A. Intra-abdominal adhesions: Anatomy, physiology, pathophysiology, and treatment. Curr Probl Surg. 2015 Jul;52(7):271-319. doi: 10.1067/j.cpsurg.2015.05.001. Epub 2015 Jun 9. No abstract available.
PubMed 26258583Okabayashi K, Ashrafian H, Zacharakis E, Hasegawa H, Kitagawa Y, Athanasiou T, Darzi A. Adhesions after abdominal surgery: a systematic review of the incidence, distribution and severity. Surg Today. 2014 Mar;44(3):405-20. doi: 10.1007/s00595-013-0591-8. Epub 2013 May 9.
PubMed 23657643Tabibian N, Swehli E, Boyd A, Umbreen A, Tabibian JH. Abdominal adhesions: A practical review of an often overlooked entity. Ann Med Surg (Lond). 2017 Jan 31;15:9-13. doi: 10.1016/j.amsu.2017.01.021. eCollection 2017 Mar.
PubMed 28203370
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Intrauterine Adhesions Following Myomectomies With the Use of an Intrauterine Anti-adhesion Gel
- ClinicalTrials.gov ID
- NCT07280286
- Acronym / sponsor ID
- KE5DXJL9Z1F5
- Conditions
- Myoma;Uterus, Adhesion; Uterus, Internal
- Keywords
- intrauterine adhesions, myomectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 9 Dec 2025 (estimated)
- Primary completion
- 6 Apr 2026 (estimated)
- Study completion
- 20 Nov 2028 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be conducted as a prospective, randomized, non-profit trial
| Arm | Type | Receives |
|---|---|---|
| Anti-adhesion gel group | Experimental | Device: Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedureWomen will receive the application of an anti-adhesion gel at the end of the myomectomy procedure. |
| Standard of care group | No intervention | –Women will not receive any anti-adhesion methods |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedureThe 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. | Device | Anti-adhesion gel group |
Primary outcome
Efficacy of intrauterine gel in reducing the formation of intrauterine adhesions
Time frame: Up to two months after surgery
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.
5 secondary outcomes
Clinical Pregnancy Rate
Time frame: Up to 24 months after surgery
Live Birth Rate (LBR)
Time frame: Up to 24 months post-surgery.
Miscarriage Rate
Time frame: Up to 24 months after surgery
Pregnancy Complications
Time frame: Up to 24 months after surgery
Mode of delivery
Time frame: Up to 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Background: PubMed 37139194Mercorio A, Della Corte L, Boccia D, Palumbo M, Reppuccia S, Buonfantino C, Cuomo L, Borgo M, Zitiello A, De Angelis MC, Lagana AS, Bifulco G, Giampaolino P. Myomectomy in infertile women: More harm than good? Front Surg. 2023 Apr 17;10:1151901. doi: 10.3389/fsurg.2023.1151901. eCollection 2023.
- Background: PubMed 36212555Bortoletto P, Keefe KW, Unger E, Hariton E, Gargiulo AR. Incidence and risk factors of intrauterine adhesions after myomectomy. F S Rep. 2022 May 28;3(3):269-274. doi: 10.1016/j.xfre.2022.05.007. eCollection 2022 Sep.
- Background: PubMed 26000007Asgari Z, Hafizi L, Hosseini R, Javaheri A, Rastad H. Intrauterine synechiae after myomectomy; laparotomy versus laparoscopy: Non-randomized interventional trial. Iran J Reprod Med. 2015 Mar;13(3):161-8.
- Background: PubMed 35168241Lagana AS, Garzon S, Dababou S, Uccella S, Medvediev M, Pokrovenko D, Babunashvili EL, Buyanova SN, Schukina NA, Shcherbatykh Kaschchuk MG, Kosmas I, Licchelli M, Panese G, Tinelli A. Prevalence of Intrauterine Adhesions after Myomectomy: A Prospective Multicenter Observational Study. Gynecol Obstet Invest. 2022;87(1):62-69. doi: 10.1159/000522583. Epub 2022 Feb 15.
- Background: PubMed 29454580Capmas P, Pourcelot AG, Fernandez H. Are synechiae a complication of laparotomic myomectomy? Reprod Biomed Online. 2018 Apr;36(4):450-454. doi: 10.1016/j.rbmo.2018.01.010. Epub 2018 Feb 2.
- Background: PubMed 15705404Pellicano M, Guida M, Bramante S, Acunzo G, Di Spiezio Sardo A, Tommaselli GA, Nappi C. Reproductive outcome after autocrosslinked hyaluronic acid gel application in infertile patients who underwent laparoscopic myomectomy. Fertil Steril. 2005 Feb;83(2):498-500. doi: 10.1016/j.fertnstert.2004.09.019.
- Background: PubMed 12923149Acunzo G, Guida M, Pellicano M, Tommaselli GA, Di Spiezio Sardo A, Bifulco G, Cirillo D, Taylor A, Nappi C. Effectiveness of auto-cross-linked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic adhesiolysis: a prospective, randomized, controlled study. Hum Reprod. 2003 Sep;18(9):1918-21. doi: 10.1093/humrep/deg368.
- Background: PubMed 15105384Guida M, Acunzo G, Di Spiezio Sardo A, Bifulco G, Piccoli R, Pellicano M, Cerrota G, Cirillo D, Nappi C. Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Hum Reprod. 2004 Jun;19(6):1461-4. doi: 10.1093/humrep/deh238. Epub 2004 Apr 22.
- Background: PubMed 12909511Pellicano M, Bramante S, Cirillo D, Palomba S, Bifulco G, Zullo F, Nappi C. Effectiveness of autocrosslinked hyaluronic acid gel after laparoscopic myomectomy in infertile patients: a prospective, randomized, controlled study. Fertil Steril. 2003 Aug;80(2):441-4. doi: 10.1016/s0015-0282(03)00597-1.
- Background: PubMed 37507735Sheng Y, Hong Z, Wang J, Mao B, Wu Z, Gou Y, Zhao J, Liu Q. Efficacy and safety of robot-assisted laparoscopic myomectomy versus laparoscopic myomectomy: a systematic evaluation and meta-analysis. World J Surg Oncol. 2023 Jul 28;21(1):230. doi: 10.1186/s12957-023-03104-8.
- Background: PubMed 24112637Di Saverio S, Coccolini F, Galati M, Smerieri N, Biffl WL, Ansaloni L, Tugnoli G, Velmahos GC, Sartelli M, Bendinelli C, Fraga GP, Kelly MD, Moore FA, Mandala V, Mandala S, Masetti M, Jovine E, Pinna AD, Peitzman AB, Leppaniemi A, Sugarbaker PH, Goor HV, Moore EE, Jeekel J, Catena F. Bologna guidelines for diagnosis and management of adhesive small bowel obstruction (ASBO): 2013 update of the evidence-based guidelines from the world society of emergency surgery ASBO working group. World J Emerg Surg. 2013 Oct 10;8(1):42. doi: 10.1186/1749-7922-8-42.
- Background: PubMed 28685387Moris D, Chakedis J, Rahnemai-Azar AA, Wilson A, Hennessy MM, Athanasiou A, Beal EW, Argyrou C, Felekouras E, Pawlik TM. Postoperative Abdominal Adhesions: Clinical Significance and Advances in Prevention and Management. J Gastrointest Surg. 2017 Oct;21(10):1713-1722. doi: 10.1007/s11605-017-3488-9. Epub 2017 Jul 6.
- Individual participant dataSharing planned: No
Related trials for Myoma;Uterus
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure in people with Myoma;Uterus and Adhesion; Uterus, Internal, run by Federico II University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brunella Zizolfi, Dr. (+39 3381651272 ext. +39, brunellazizolfi@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of intrauterine gel in reducing the formation of intrauterine adhesions (time frame: Up to two months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07280286, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.