Endometrial PolypHYSTOPNCT06526962
5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser for Hysteroscopic Polypectomy
An observational study of Endometrial Polyp, run by University of Cagliari at 1 site in Italy.
Trial summary
The primary objective of this study is to compare the performance of two different surgical instruments, the 5 Fr bipolar electrode and the 5 Fr angled conical optical fiber for dual wavelength diode laser, in performing hysteroscopic polypectomy in an outpatient setting. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Endometrial Polyp
- What is being tested?
- 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser
- Type of treatment
- Medical device
- How many people
- 214 participants
- Where
- 1 siteItaly
- Study dates
- 7 May 2024to 7 May 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with an indication for diagnostic and/or operative outpatient hysteroscopic polypectomy
Who may be able to join
- age ≥18 years and < 60 years;
- suspicion of a single endometrial polyp, documented by ultrasound, with dimensions less than 20 mm;
- presence of abnormal uterine bleeding or history of infertility (defined as absence of conception after 12 months of regular unprotected intercourse aimed at conception);
- consent to participate in the study.
Who cannot join
- presence of multiple endometrial polyps;
- presence of a single endometrial polyp with dimensions greater than 20 mm;
- concurrent presence of intrauterine fibroids, focal or diffuse endometrial thickening, and/or intrauterine adhesions (synechiae);
- current or recent use (< 3 months) of anticoagulant drugs and/or Selective Estrogen Receptor Modulators (SERMs);
- presence of another known cause of vaginal/cervical bleeding;
- suspected adnexal pathology;
Show all 10Show fewer
- confirmed diagnosis of endometrial cancer;
- suspected acute pelvic inflammation or recent history of pelvic inflammation (< 6 months);
- presence of tight cervical canal stenosis;
- requirement for any type of anesthesia to perform the hysteroscopic procedure.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Cagliari
Cagliari, 09042
Salvatore Giovanni Vitale, PhD, 3479354575, salvatoreg.vitale@unica.it
Stefano Angioni, phd
About this study
Official title: Comparison Between Two Different Tools for Outpatient Hysteroscopic Polypectomy: 5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser
The primary objective of this study is to compare the performance of two different surgical instruments, the 5 Fr bipolar electrode and the 5 Fr angled conical optical fiber for dual wavelength diode laser, in performing hysteroscopic polypectomy in an outpatient setting.
Read the detailed description
More specifically, the study aims to compare these instruments by evaluating the following parameters:
- Duration of the procedure;
- Use of any additional accessory instrumentation;
- Effectiveness of the procedure;
- Safety of the procedure;
- Adequacy of the operative specimen for histological analysis;
- Overall suitability of the instrument used;
- Levels of pain and anxiety perceived by the patient during the procedure;
- Changes in the patient's quality of life related to the persistence or resolution of symptoms following the procedure.
A prospective observational study will be conducted at the Obstetrics and Gynecology Clinic of the University Hospital "Duilio Casula" in Monserrato (Italy), following the approval of the study design by the Ethics Committee. Women who meet the inclusion and exclusion criteria will undergo a thorough medical history and gynecological clinical evaluation before performing diagnostic and operative hysteroscopy (T0). The characteristics of the participants, including age, ethnicity, weight, height, lifestyle habits, and medication use, will be recorded in a dedicated database. Each patient will be assigned an ID, which will serve as the patient's unique identifier.
Before performing the hysteroscopic procedure, each patient recruited for the study (T0) will undergo a thorough pelvic ultrasound evaluation using a transvaginal probe by an experienced sonographer (at least 500 procedures performed) according to standard protocols to evaluate the ultrasonographic characteristics of the endometrial polyp. Specifically, the location, size, echostructure, and vascular pattern will be carefully assessed and recorded. During the recruitment phase (T0), the EuroQol-5D questionnaire will be administered to determine the impact of symptoms related to the presence of the lesion on the patient's perceived quality of life. The Italian version of the EuroQol-5D questionnaire, validated by the EuroQoL Group, will be used for this study.
All recruited patients will then undergo diagnostic and operative hysteroscopy (T1) in an outpatient setting without any anesthesia/sedation or pharmacological/mechanical cervical preparation, using a 5 mm continuous flow Bettocchi rigid hysteroscope with a 5 Fr (1.67 mm) working channel and 30° optics (Karl Storz SE \& Co. KG, Tuttlingen, Germany), performed by the same experienced operator (at least 500 procedures performed). The procedures will be carried out using a vaginoscopic approach. Uterine cavity distension will be achieved using saline solution, delivered by an electronic irrigation/aspiration pump (Endomat, Karl Storz SE \& Co. KG, Tuttlingen, Germany), maintaining an intracavitary pressure ≤ 50 mmHg and an intrauterine flow ≤ 300 mL/min. Illumination will be provided by a 300 W Xenon light source. Images will be displayed on a high-resolution color monitor using an integrated circuit camera, and all procedures will be video recorded from the introduction of the hysteroscope until its extraction.
In this study phase, endocavitary characterization of endometrial polyps will be performed based on their size, location, and relationship to the tubal ostia, as well as their consistency and implantation base characteristics. Patients will then undergo polypectomy using one of two possible instruments: a 5 Fr "twizzle" bipolar electrode or a 5 Fr angled conical optical fiber for a dual-wavelength diode laser. The choice of instrument for each operative procedure will be at the operator's discretion.
During the procedure, the operator will be assisted by two assistants: one will manage the instrumentation, and the other will record the time required for the procedure and any use of additional accessory instrumentation, following the operator's instructions. Additionally, the latter will document on a dedicated form any events or symptoms experienced by the patient during the procedure and the 30-minute post-procedure observation period. The performance of each instrument will be subjectively evaluated by the operator regarding its cutting and coagulation precision, using a numerical rating scale from 0 to 10, where 0 indicates the minimum value and 10 the maximum value (Numerical Rating Scale, NRS). Furthermore, the adequacy of the removed sample for histological investigation will be assessed by the pathologist using a similar numerical rating scale (0 to 10, where 0 indicates the minimum appropriateness and 10 the maximum). Elements that may characterize the sample's adequacy include sufficient tissue quantity, absence of crushing, tearing, or electrocution artifacts, and adequate fixation.
Twenty minutes after completing the hysteroscopy (T2), the patient's perception of pain and anxiety levels experienced during the procedure will be assessed. The intensity of perceived pain will be evaluated using the VAS Scale (with levels ranging from 0 to 10, where 0 refers to no pain, 1-3 mild pain, 4-7 moderate pain, 8-10 severe pain) and the McGill Pain Questionnaire (which investigates perceived pain levels across three dimensions: sensory, affective, and evaluative). Anxiety levels experienced during the procedure will be assessed using the Hospital Anxiety and Depression Scale (H.A.D.S.). If the postoperative course is regular, patients will be discharged 30 minutes after the hysteroscopy.
Each patient will then undergo a post-surgical follow-up (T3) 60 days after the procedure, during which a thorough pelvic ultrasound evaluation will be performed (using the same previously described methods) primarily to investigate the possible presence of residual formations. The EuroQol-5D questionnaire will be administered again, and any late surgical complications will be recorded on a dedicated evaluation form.
- Conditions
- Endometrial Polyp
- Being tested
- 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser
- Keywords
- Hysteroscopy, Outpatient, Endometrial Polyp, Polypectomy, Dual Wave-Lenght Diode Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laserDevice
Outpatient hysteroscopic polypectomy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients who undergo outpatient hysteroscopic polypectomy using 5Fr bipolar electrode Receives: Device: 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser | |
| Group B | Patients who undergo outpatient hysteroscopic polypectomy using a conical optical 5Fr fibers for dual wave-length diode laser Receives: Device: 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required to perform the operative hysteroscopic procedure.
The time required to perform the operative hysteroscopic procedure, which will be measured in seconds from the entry into the uterine cavity until the completion of the procedure, defined as the complete resection of the lesion (excluding the time related to the extraction of the resected material).
Measured: End of procedure
Secondary outcomes (8)
Need for supplementary instrumentation
The need for supplementary instrumentation to complete the procedure (e.g., 5 Fr cold blade scissors)
Measured: End of procedure
Effectiveness in removing the lesions
Effectiveness of the procedure (absence/persistence of the lesion), documented by postoperative ultrasound evaluation performed 60 days after the procedure
Measured: 60 days
Adverse events
Adverse events related to the procedure (e.g., vagal syndromes, bleeding, uterine perforations, or other injuries to the uterus and adjacent organs)
Measured: 30 minutes
Quantity of resected tissue
Adequacy of the resected material weight for histological examination (weight in grams)
Measured: 40 days
Instrument Suitability
Overall suitability of the instrument used (in terms of its cutting and coagulation precision), as judged by the operating surgeon
Measured: End of procedure
Pain perception
The level of pain perceived by the patient during the procedure, evaluated using the Visual Analog Scale (VAS, from a minimum value of 1 to a maximum value of 10, where 1 is the best outcome and 10 is the worst outcome)
Measured: 20 minutes
Level of anxiety during the procedure
Level of anxiety experienced by the patient during the procedure, evaluated using the Hospital Anxiety and Depression Scale (H.A.D.S.), from a minimum value of 0 to a maximum value of 21, where 0 is the best outcome and 21 is the worst outcome)
Measured: 20 minutes
Patients' quality of life
Changes in the patient's perceived quality of life 60 days after the procedure, evaluated using the EuroQol-5D questionnaire (EuroQol 5-dimension questionnaire, from a minimum value of 0 to a maximum value of 100, where 0 is the worst outcome and 100 is the best outcome).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start7 May 2024
- Primary completion7 Nov 2024 (estimated)
- Study completion7 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Endometrial PolypStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 214 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Giovanni Vitale, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526962
- Sponsor's protocol ID
- HYSTOP
- Acronym
- HYSTOP
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Salazar CA, Isaacson KB. Office Operative Hysteroscopy: An Update. J Minim Invasive Gynecol. 2018 Feb;25(2):199-208. doi: 10.1016/j.jmig.2017.08.009. Epub 2017 Aug 10.
PubMed 28803811Luerti M, Vitagliano A, Di Spiezio Sardo A, Angioni S, Garuti G, De Angelis C; Italian School of Minimally Invasive Gynecological Surgery Hysteroscopists Group. Effectiveness of Hysteroscopic Techniques for Endometrial Polyp Removal: The Italian Multicenter Trial. J Minim Invasive Gynecol. 2019 Sep-Oct;26(6):1169-1176. doi: 10.1016/j.jmig.2018.12.002. Epub 2018 Dec 7.
PubMed 30528831Vitale SG, Sapia F, Rapisarda AMC, Valenti G, Santangelo F, Rossetti D, Chiofalo B, Sarpietro G, La Rosa VL, Triolo O, Noventa M, Gizzo S, Lagana AS. Hysteroscopic Morcellation of Submucous Myomas: A Systematic Review. Biomed Res Int. 2017;2017:6848250. doi: 10.1155/2017/6848250. Epub 2017 Aug 29.
PubMed 28948169Bougie O, Lortie K, Shenassa H, Chen I, Singh SS. Treatment of Asherman's syndrome in an outpatient hysteroscopy setting. J Minim Invasive Gynecol. 2015 Mar-Apr;22(3):446-50. doi: 10.1016/j.jmig.2014.12.006. Epub 2014 Dec 10.
PubMed 25497164Bar-On S, Ben-David A, Rattan G, Grisaru D. Is outpatient hysteroscopy accurate for the diagnosis of endometrial pathology among perimenopausal and postmenopausal women? Menopause. 2018 Feb;25(2):160-164. doi: 10.1097/GME.0000000000000961.
PubMed 28763396Piecak K, Milart P. Hysteroscopic myomectomy. Prz Menopauzalny. 2017 Dec;16(4):126-128. doi: 10.5114/pm.2017.72757. Epub 2017 Dec 30.
PubMed 29483854Lasmar RB, Barrozo PR, Dias R, Oliveira MA. Submucous myomas: a new presurgical classification to evaluate the viability of hysteroscopic surgical treatment--preliminary report. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):308-11. doi: 10.1016/j.jmig.2005.05.014.
PubMed 16036188Lasmar RB, Xinmei Z, Indman PD, Celeste RK, Di Spiezio Sardo A. Feasibility of a new system of classification of submucous myomas: a multicenter study. Fertil Steril. 2011 May;95(6):2073-7. doi: 10.1016/j.fertnstert.2011.01.147. Epub 2011 Feb 21.
PubMed 21333985Lara-Dominguez MD, Arjona-Berral JE, Dios-Palomares R, Castelo-Branco C. Outpatient hysteroscopic polypectomy: bipolar energy system (Versapoint(R)) versus diode laser - randomized clinical trial. Gynecol Endocrinol. 2016;32(3):196-200. doi: 10.3109/09513590.2015.1105209. Epub 2015 Nov 3.
PubMed 26527251von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008.
PubMed 18313558Van Den Bosch T, Verbakel JY, Valentin L, Wynants L, De Cock B, Pascual MA, Leone FPG, Sladkevicius P, Alcazar JL, Votino A, Fruscio R, Lanzani C, Van Holsbeke C, Rossi A, Jokubkiene L, Kudla M, Jakab A, Domali E, Epstein E, Van Pachterbeke C, Bourne T, Van Calster B, Timmerman D. Typical ultrasound features of various endometrial pathologies described using International Endometrial Tumor Analysis (IETA) terminology in women with abnormal uterine bleeding. Ultrasound Obstet Gynecol. 2021 Jan;57(1):164-172. doi: 10.1002/uog.22109.
PubMed 32484286Herdman M, Badia X, Berra S. [EuroQol-5D: a simple alternative for measuring health-related quality of life in primary care]. Aten Primaria. 2001 Oct 15;28(6):425-30. doi: 10.1016/s0212-6567(01)70406-4. No abstract available. Spanish.
PubMed 11602124Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.
PubMed 28850536Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
PubMed 22588767
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Different Tools for Outpatient Hysteroscopic Polypectomy: 5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser
- ClinicalTrials.gov ID
- NCT06526962
- Acronym / sponsor ID
- HYSTOP / HYSTOP
- Conditions
- Endometrial Polyp
- Keywords
- Hysteroscopy, Outpatient, Endometrial Polyp, Polypectomy, Dual Wave-Lenght Diode Laser
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 7 Nov 2024 (estimated)
- Study completion
- 7 May 2025 (estimated)
- First posted
- 30 Jul 2024 (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.
The primary objective of this study is to compare the performance of two different surgical instruments, the 5 Fr bipolar electrode and the 5 Fr angled conical optical fiber for dual wavelength diode laser, in performing hysteroscopic polypectomy in an outpatient setting.
Detailed description
More specifically, the study aims to compare these instruments by evaluating the following parameters:
- Duration of the procedure;
- Use of any additional accessory instrumentation;
- Effectiveness of the procedure;
- Safety of the procedure;
- Adequacy of the operative specimen for histological analysis;
- Overall suitability of the instrument used;
- Levels of pain and anxiety perceived by the patient during the procedure;
- Changes in the patient's quality of life related to the persistence or resolution of symptoms following the procedure.
A prospective observational study will be conducted at the Obstetrics and Gynecology Clinic of the University Hospital "Duilio Casula" in Monserrato (Italy), following the approval of the study design by the Ethics Committee. Women who meet the inclusion and exclusion criteria will undergo a thorough medical history and gynecological clinical evaluation before performing diagnostic and operative hysteroscopy (T0). The characteristics of the participants, including age, ethnicity, weight, height, lifestyle habits, and medication use, will be recorded in a dedicated database. Each patient will be assigned an ID, which will serve as the patient's unique identifier.
Before performing the hysteroscopic procedure, each patient recruited for the study (T0) will undergo a thorough pelvic ultrasound evaluation using a transvaginal probe by an experienced sonographer (at least 500 procedures performed) according to standard protocols to evaluate the ultrasonographic characteristics of the endometrial polyp. Specifically, the location, size, echostructure, and vascular pattern will be carefully assessed and recorded. During the recruitment phase (T0), the EuroQol-5D questionnaire will be administered to determine the impact of symptoms related to the presence of the lesion on the patient's perceived quality of life. The Italian version of the EuroQol-5D questionnaire, validated by the EuroQoL Group, will be used for this study.
All recruited patients will then undergo diagnostic and operative hysteroscopy (T1) in an outpatient setting without any anesthesia/sedation or pharmacological/mechanical cervical preparation, using a 5 mm continuous flow Bettocchi rigid hysteroscope with a 5 Fr (1.67 mm) working channel and 30° optics (Karl Storz SE \& Co. KG, Tuttlingen, Germany), performed by the same experienced operator (at least 500 procedures performed). The procedures will be carried out using a vaginoscopic approach. Uterine cavity distension will be achieved using saline solution, delivered by an electronic irrigation/aspiration pump (Endomat, Karl Storz SE \& Co. KG, Tuttlingen, Germany), maintaining an intracavitary pressure ≤ 50 mmHg and an intrauterine flow ≤ 300 mL/min. Illumination will be provided by a 300 W Xenon light source. Images will be displayed on a high-resolution color monitor using an integrated circuit camera, and all procedures will be video recorded from the introduction of the hysteroscope until its extraction.
In this study phase, endocavitary characterization of endometrial polyps will be performed based on their size, location, and relationship to the tubal ostia, as well as their consistency and implantation base characteristics. Patients will then undergo polypectomy using one of two possible instruments: a 5 Fr "twizzle" bipolar electrode or a 5 Fr angled conical optical fiber for a dual-wavelength diode laser. The choice of instrument for each operative procedure will be at the operator's discretion.
During the procedure, the operator will be assisted by two assistants: one will manage the instrumentation, and the other will record the time required for the procedure and any use of additional accessory instrumentation, following the operator's instructions. Additionally, the latter will document on a dedicated form any events or symptoms experienced by the patient during the procedure and the 30-minute post-procedure observation period. The performance of each instrument will be subjectively evaluated by the operator regarding its cutting and coagulation precision, using a numerical rating scale from 0 to 10, where 0 indicates the minimum value and 10 the maximum value (Numerical Rating Scale, NRS). Furthermore, the adequacy of the removed sample for histological investigation will be assessed by the pathologist using a similar numerical rating scale (0 to 10, where 0 indicates the minimum appropriateness and 10 the maximum). Elements that may characterize the sample's adequacy include sufficient tissue quantity, absence of crushing, tearing, or electrocution artifacts, and adequate fixation.
Twenty minutes after completing the hysteroscopy (T2), the patient's perception of pain and anxiety levels experienced during the procedure will be assessed. The intensity of perceived pain will be evaluated using the VAS Scale (with levels ranging from 0 to 10, where 0 refers to no pain, 1-3 mild pain, 4-7 moderate pain, 8-10 severe pain) and the McGill Pain Questionnaire (which investigates perceived pain levels across three dimensions: sensory, affective, and evaluative). Anxiety levels experienced during the procedure will be assessed using the Hospital Anxiety and Depression Scale (H.A.D.S.). If the postoperative course is regular, patients will be discharged 30 minutes after the hysteroscopy.
Each patient will then undergo a post-surgical follow-up (T3) 60 days after the procedure, during which a thorough pelvic ultrasound evaluation will be performed (using the same previously described methods) primarily to investigate the possible presence of residual formations. The EuroQol-5D questionnaire will be administered again, and any late surgical complications will be recorded on a dedicated evaluation form.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laserPatients who undergo outpatient hysteroscopic polypectomy using 5Fr bipolar electrode |
| Group B | – | Device: 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laserPatients who undergo outpatient hysteroscopic polypectomy using a conical optical 5Fr fibers for dual wave-length diode laser |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with an indication for diagnostic and/or operative outpatient hysteroscopic polypectomy
Key inclusion criteria (4 listed)
- age ≥18 years and < 60 years;
- suspicion of a single endometrial polyp, documented by ultrasound, with dimensions less than 20 mm;
- presence of abnormal uterine bleeding or history of infertility (defined as absence of conception after 12 months of regular unprotected intercourse aimed at conception);
- consent to participate in the study.
Key exclusion criteria (10 listed)
- presence of multiple endometrial polyps;
- presence of a single endometrial polyp with dimensions greater than 20 mm;
- concurrent presence of intrauterine fibroids, focal or diffuse endometrial thickening, and/or intrauterine adhesions (synechiae);
- current or recent use (< 3 months) of anticoagulant drugs and/or Selective Estrogen Receptor Modulators (SERMs);
- presence of another known cause of vaginal/cervical bleeding;
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 |
|---|---|---|
| 5Fr hysteroscopic bipolar electrode or conical optical 5Fr fibers for dual wave-length diode laserOutpatient hysteroscopic polypectomy | Device | Group A, Group B |
Primary outcome
Time required to perform the operative hysteroscopic procedure.
Time frame: End of procedure
The time required to perform the operative hysteroscopic procedure, which will be measured in seconds from the entry into the uterine cavity until the completion of the procedure, defined as the complete resection of the lesion (excluding the time related to the extraction of the resected material).
8 secondary outcomes
Need for supplementary instrumentation
Time frame: End of procedure
Effectiveness in removing the lesions
Time frame: 60 days
Adverse events
Time frame: 30 minutes
Quantity of resected tissue
Time frame: 40 days
Instrument Suitability
Time frame: End of procedure
Pain perception
Time frame: 20 minutes
Level of anxiety during the procedure
Time frame: 20 minutes
Patients' quality of life
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 28803811Salazar CA, Isaacson KB. Office Operative Hysteroscopy: An Update. J Minim Invasive Gynecol. 2018 Feb;25(2):199-208. doi: 10.1016/j.jmig.2017.08.009. Epub 2017 Aug 10.
- Background: PubMed 30528831Luerti M, Vitagliano A, Di Spiezio Sardo A, Angioni S, Garuti G, De Angelis C; Italian School of Minimally Invasive Gynecological Surgery Hysteroscopists Group. Effectiveness of Hysteroscopic Techniques for Endometrial Polyp Removal: The Italian Multicenter Trial. J Minim Invasive Gynecol. 2019 Sep-Oct;26(6):1169-1176. doi: 10.1016/j.jmig.2018.12.002. Epub 2018 Dec 7.
- Background: PubMed 28948169Vitale SG, Sapia F, Rapisarda AMC, Valenti G, Santangelo F, Rossetti D, Chiofalo B, Sarpietro G, La Rosa VL, Triolo O, Noventa M, Gizzo S, Lagana AS. Hysteroscopic Morcellation of Submucous Myomas: A Systematic Review. Biomed Res Int. 2017;2017:6848250. doi: 10.1155/2017/6848250. Epub 2017 Aug 29.
- Background: PubMed 25497164Bougie O, Lortie K, Shenassa H, Chen I, Singh SS. Treatment of Asherman's syndrome in an outpatient hysteroscopy setting. J Minim Invasive Gynecol. 2015 Mar-Apr;22(3):446-50. doi: 10.1016/j.jmig.2014.12.006. Epub 2014 Dec 10.
- Background: PubMed 28763396Bar-On S, Ben-David A, Rattan G, Grisaru D. Is outpatient hysteroscopy accurate for the diagnosis of endometrial pathology among perimenopausal and postmenopausal women? Menopause. 2018 Feb;25(2):160-164. doi: 10.1097/GME.0000000000000961.
- Background: PubMed 29483854Piecak K, Milart P. Hysteroscopic myomectomy. Prz Menopauzalny. 2017 Dec;16(4):126-128. doi: 10.5114/pm.2017.72757. Epub 2017 Dec 30.
- Background: PubMed 16036188Lasmar RB, Barrozo PR, Dias R, Oliveira MA. Submucous myomas: a new presurgical classification to evaluate the viability of hysteroscopic surgical treatment--preliminary report. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):308-11. doi: 10.1016/j.jmig.2005.05.014.
- Background: PubMed 21333985Lasmar RB, Xinmei Z, Indman PD, Celeste RK, Di Spiezio Sardo A. Feasibility of a new system of classification of submucous myomas: a multicenter study. Fertil Steril. 2011 May;95(6):2073-7. doi: 10.1016/j.fertnstert.2011.01.147. Epub 2011 Feb 21.
- Background: PubMed 26527251Lara-Dominguez MD, Arjona-Berral JE, Dios-Palomares R, Castelo-Branco C. Outpatient hysteroscopic polypectomy: bipolar energy system (Versapoint(R)) versus diode laser - randomized clinical trial. Gynecol Endocrinol. 2016;32(3):196-200. doi: 10.3109/09513590.2015.1105209. Epub 2015 Nov 3.
- Background: PubMed 18313558von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008.
- Background: PubMed 32484286Van Den Bosch T, Verbakel JY, Valentin L, Wynants L, De Cock B, Pascual MA, Leone FPG, Sladkevicius P, Alcazar JL, Votino A, Fruscio R, Lanzani C, Van Holsbeke C, Rossi A, Jokubkiene L, Kudla M, Jakab A, Domali E, Epstein E, Van Pachterbeke C, Bourne T, Van Calster B, Timmerman D. Typical ultrasound features of various endometrial pathologies described using International Endometrial Tumor Analysis (IETA) terminology in women with abnormal uterine bleeding. Ultrasound Obstet Gynecol. 2021 Jan;57(1):164-172. doi: 10.1002/uog.22109.
- Background: PubMed 11602124Herdman M, Badia X, Berra S. [EuroQol-5D: a simple alternative for measuring health-related quality of life in primary care]. Aten Primaria. 2001 Oct 15;28(6):425-30. doi: 10.1016/s0212-6567(01)70406-4. No abstract available. Spanish.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Polyp, run by University of Cagliari at 1 site in Italy.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Giovanni Vitale, PhD (3479354575, salvatoreg.vitale@unica.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required to perform the operative hysteroscopic procedure. (time frame: End of procedure). 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 NCT06526962, which also lists 15 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 30 Jul 2024.