Feasibility of Office-based Operative Hysteroscopy by a Tissue Removal System without Anesthesia.

STUDY OBJECTIVE: To investigate the feasibility of operative hysteroscopy by a hysteroscopic tissue removal system (HTRS) without anesthesia in women with endometrial polyps (EP) or retained products of conception (RPOC). DESIGN: Prospective observational cohort study. SETTING: University-affiliated Department of Obstetrics and Gynecology. PATIENTS: Consenting women aged >18 years diagnosed with EP or RPOC from 9/2022 to 8/2023 confirmed by a prior office hysteroscopy. INTERVENTIONS: Office-based vaginoscopic operative hysteroscopy without anesthesia using the Mini-Elite Truclear HTRS. Oral misoprostol was prescribed for cervical ripening. The patients rated intraoperative and 5-minute postoperative pain levels on a visual analog scale, with mild pain defined as a score of 0 to 4, moderate as 5 to 7, and severe as 8 to 10. A successful procedure was defined as complete removal of the pathology. MEASUREMENTS AND MAIN RESULTS: Fifty patients were included in this pilot study, and 47 (94.0%) procedures were completed successfully, including 21/24 (87.5%) cases of EP and all cases of RPOC (26/26, p = .06). No intra- or postoperative complications occurred. The intraoperative pain levels were rated as mild, moderate, and severe by 26 (52.0%), 16 (32.0%) and 8 (16.0%) patients, respectively. Severe intraoperative pain was more common in nulliparous women and those >10 years from their last vaginal delivery and was not associated with patient age, menopausal status, presence of abnormal uterine bleeding, or pathology size. Severe postoperative pain, reported by 5 (10.0%) patients, was significantly associated with removal of EP compared with RPOC, longer operative time, and nulliparity or >10 years from the last vaginal delivery. The procedure was considered acceptable by 46 (92.0%) patients, and 45 (90.0%) would recommend it to a friend/relative. CONCLUSIONS: Office-based operative hysteroscopy by the HTRS is successful and well tolerated by most women, especially for RPOC removal.

Manual morcellation (Resectr™ 9Fr) vs electromechanical morcellation (TruClear™) for hysteroscopic polypectomy: A randomized controlled non-inferiority trial.

INTRODUCTION: Meta-analyses comparing hysteroscopic electromechanical morcellation with electrosurgical resection showed a shorter operating time for electromechanical morcellation, mainly for polypectomy. The Resectr™ 9Fr is a new hysteroscopic manual morcellator, designed to simplify this procedure. We aimed to compare manual with electromechanical morcellation for hysteroscopic polypectomy. MATERIAL AND METHODS: This two-center randomized controlled non-inferiority trial was performed from 2018 to 2021 in the Catharina Hospital and the Ghent University Hospital. The study was registered at the Dutch Trial Register (NL6922; ICTRP ID: NTR7118). One hundred and forty women with polyps (between 8 and 20 mm) scheduled for hysteroscopic removal were randomized between manual (Resectr™ 9Fr) or electromechanical (TruClear™) morcellation. The primary outcome was time (instrumentation set-up, resection, and total procedure time). RESULTS: The non-inferiority margin for the primary outcome time was 1.3. Mean instrumentation set-up time was 10% shorter with the manual compared with the electromechanical morcellator (estimated mean ratio manual/electromechanical = 0.9; 97.5% confidence interval [CI] 0.8-1.1). Mean resection time was 30% longer with the manual compared with the motor-driven system (estimated mean ratio manual/electromechanical = 1.3; 97.5% CI 0.9-1.9). Mean total procedure time was 10% longer with the manual compared with the electromechanical morcellator (estimated mean ratio manual/electromechanical = 1.1; 95% CI 0.91-1.298). The estimated odds (electromechanical/manual) of better surgeon's safety, effective and comfort scores were, respectively, 4.5 (95% CI 0.9-22.1), 7.0 (95% CI 1.5-31.9), and 5.9 (95% CI 1.1-30.3) times higher with the motor-driven compared with the manual morcellator. Conversion rates and incomplete resection rates were comparable in both groups (manual vs electromechanical) (7.6% [4/66] vs 2.9% [2/68] and 6.1% [4/66] vs 3.0% [2/66], respectively). No intraoperative and postoperative complications were registered. CONCLUSIONS: The manual morcellator was non-inferior to the electromechanical morcellator for hysteroscopic polypectomy in terms of mean instrumentation set-up time and total procedure time. Results on resection time were inconclusive. Conversion and incomplete resection rates were within the range reported in the literature. Surgeon's reported rating for both devices was high, however, in favor of the motor-driven tissue removal system.

Case report: septic shock after endometrial polypectomy with tissue removal system.

As an emerging surgical technology, tissue removal systems have been widely used in the treatment of endometrial polyps due to its characteristics of less endometrial damage, shorter learning curve and clearer vision of the operative field. There are few cases in the literature reporting serious complications after endometrial polypectomy using tissue removal systems. As known, septic shock is a rare complication following hysteroscopic polypectomy. Now, we present the case of a 23-year-old woman who developed septic shock after polypectomy with tissue removal system. The patient had a history of recurrent vaginitis for more than half a year. Due to endometrial polyps, she was admitted to our hospital and scheduled to undergo hysteroscopic endometrial polypectomy. Three hours after the endometrial polypectomy using the tissue removal system, the patient had shock symptoms such as increased body temperature, decreased blood pressure and increased heart rate. Then, the patient was successfully treated and discharged after anti-infection and anti-shock treatments. The purpose of this case report is to remind clinicians to consider the possibility of serious infection and comprehensively evaluate the risk of infection before choosing hysteroscopic devices for endometrial polyps, especially for patients who choose the mechanical hysteroscopic tissue removal systems. Furthermore, the mechanical hysteroscopic tissue removal systems should be used with caution in patients with previous recurrent vaginitis.

Clinical evaluation of a new hand-driven hysteroscopic tissue removal device, Resectr™ 5fr, for the resection of endometrial polyps in an office setting.

PURPOSE: A first clinical evaluation of a new hand-driven hysteroscopic tissue removal device, Resectr™ 5fr, for office polypectomy without any anesthesia. METHODS: Women with at least one small endometrial polyp were eligible. Hysteroscopic polypectomy was performed using the Resectr™ 5fr in an office setting, without any anesthesia. RESULTS: One hundred and two hysteroscopic polypectomies were included in the analysis. The median installation time was 1.9 min (95% confidence interval (CI) 1.6-2.1). The median time to complete polyp removal was 1.2 min (95% CI 0.8-1.6). The median surgeon's safety, practical, and comfort scores on a 5-point Likert scale were high (5 (5-5), 5 (4-5), and 5 (4-5), respectively). Women's pain score was low (median 1 (0-3)), whereas the satisfaction rate was high (median 5 (5-5)), both on a 5-point Likert scale. There were two conversions (hysteroscopic scissors (n = 1), a new Resectr™ 5fr device (n = 1)). There was one incomplete procedure (tissue hardness). CONCLUSION: Hysteroscopic removal of small polyps, using the [Formula: see text] 5fr in an office setting is feasible in terms of installation and resection time. Surgeon's practical, comfort, and safety scores are high, whereas women report low pain scores and high satisfaction rates.  TRIAL REGISTRATION: Dutch Clinical Trial Registry (NTR 7119, NL6923): https://www.trialregister.nl/trial/6923 . Date of registration: 27/03/2018.

Clinical analysis of the MyoSure hysteroscopic tissue removal system of endometrial polyps in women with an intact hymen.

BACKGROUND: To investigate the clinical efficacy of the MyoSure hysteroscopic tissue removal system in the treatment of endometrial and cervical polyps in women with an intact hymen. METHODS: Retrospective analysis was performed on the clinical data of 32 patients treated with the MyoSure hysteroscopic tissue removal system for endometrial and cervical polyps. RESULTS: All the patients successfully completed the procedure. No intraoperative complications, such as cervical trauma, uterine perforation or TURP syndrome, were reported. The surgical time ranged from 5 to 35 min, with an average time of 19.3 min, and the intraoperative blood loss ranged from 2 to 50 ml with an average blood loss of 10.8 ml. After surgery, all patients were shown to have intact hymens. No residual polyp tissues were observed under the microscope, and abnormal uterine bleeding was relieved. CONCLUSIONS: The MyoSure hysteroscopic tissue removal system can be a safe and effective treatment for endometrial and cervical polyps in women with an intact hymen.

Comparison of endometrial polyp recurrence in fertile women after office hysteroscopic endometrial polypectomy using two widely spread techniques.

AIM: To compare the recurrence of benign endometrial polyps after office hysteroscopic polypectomy performed with a bipolar electrode (BE) or a small diameter hysteroscopic tissue removal system (HTRs). METHODS: From July 2018 to December 2019 we evaluated the charts of 114 asymptomatic fertile women who underwent office hysteroscopic polypectomy, 1 year before, for a single large benign endometrial polyp (size between 10 and 20 mm) using a 4 mm continuous flow hysteroscope with a BE or a 5 mm HTRs. Patients, divided into two groups according to surgical procedure, each performed exclusively by one expert gynecologist, were scheduled for a 12-month postoperative transvaginal sonography to evaluate the recurrence of endometrial polyps. RESULTS: Forty-eight women of the BE group and 42 of the HTRs group were considered for the 1-year transvaginal sonography follow-up. Five polyps were identified in the BE group and three in the HTRs group (5/48 vs 3/42, P = n.s.). All polyps were removed hysteroscopically (in three out of five and in two out of three cases, respectively, in the same places of the previous polypectomy) and evaluated as 'benign' by the pathologist. CONCLUSION: Office hysteroscopic endometrial polypectomy with small HTRs compared to BE revealed at a 1-year follow-up no difference in terms of complete removal and recurrence of polyps. HTRs polypectomy resulted in less pain and significantly quicker time of procedure compared to BE. This data should be kept in mind for patient comfort any time hysteroscopic polypectomy is planned in an office setting.

Manually driven versus motor driven hysteroscopic tissue removal system for polypectomy: Long-term results.

OBJECTIVE: The aim of this follow-up study is to compare a manually driven hysteroscopic tissue removal system (ResectrTM 9 Fr) with a motor driven system (TruclearTM) in terms of long-term clinical outcomes such as abnormal uterine bleeding and polyp recurrence. STUDY DESIGN: This is a follow-up of a multicenter randomized controlled trial comparing a manually and motor driven hysteroscopic tissue removal system for polypectomy. This prospective cohort study was performed at Ghent University Hospital (Ghent, Belgium) and Catharina Hospital Eindhoven (Eindhoven, the Netherlands). The trial was registered at Clinicaltrials.gov (Trial ID = NCT05337605, April 2022). Seventy-five women with abnormal uterine bleeding who participated in the randomized controlled trial and had pathological confirmation of the diagnosis of an endometrial polyp, were contacted. Fifty-five women (70.67 %) were willing to participate in this follow-up study. The primary outcome was the recurrence and/or persistence of abnormal uterine bleeding and the time to the recurrence of abnormal uterine bleeding. Secondary outcomes were polyp recurrence and time to polyp recurrence, symptom relief, satisfaction score regarding symptom relief and general satisfaction score regarding the surgical procedure. RESULTS: In the manually driven group, the mean time to the recurrence or persistence of abnormal uterine bleeding was 26 months (95 % CI 20 - 32). In the motor driven group, the mean time to the recurrence or persistence of abnormal uterine bleeding was 29 months (95 % CI 23- 34). A log-rank test showed a non-significant difference between both groups (P =.77). There was no significant difference in polyp recurrence (P =.22) or symptom relief between the two groups (P =.67). Additionally, the groups did not differ in satisfaction scores regarding symptoms or polypectomy (P =.16 and P =.61, respectively). CONCLUSION: This long-term follow-up study showed no statistically significant difference in the recurrence and persistence of abnormal uterine bleeding between a manually and motor driven hysteroscopic tissue removal system for polypectomy.

Comparative analysis of the clinical efficacy and reproductive outcomes of the hysteroscopic tissue removal system (MyoSure) and hysteroscopic electroresection in the treatment of benign intrauterine lesions.

OBJECTIVE: To compare and analyze the clinical efficacy and reproductive outcomes of the hysteroscopic tissue removal system (MyoSure) and hysteroscopic electroresection in the treatment of benign intrauterine lesions in women of reproductive age. METHODS: This is a retrospective study of patients with benign intrauterine lesions treated with MyoSure or hysteroscopic electroresection. The primary outcomes were operative time and resection completeness, and reproductive outcomes were followed up and compared. Secondary outcomes included perioperative adverse events and postoperative adhesions seen during second-look hysteroscopy. Data analysis was performed using χ2 and Fisher tests for qualitative variables and Student t-test for quantitative variables. RESULTS: The operative times of patients with type 0 or I myoma, endometrial polyps, or retained products of conception in the MyoSure group were shorter than those in the electroresection group but were not significantly different for patients with type II myomas. The complete resection rate was lower in the MyoSure group than in the electroresection group. The degree of decrease in the American Fertility Society score of intrauterine adhesion in the MyoSure group was significantly higher (2.90 ± 1.29 points vs 1.31 ± 0.89 points, P = 0.025). The time to pregnancy and the pregnancy rate were higher in the MyoSure group (13.14 ± 7.85 months vs 16.26 ± 8.22 months, P = 0.040; 65.12% vs 54.55%, P = 0.045), but there was no significant difference in the term live birth rate, premature birth rate, or abortion rate between the two groups. CONCLUSION: MyoSure has advantages of a shortened operative time and improvement in reproductive outcomes such as pregnancy rate. However, for type II myomas, MyoSure has limitations, and a comprehensive evaluation before the procedure is required.

Too big? A review of methods for removing large endometrial polyps in office minihysteroscopy - broadening the indications for the procedure in the COVID-19 pandemic.

Hysteroscopy is the gold standard for the diagnosis and treatment of endometrial polyps. For small polyps (less than 2 cm) minihysteroscopy can be performed in an office setting. Patients with polyps larger than 2 cm are usually referred for a standard resectoscope procedure in the operation room (OR) under general anaesthesia. Those patients are exposed to longer hospital stay and possible complications of the anaesthesia. Furthermore, they usually have longer contact with many medical staff members. Limiting the time of contact as well as the number of staff involved in the procedure is particularly important during the COVID-19 pandemic. For this reason, minihysteroscopy in an office setting should be the first choice in every possible indication. We present the methods that may be useful for removing even large polyps in minihysteroscopy. The advantages and disadvantages of every procedure are discussed.

Mini-resectoscope vs morcellator for in-office hysteroscopic myomectomy: Evaluation of results and patient satisfaction.

INTRODUCTION: The development of hysteroscopic techniques has led to an advance in submucous myoma treatment, offering a safe and effective minimally invasive alternative. Our objective was to compare the results of hysteroscopic myomectomy when using whether the mini-resectoscope or the MyoSure morcellator, as well as patient satisfaction after the procedure. MATERIAL AND METHODS: A prospective, cross-sectional, observational study including 80 patients distributed into two groups: Mini-Resectoscope group (MRG) or MyoSure group (MSG), depending on the instrument used for the in-office hysteroscopic myomectomy. Resection time, pain during entry, pain during resection, number of resections required, complete resection, and total satisfaction were recorded. RESULTS: MSG had statistically significant shorter time of entrance. There were no other statistically significant differences between groups. CONCLUSIONS: In-office hysteroscopic myomectomy is associated with high levels of patient satisfaction, without differences between the mini-resectoscope or the MyoSure, allowing high rates of complete resection using both instruments. Thus, it is a feasible technique which could be performed with both instruments, depending on the operator's expertise.

Conservative cesarean scar pregnancy treatment: local methotrexate injection followed by hysteroscopic removal with hysteroscopic tissue removal system.

OBJECTIVE: To describe a conservative cesarean scar pregnancy (CSP) treatment in a patient with the desire for future pregnancy. To date, there is no gold standard for the management of a viable CSP. There is a wide range of treatment options that include major surgery and minimally invasive procedures. Moreover, after a minimally invasive treatment, the gestational sac may be visible at ultrasound for >6 months. The described technique may be useful to avoid complications related to the use of energy with a large reduction in operative times. DESIGN: Description of the technique with narrated video footage. SETTING: Academic tertiary hospital. PATIENT(S): A 31-year-old woman with a previous cesarean section was referred to our clinic with lower abdominal pain. Transvaginal ultrasound revealed a gestational sac with a viable embryo located in the anterior isthmic region, suggestive of CSP at 9 weeks of gestation. Appropriate counseling describing the two diametrically opposite clinical management options was performed, and the patient decided to terminate the pregnancy. Informed consent was obtained from the patient. INTERVENTION(S): Hysteroscopy was performed under local anesthesia in an outpatient setting, using a 2.9-mm Hopkins II Forward-Oblique Telescope 30° endoscope (Karl Storz, Tuttlingen, Germany) with a 4.3-mm inner sheath and 5F instruments. A 3.7F needle (Deflux metal needle; Oceana Therapeutics, Edison, NJ) was pushed into the myometrial tissue surrounding the implantation site of the gestational sac at four different points. Six additional injections were performed into the gestational sac, and 50-mg methotrexate was injected. The appropriate follow-up was performed to determine the success of the procedure. ß-Human chorionic gonadotropin was dosed weekly until negative. After 6 weeks, to remove the avascular trophoblastic remnants found at ultrasound evaluation, the patient underwent hysteroscopic removal with a 6-mm TruClear hysteroscopic tissue removal system (Medtronic Parkway, Minneapolis, MN). A contemporary transabdominal ultrasound was performed to minimize surgical risks. MAIN OUTCOME MEASURE(S): Complete and conservative CSP treatment with the absence of surgical complications. RESULT(S): Conservative cesarean scar pregnancy treatment was performed successfully with primary local methotrexate injection followed, after 6 weeks, by hysteroscopic removal of the CSP remnants with the TruClear hysteroscopic tissue removal system. The first procedure lasted 6 minutes, whereas hysteroscopic removal of the CSP lasted 5 minutes. Both procedures were performed in an outpatient setting, and no complications were detected during and after the treatments. The patient reported good health at the 1-month follow-up visit, and the ultrasound showed an empty isthmocele (Fig. 1). CONCLUSION(S): Primary local methotrexate injection followed by hysteroscopic removal of the CSP remnants with the hysteroscopic tissue removal system may be a valuable treatment for women who desire pregnancy in the near future. This combined technique may avoid potential complications, such as thermal-induced myometrial injuries or uterine perforation. Moreover, the operator has the possibility to perform an under-vision procedure with a lower incidence of intraoperative and postoperative bleeding. Because it does not reduce fertility/pregnancy rate, this technique should be a valid option in patients who desire future pregnancy.

Office hysteroscopic morcellation service: Evaluation of women experience and factors affecting satisfaction.

OBJECTIVES: To evaluate the hysteroscopic morcellation service in office-setting in everyday practice outside the context of clinical trials. The primary objectives were to assess level of acceptability and factors affecting women satisfaction. The secondary objectives included assessment of complete resection rate, complications rate, pain score during the procedure and on discharge, and the correlation between the lesion size as subjectively estimated by the hysteroscopists versus the volume of morcellated tissues as semi-quantitively measured by the laboratory. METHOD: The clinical data was compiled for 287 consecutive women undergoing hysteroscopic morcellation in office-setting from 1 January 2017 to 31 March 2021 in a teaching hospital in the UK. A questionnaire, formulated on the Visual Analogue Scale (VAS), was completed immediately after the procedure by the last 110 women undergoing the procedure. RESULTS: The mean age of the cohort (n = 278) was 54.5 years (SD ± 12.5). Only 7 (2.4%) women required two-stage procedure because of size (fibroid ≥ 4 cm), vascularity or multiplicity of lesions. No complications were encountered. The majority of women completing the questionnaire (n = 110) found office procedure acceptable (105, 95.5%, VAS ≥ 7), were willing to have it again if indicated (102, 92.7%, VAS ≥ 7), would recommend it to family and friends (105, 95.5%, VAS ≥ 7) and confirmed receiving adequate preoperative information by doctors and nurses (107, 97.3%, VAS ≥ 7). The level of preoperative explanation and information-giving showed significant (p < 0.01) positive correlation with the level of acceptability and recommendation to others and significant (p = .007) negative correlation with the pain experienced on discharge. The median (IQR) estimated size at hysteroscopy was 2 cm (1-6 cm) for polyps and 2.5 cm (1-4 cm) for fibroid. The median (IQR) volume of the morcellated specimens as estimated by laboratory was 2000 mm3 (1100-3800 mm3). The estimated size at hysteroscopy was positively correlated with the specimen's volume (Spearman's rho (r) = 0.31, 95% = CI, 0.14-0.45, p < 0.01). CONCLUSION: Office hysteroscopic morcellation is associated with high satisfaction rate and low pain score on discharge. Good preoperative explanation and information-giving was the crucial factor that increased women satisfaction. Subjective estimation of lesion size by hysteroscopists may be an accurate and simple method of measurement.

Hysteroscopic tissue removal system (MyoSure) for the resection of polyps, sub-mucosal leiomyomas and retained products of conception in an out-patient setting: A single UK institution experience.

PURPOSE: The present study aimed to elucidate the hysteroscopic tissue removal system (MyoSure) efficacy and safety amongst uterine cavity pathologies (UCPs), and to determine its feasibility in an outpatient setting. We also sought to identify possible factors that could adversely affect complete lesion excision. METHODS: 124 women underwent MyoSure procedure and 135 UCPs were excised, between January 2017 and January 2018. The MyoSure efficacy was evaluated, and potential factors correlated with increased incomplete excision rate were assessed, using both univariate and multivariate analysis. RESULTS: The overall MyoSure excision rate was 94.8%. 107/109 polyps and 14/19 leiomyomas were completely resected with a success rate of 98.1% and 73.7% respectively. The complete excision rate amongst retained products of conception (RPOC) cases was 100%. A significant correlation between leiomyomas and incomplete excision was found when compared to polyps and RPOC (p < 0.001). In this cohort, type II leiomyomas (OR = 1.8, p = 0.01) and maximal diameter > 4 cm (OR = 1.6, p = 0.02) were independently correlated with incomplete leiomyomas excision. Nine out of 124 women (7.3%) experienced severe pain during the procedure, while 17% and 73% reported moderate and mild pain respectively. Furthermore, 99% of women (123/124) would undergo the procedure again in the future or recommend it to a friend, for a similar pathology removal. CONCLUSIONS: MyoSure is an efficient, safe and feasible operative hysteroscopic procedure in an office-outpatient setting. It is associated with high patient acceptability and, it is highly recommended by the vast majority of the women. Large, and type II leiomyomas are seemingly procedure limitations.