Reproductive and obstetrical outcomes after treatment of retained products of conception: hysteroscopic removal vs ultrasound-guided electric vacuum aspiration, a prospective follow-up study.

BACKGROUND: Traditionally, curettage has been the most widely performed surgical intervention for removing retained products of conception. However, hysteroscopic removal is increasingly performed as an alternative because of the potentially lower risk of intrauterine adhesions and higher rates of complete removal. Until recently, studies comparing curettage with hysteroscopic removal regarding reproductive and obstetrical outcomes were limited, and data conflicting. OBJECTIVE: This study aimed to assess reproductive and obstetrical outcomes in women wishing to conceive after removal of retained products of conception by hysteroscopy or ultrasound-guided electric vacuum aspiration. STUDY DESIGN: This was a prospective long-term follow-up study, conducted in 3 teaching hospitals and 1 university hospital. Patients were included from April 2015 until June 2022 for follow-up, either in a randomized controlled, nonblinded trial on the risk of intrauterine adhesions after removal of retained products of conception, or in a cohort alongside the randomized trial. Women with an ultrasonographic image suggestive of retained products of conception ranging from 1 to 4 cm were eligible. Surgical procedures in the randomized controlled trial were hysteroscopic morcellation or ultrasound-guided electric vacuum aspiration. In the cohort study, hysteroscopic treatment included hysteroscopic morcellation or cold loop resection compared with ultrasound-guided electric vacuum aspiration. RESULTS: A total of 261 out of 305 patients (85.6%) were available for follow-up after removal of retained products of conception, resulting in a cohort of 171 women after hysteroscopic removal and 90 women after removal by ultrasound-guided vacuum aspiration. Respectively, 92 of 171 women (53.8%) in the hysteroscopic removal group and 56 of 90 (62.2%) in the electric vacuum aspiration group wished to conceive (P=.192). Subsequent pregnancy rates were 88 of 91 (96.7%) after hysteroscopic removal and 52 of 56 (92.9%) after electric vacuum aspiration (P=.428). The live birth rates were 61 of 80 (76.3%) and 37 of 48 (77.1%) after hysteroscopic removal and electric vacuum aspiration, respectively (P=.914), with 8 of 88 pregnancies (9.1%) in the hysteroscopic removal group and 4 of 52 (7.7%) in the electric vacuum aspiration group still ongoing at follow-up (P=1.00). The median time to conception was 8.2 weeks (interquartile range, 5.0-17.2) in the hysteroscopic removal group and 6.9 weeks (interquartile range, 5.0-12.1) in the electric vacuum aspiration group (P=.262). The overall placental complication rate was 13 of 80 (16.3%) in the hysteroscopic removal group and 11 of 48 (22.9%) in the electric vacuum aspiration group (P=.350). CONCLUSION: Hysteroscopic removal and ultrasound-guided electric vacuum aspiration of retained products of conception seem to have no significantly different effects on subsequent live birth rate, pregnancy rate, time to conception, or pregnancy complications. Reproductive and obstetrical outcomes after removal of retained products of conception are reassuring, albeit with a high risk of placental complications.

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.

Efficacy of Oral Nifedipine, Naproxen, or Placebo for Pain Relief During Diagnostic Hysteroscopy in an Office Setting: A Randomized Pilot Study.

STUDY OBJECTIVE: To compare nifedipine, naproxen, or placebo for pain relief during diagnostic hysteroscopy. DESIGN: Double-blind, randomized controlled pilot study. SETTING: University hospital. PATIENTS: Women scheduled for office diagnostic hysteroscopy (n = 60). INTERVENTIONS: Women received nifedipine (2 tablets of 10 mg), naproxen (2 tablets of 250 mg), or placebo (2 tablets of 500 mg lactose) 30 to 60 minutes prior to hysteroscopy. MEASUREMENTS AND MAIN RESULTS: Sixty patients were enrolled in the study (21 in the nifedipine group, 19 in the naproxen group, and 20 in the placebo group). The median pain scores during hysteroscope insertion, measured on a Visual Analog Scale (VAS), were 1 (interquartile range (IQR) 0-0), 2 (0-4) and 1 (0-1) in the nifedipine, naproxen and placebo group, respectively (P,14). The median VAS scores during hysteroscopy were 5 (IQR 2-7), 5 (4-8) and 5 (3-7) in the nifedipine, naproxen and placebo group, respectively (P,73). The median VAS scores immediately after hysteroscopy were 2 (IQR 0-4), 3 (0-6) and 3 (1-5) in the nifedipine, naproxen and placebo group, respectively (P,40). The median VAS scores 30 minutes after hysteroscopy were 1 (IQR 0-2), 1 (0-1) and 1 (0-2) in the nifedipine, naproxen and placebo group, respectively (P,63). Hysteroscope insertion failed in 1 case (naproxen group) because of cervica`l stenosis (P,32). Flushes, fatigue and vertigo, 30 minutes after the procedure, were significantly more prevalent in the nifedipine group compared to the naproxen (p < .001, p,03, p,03, respectively) and the placebo group (p < .001, p,01, p,01, respectively). Palpitations occurred only in the nifedipine group (p < .001). The day after the procedure, the headache was most prevalent in the nifedipine group compared to the naproxen group (p,001) and the placebo group (p,001). CONCLUSION: In our pilot study, pain relief and success rates for office diagnostic hysteroscopy were not significantly different between nifedipine, naproxen, and placebo. Nifedipine was associated with more, albeit tolerable, side-effects.

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.

Safety and Efficacy of a Novel Barrier Film to Prevent Intrauterine Adhesion Formation after Hysteroscopic Myomectomy: The PREG1 Clinical Trial.

STUDY OBJECTIVE: To evaluate the safety and potential efficacy of a novel degradable polymer film (DPF) designed to act as a 7-day barrier to prevent intrauterine adhesions (IUAs) after hysteroscopic myomectomy. DESIGN: A prospective single-arm, first-in-human clinical study. SETTING: Multicenter study involving 6 centers in France, Belgium, and the Netherlands. PATIENTS: Women aged 40 years or older with no plans to conceive who qualified for hysteroscopic myomectomy (at least 1 10-mm type 0, 1, or 2 myoma) and had a sounded length of the uterine cavity (fundus to exocervix) ranging between 6 cm and 9 cm were considered eligible for the study. INTERVENTIONS: The DPF was inserted after hysteroscopic transcervical myoma resection. The women were followed up by a telephone call at 30 days and second-look hysteroscopy 4 to 8 weeks after the procedure. MEASUREMENTS AND MAIN RESULTS: The chosen safety outcome measures were uterine perforation or cervical trauma at the time of the DPF insertion and unexpected fever, pain, or bleeding beyond 48 hours and up to 30 days after insertion, whereas the outcome measure for efficacy was the absence of IUAs on second-look hysteroscopy. A total of 23 women participated in the study. There were no incidents of uterine perforation or cervical trauma at the time of the DPF insertion. There were no reported adverse effects attributable to the DPF. On second-look hysteroscopy, 20 (87%) of the 23 women had no IUAs. CONCLUSION: The DPF is a novel, easy-to-apply, and acceptable device to prevent IUAs, with very promising initial safety and efficacy data.

The use of an intrauterine balloon in preventing adhesion recurrence after hysteroscopic adhesiolysis: a feasibility study.

We aimed to evaluate the feasibility of a heart-shaped intrauterine balloon as antiadhesion method immediately after hysteroscopic adhesiolysis in terms of surgeon's and patient's experience. This feasibility study was performed at the Ghent University Hospital (Belgium) from 2018 to 2020. A heart-shaped intrauterine balloon was inserted in 10 women immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis. Insertion and removal of the balloon was easy in 7 women out of 10 (5-point Likert scale), and successful in all cases. The median pain score during balloon wearing on a visual analogue scale (VAS) was 1.7 (IQR 1.0-4.2). Seven out of 10 women were satisfied (5-point Likert scale). Eight out of 10 women would probably or certainly recommend the procedure to a friend (5-point Likert scale) and would use the balloon again. The heart-shaped intrauterine balloon as antiadhesion method is feasible in terms of surgeon's and patient's experience. Designing a proper Randomised Controlled Trial (RCT) is worth the effort. Clinical trial registration: https://clinicaltrials.gov (NCT03446755). Initial release on 27th February 2018.IMPACT STATEMENTWhat is already known on this subject? Intrauterine adhesion (IUA) reformation is high and different methods to prevent this subsequent to an operative hysteroscopy have been assessed. The use of antiadhesion gel, acting as a mechanical barrier, may decrease the occurrence of IUAs compared to no treatment or placebo. A heart-shaped intrauterine balloon is another example of a mechanical barrier. A small number of studies, of varying quality and with heterogeneous results, have been performed. A proper RCT, comparing the intrauterine balloon to no treatment or placebo, is needed.What the results of this study add? The heart-shaped intrauterine balloon as antiadhesion method is feasible in terms of surgeon's and patient's experience.What the implications are of these findings for clinical practice and/or further research? Designing a proper RCT is worth the effort.

Reproductive and Obstetric Outcomes After Hysteroscopic Removal of Retained Products of Conception.

STUDY OBJECTIVE: To evaluate the reproductive outcomes in women treated for retained products of conception (RPOC) by hysteroscopy (morcellation vs loop resection). DESIGN: Cohort study. SETTING: A teaching and university hospital. PATIENTS: Patients included in a previous randomized controlled trial on hysteroscopic removal of RPOC comparing morcellation (n = 46) with loop resection (n = 40). INTERVENTIONS: Hysteroscopic morcellation versus loop resection. MEASUREMENTS AND MAIN RESULTS: The primary outcome measures were live birth and pregnancy complications (including abnormal placentation [placenta accreta/increta/percreta], placenta previa, vasa previa, retained placenta after delivery or incomplete expulsion with the need for manual removal or curettage, and RPOC), uterine rupture, and other complications (blood loss, preterm labor, preterm premature rupture of membranes, hypertensive disorders of pregnancy, and intrauterine growth restriction). The live birth rate was 88.9% in the morcellation group and 68.2% in the loop resection group (p = .09). Uterine rupture occurred in 1 patient in the morcellation group (4.2%) (p = 1.00). Placental complications were found in 20.8% and 22.2% of the hysteroscopic morcellation and loop resection groups, respectively (p = .33), and other pregnancy complications were seen in 33.3% and 16.6% of the 2 groups (p = .33). The secondary outcome was time to pregnancy. The median time to pregnancy was 14 weeks (interquartile range [IQR], 5-33 weeks) in the morcellation group and 15 weeks (IQR, 6-37 weeks) in the loop resection group (p = .96). CONCLUSION: Hysteroscopic removal of RPOC seems to have no detrimental effect on reproductive outcome and no significant effect on pregnancy rate.

Articulated Instruments and 3D Visualization: A Synergy? Evaluation of Execution Time, Errors, and Visual Fatigue.

Objective. The introduction of advanced endoscopic systems, such as the Storz Image1S and the Olympus Endoeye, heralds a new era of 3-dimensional (3D) visualization. The aim of this report is to provide a comprehensive overview of the neurophysiology of 3D view, its relevance in videoscopy, and to quantify the benefit of the new 3D technologies for both rigid and articulated instruments. Method. Sixteen medical students without any laparoscopic experience were trained each for a total of 27 hours. Proficiency scores were determined for rigid and articulated instruments under 2D and 3D visualization conditions. Results. A reduction in execution time of 14%, 28%, and 36% was seen for the rigid instruments, the da Vinci, and Steerable instruments, respectively. A reduction in errors of 84%, 92%, and 87% was seen for the rigid instruments, the da Vinci, and Steerable instruments, respectively. Conclusion. 3D visualization greatly augments endoscopic procedures. The advanced endoscopic systems employed in the recent study caused no visual fatigue or discomfort. The benefit of 3D was most distinct with articulated instruments.

Hysteroscopic Tissue Removal Systems: A Randomized In Vitro Comparison.

STUDY OBJECTIVE: To compare polyp resection time and myoma resection rate using 2 hysteroscopic tissue removal systems. DESIGN: Prospective randomized in vitro trial (Canadian Task Force classification I). SETTING: Clinical skills laboratory of a non-university teaching hospital. SAMPLES: Polyp surrogate and myoma tissue. INTERVENTIONS: Hysteroscopic tissue removal with the TRUCLEAR system, using the TRUCLEAR INCISOR 2.9 (TI), TRUCLEAR INCISOR Plus (TIP), or TRUCLEAR ULTRA Plus (TUP) device, and the MyoSure system, using the MyoSure Lite (ML), MyoSure Classic (MC), or MyoSure XL (MXL) device. MEASUREMENTS AND MAIN RESULTS: Forty-two fragments of umbilical cord weighing 5 g, as a surrogate for polyps, were randomly allocated to 4 types of devices (TI, TIP, ML, and MC). Three consecutive fragments were removed using a single device. In addition, 18 pieces of myoma tissue were divided into 2 equal parts and randomly allocated to 2 types of devices (TUP and MXL). A new device was used for each fragment. Each type of device was tested at 2 vacuum settings. When removing 1 polyp, the TIP (median time, 2:33 minutes [interquartile range (IQR), 1:32-3:27 minutes]), the MC (median time, 3:15 minutes [IQR, 2:42-3:42 minutes]), and the ML (median time, 3:00 minutes [IQR, 2:16-3:25 minutes]) performed significantly faster than the TI (median time, 14:09 minutes [IQR, 13:44-14:36 minutes]), by 84%, 78%, and 82% respectively (p < .001). The TIP performed 80% faster than the TI (median time, 2:27 minutes [IQR, 1:45-2:46 minutes] vs 10:37 minutes [IQR, 8:38-13:44 minutes]; p < .001) when removing a second polyp. For removal of a third polyp, the TIP performed significantly faster (median time, 2:22 minutes [IQR, 1:32-3:07 minutes]) than the TI (median time, 8:35 minutes [IQR, 7:37-9:03 minutes]) and the ML (median time, 10:02 minutes [IQR, 9:51-10:18 minutes]), by 74% and 78%, respectively (p < .001). The performance of the ML decreased (p < .001) during removal of 3 consecutive tissue samples. For myoma tissue, the estimated mean resection rate of the TUP (2.96 g/min [95% confidence interval (CI), 2.32-3.77 g/min]) was 24% (95% CI 0.2%-52.4%) higher than the mean resection rate of the MXL (2.39 g/min [95% CI 1.87-3.05 g/min]; p = .048). The resection rate of the MXL adjusted for vacuum setting declined by 3% per unit increase in myoma volume (95% CI, -0.6% to -5.7%; p = .02). For the TUP, no linear association was found (0.4%; 95% CI, -2.1% to 3.0%; p = .72). CONCLUSION: In vitro comparison of the removal of surrogate polyps showed that although the larger TIP, MC, and ML devices were significantly faster than the TI for removal of 1 polyp, only the TIP was consistently faster than the TI for consecutive removal of polyps. The performance of the ML decreased significantly during removal of 3 consecutive tissue samples, making it slower than the TIP with a similar window size in the third run. For removal of myoma tissue, the resection rate of the TUP was significantly higher than that of the MXL, and the resection rate of the MXL decreased with increasing myoma volume. In vitro testing can provide useful information on the time and rate of hysteroscopic tissue removal.

Hysteroscopic Morcellation Versus Loop Resection for Removal of Placental Remnants: A Randomized Trial.

STUDY OBJECTIVE: To compare hysteroscopic morcellation with loop resection for the removal of placental remnants in terms of procedure time, adverse events, tissue availability, histology results, short-term effectiveness, and postoperative adhesions. DESIGN: A randomized controlled trial (Canadian Task Force classification I). SETTING: A teaching and university hospital. PATIENTS: Women with placental remnants. INTERVENTIONS: Hysteroscopic morcellation with the TRUCLEAR 8.0 Tissue Removal System (Smith & Nephew, Inc, Andover, MA) or loop resection with a rigid 8.5-mm bipolar resectoscope (Karl Storz GmbH, Tuttlingen, Germany). MEASUREMENTS AND MAIN RESULTS: Forty-six and 40 women were included in the hysteroscopic morcellation and resection groups, respectively. The median operating time was significantly shorter for hysteroscopic morcellation compared with loop resection (6.2 minutes [interquartile range, 4.0-11.2 minutes] vs 10.0 minutes [5.8-16.4 minutes], p = .023). Both operating time and total procedure time, corrected for the diameter of the placental remnants, were significantly reduced for hysteroscopic morcellation compared with loop resection, by 40% (95% confidence interval, 15%-58%; p = .005) and 22% (95% CI, 5%-37%; p = .014), respectively. No adverse events occurred during hysteroscopic removal. Perforation at dilation in 8 cases of the hysteroscopic morcellation group resulted in 2 procedure discontinuations and 1 incomplete procedure. Incomplete removal was found in 1 uncomplicated hysteroscopic morcellation procedure and 2 resection procedures. Pathology results confirmed the presence of placental remnants in 27 of 40 (67.5%) and 26 of 37 (70%) patients in the hysteroscopic morcellation and resection groups, respectively. Second-look hysteroscopy showed de novo intrauterine adhesions in 1 of 35 patients (3%) in the hysteroscopic morcellation group and 1 of 30 (3%) patients in the resection group. CONCLUSION: Hysteroscopic morcellation is a faster alternative than loop resection. Both techniques are safe and show high rates of complete removal and tissue availability and low rates of de novo intrauterine adhesions.

Removal of Endometrial Polyps: Hysteroscopic Morcellation versus Bipolar Resectoscopy, A Randomized Trial.

STUDY OBJECTIVES: To compare hysteroscopic morcellation with bipolar resectoscopy for removal of endometrial polyps, in terms of procedure time, peri- and postoperative adverse events, tissue availability, and short-term effectiveness. DESIGN: Multicenter, open label, randomized controlled trial (Canadian Task Force classification I). SETTING: Day surgery setting of a teaching and a university hospital. PATIENTS: Women with larger (≥1 cm) endometrial polyps. INTERVENTIONS: Hysteroscopic morcellation with the TRUCLEAR 8.0 Tissue Removal System or bipolar resectoscopy with a rigid 8.5-mm bipolar resectoscope. MEASUREMENTS AND MAIN RESULTS: Eighty-four women were included in the intention-to-treat analysis. Median operating time was 4.0 min (range: 2.5-7.1) and 6.0 min (range: 3.8-11.7) in the hysteroscopic morcellation and resectoscopy groups, respectively. Operating time was reduced by 38% (95% confidence interval: 5%-60%; p = .028) in the hysteroscopic morcellation group. Procedure time, which was defined as the sum of the installation and operating time, tended to be less for the hysteroscopic morcellation group (median 9.5 min [range: 7.6-12.2] vs 12.2 min [range: 8.8-16.0]; p = .072). Perforation occurred at dilation or hysteroscope (re)introduction in 3 patients of the resectoscopy group, resulting in procedure discontinuation or prolongation of hospital stay. Perforation occurred at dilation in 1 patient in the hysteroscopic morcellation group; however, the procedure was successfully completed. Postoperatively, 2 patients of the hysteroscopic morcellation group were diagnosed with a urinary tract infection. Tissue was available for pathology analysis in all patients, except for 2 patients in the resectoscopy group in whom the procedure was discontinued due to perforation. CONCLUSION: Hysteroscopic morcellation is a fast, effective, and safe alternative to bipolar resectoscopy for removal of endometrial polyps.

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.

An alternative approach for removal of placental remnants: hysteroscopic morcellation.

STUDY OBJECTIVE: To evaluate our initial experience with hysteroscopic morcellation for removal of placental remnants. DESIGN: Retrospective case series (Canadian Task Force classification II-3). SETTING: University hospital and 2 teaching hospitals. PATIENTS: Women with histologic confirmation of placental remnants after miscarriage, termination of pregnancy, or delivery. INTERVENTION: From January 2005 to May 2010, hysteroscopic morcellation was used for removal of placental remnants. Retrospective review of medical records was performed. MEASUREMENTS AND MAIN RESULTS: Analysis of 105 procedures was performed. In 99 procedures (94.3%), placental remnants were removed successfully at the first approach, and 90 procedures (85.7%) were without any adverse events. In 6 patients (5.7%), uterine perforation occurred, in 4 during cervical dilation and in 2 during the hysteroscopic procedure. Postoperatively, 3 patients had fever, 1 had hemorrhage, and 1 had abdominal pain. Routine second-look hysteroscopy in 23 patients revealed mild intrauterine adhesions in 1 patient (4.4%). CONCLUSION: Hysteroscopic morcellation seems to be an effective technique for management of placental remnants. Future studies comparing various surgical treatment methods are needed to define factors that influence the ability to obtain the safest and most complete removal of placental remnants because this remains a challenging pregnancy-related condition.

Hysteroscopic morcellation vs. curettage for removal of retained products of conception: a multicenter randomized controlled trial.

OBJECTIVE: To study the comparison between hysteroscopic morcellation (HM) of retained products of conception (RPOC) with ultrasound (US)-guided electric vacuum aspiration in terms of intrauterine adhesion (IUA) formation, efficacy, and complications. DESIGN: A randomized controlled, nonblinded trial. SETTING: Three teaching hospitals and one university hospital from April 2015 to June 2022. PATIENTS: A total of 133 women with RPOC on US, ranging from 1-4 cm, were randomized to receive either HM or electric vacuum aspiration. INTERVENTION: Hysteroscopic morcellation was performed with the TruClear System (Medtronic, Minneapolis, MN, USA). Electric vacuum aspiration was performed using an 8- or 10-mm flexible plastic Karman cannula under US guidance. Women allocated to vacuum aspiration underwent the procedure as soon as possible. MAIN OUTCOME MEASURES: In the HM group, an office diagnostic hysteroscopy was planned a minimum of 6 weeks after the end of pregnancy, followed by retained product of conception removal at least 8 weeks after the end of the pregnancy. Postoperatively, an office second-look hysteroscopy was scheduled to assess the primary outcome of IUAs. RESULTS: Postoperative IUAs were seen in 14.3% (9/63) of patients in the HM group and 20.6% (13/64) of patients in the vacuum aspiration group (-6% [-19.1% to 7.1%]). Significantly more RPOC were removed completely by HM compared with vacuum aspiration (95.2% vs. 82.5% (-14% [-24.9% to -3.1%]), and additional operative hysteroscopy was less frequently necessary in the HM group (12.5%) compared with the vacuum aspiration group (31.3%) (-20.1% [-34.3% to -6%]). The median operating time was shorter for vacuum aspiration compared with HM (5.80 minutes vs. 7.15 minutes). No differences were observed between HM and vacuum aspiration for the occurrence of intraoperative or postoperative complications (5.5% vs. 5.0% and 2.7% vs. 1.3%, respectively). CONCLUSION: In our randomized controlled trial, no significant differences were found in the occurrence of IUAs and complications. However, the RPOC were more often completely removed by HM than vacuum aspiration, and the HM group required fewer additional hysteroscopic treatments. CLINICAL TRIAL REGISTRATION NUMBER: NTR4923 (https://trialsearch.who.int/Trial2.aspx?TrialID=NTR4923). Date of registration: November 23, 2014, date of initial participant enrollment: January 1, 2015.

Operative hysteroscopy versus ultrasound-guided electric vacuum aspiration for removal of retained products of conception: A prospective cohort study.

Objectives: To compare intrauterine adhesion (IUA) formation after hysteroscopic removal (HR) of retained products of conception (RPOC) with IUA formation after ultrasound-guided electric vacuum aspiration (EVA) and externally validate the outcomes of an RCT. Study design: This prospective cohort study was conducted from April 2015 until June 2022 in 2 Dutch teaching hospitals and one Belgian university hospital. Women opting for EVA underwent the procedure as soon as possible. In the HR group, the therapeutic hysteroscopy was performed at least eight weeks after the end of pregnancy. Postoperatively, an office second-look hysteroscopy was offered to all patients. Women were included if they had been diagnosed with RPOC ranging from 1 to 4 cm on ultrasound and did not want to participate in the RCT. EVA was performed using a Karman cannula. Operative hysteroscopy consisted either of hysteroscopic morcellation with the TruClear™ System or the Intrauterine BIGATTI Shaver or cold loop resection with a bipolar resectoscope. Results: Of 178 included women, 124 were treated with HR and 28 with EVA. Outcomes of HR and EVA did not differ significantly in terms of complications (5.6 % vs 3.6 %; p = 1.00). Second-look hysteroscopy showed IUAs in 14 of 91 women (15.4 %) after HR and in 1 of 16 (6.3 %) after EVA (p = .461). Completeness of removal was significantly higher (90.1 %) after HR than after EVA (68.8 %) (p = .035). Additional operative hysteroscopy was required in 14.3 % of the HR group versus 37.5 % in the EVA group (p = .036). Conclusion: In our cohort study, no significant differences in IUAs or complications were found. RPOC removal with HR was more often complete than removal with EVA, and additional therapeutic hysteroscopy was less frequently required after HR. These findings need to be correlated with those of RCTs. Clinical trial registration: The study was registered in de Dutch Trial Register (NTR4923). Date of registration 23-11-2014. Date of first enrollment 01-01-2015. https://trialsearch.who.int/Trial2.aspx?TrialID=NTR4923.

Operative hysteroscopy in the minimally invasive management of interstitial pregnancy and interstitially retained products of conception: A case report and systematic literature review.

OBJECTIVE: An interstitial pregnancy is a rare form of ectopic pregnancy. Diagnosis and management can be challenging. Treatment often involves invasive uterine surgery. Conservative options such as methotrexate are important alternatives nowadays. The aim of this review is to investigate the role of operative hysteroscopy in the organ and fertility preserving management of interstitial pregnancy and interstitially retained products of conception (RPOC). METHODS: A case is presented in which interstitially RPOC were removed using hysteroscopic morcellation under laparoscopic guidance. Consequently, a systematic literature review was performed.Medline, Embase and The Cochrane Library were used as literature resources. RESULTS: In the literature review, 14 case reports in which operative hysteroscopy was part of the minimally invasive treatment of interstitial pregnancy and interstitially RPOC of which 11 were studied. Of these 14 cases, 11 were reported as being successful. Different techniques such as laparoscopy and suction curettage were associated. Various hysteroscopic instruments were used, hysteroscopic graspers most commonly. Reported complications were uterine perforation during suction curettage and incomplete hysteroscopic resection. Analysis of the cases did not demonstrate a clear difference between different approaches concerning safety, efficacy or subsequent fertility and pregnancy outcomes. CONCLUSION: With the growing experience in hysteroscopy and the development of novel techniques and devices, such as hysteroscopic morcellation, operative hysteroscopy has a promising role in the minimally invasive management of interstitial pregnancy and interstitially RPOC. (Laparoscopically guided) operative hysteroscopy might be a convenient approach to avoid blind curettage and related complications such as uterine perforation.

Hysteroscopic morcellation versus bipolar resection for removal of type 0 and 1 submucous myomas: A randomized trial.

OBJECTIVES: To compare hysteroscopic morcellation with bipolar resection for the removal of submucous type 0 and 1 myomas, in terms of procedure time (primary outcome), adverse events, tissue availability, short term effectiveness and postoperative adhesion formation (secondary outcomes). STUDY DESIGN: The study was performed from May 2011 to May 2018 in the Catharina hospital (Eindhoven, the Netherlands) and the Ghent University hospital (Ghent, Belgium). Women with type 0 and 1 submucous myomas up to 3 cm were randomized to hysteroscopic morcellation with the TruClearTM 8.0 Tissue Removal System or to bipolar resection with a rigid 8.5-mm resectoscope. Skewed time variables were log-transformed and analyzed with the Student t-test. Multiple linear regression analysis was performed to assess the effect of myoma diameter on operating time. RESULTS: Forty-five and 38 women were included in the hysteroscopic morcellation and resection group, respectively. The median operating time was significantly shorter for hysteroscopic morcellation compared with resection (9.2 min [interquartile range 5.6-14.4] versus 13.4 min [interquartile range 8.6-17.5], P = .04). In the morcellation group, operating time, corrected for the myoma diameter, was reduced by 26 % (95 % CI 5-43%; P = .02). The median setup time was significantly longer in the morcellation group (5.2 min [interquartile range 4.2-6.9] versus 3.8 min [interquartile range 3.3-5.3], P = .006). The median total procedure time was not significantly different between the two techniques (14.4 min [interquartile range 11.4-19.2] versus 17.3 [interquartile range 12.7-23.8], P = .18). Two procedures of the morcellation group were converted to bipolar resection because of the myoma hardness. Complete resection was found in 89 % of the morcellation group and 95 % of the resection group. Adverse events occurred in 3 patients of the morcellation group, namely a fluid deficit > 2500 mL with the need of potassium suppletion, an asystolic vasovagal response after conversion to resection and postoperative fever requiring antibiotics. Tissue was available for pathology analysis in all cases. Routine second-look hysteroscopy performed in one center showed no intrauterine adhesions. CONCLUSION: Overall, there is no difference in total procedure time between hysteroscopic morcellation using the TruClearTM system compared to bipolar resection for the removal of smaller type 0 and 1 submucous myomas. Although hysteroscopic morcellation is faster, its setup time is longer. Calcified myomas can be challenging and fluid deficit remains a limiting factor.

Hysteroscopy in the Netherlands and Flanders: A survey amongst practicing gynaecologists.

OBJECTIVE: To gain insight in the current ideas on, and implementation of hysteroscopy amongst practicing gynaecologists in the Netherlands and Flanders. STUDY DESIGN: In August 2016 an electronic questionnaire was sent to practising gynaecologist members of the Dutch (N = 591) and Flemish (N = 586) Society of Obstetrics and Gynaecology. RESULTS: The response rate for the Netherlands was 15.4% (91/591), and for Flanders 27.0% (158/586). Responding gynaecologists have a preference for hysteroscopy for diagnosing and treating most intrauterine pathology. Flemish respondents are more hesitant in opting for hysteroscopy instead of curettage for treatment of polyps and placental remnants. There appears to be a wide diffusion of diagnostic and basic operative hysteroscopy. In contrast to Flanders, responding hysteroscopists from the Netherlands more often perform office hysteroscopic procedures. Hysteroscopic procedures, and office procedures in particular, are now educated during residency. Therefore, recently graduated gynaecologists have a preference for this technique. CONCLUSION: Our survey confirms that nowadays the focus of treating intrauterine pathology is on less invasive techniques and preserving the uterus. Dutch responding hysteroscopists have more expertise concerning office hysteroscopy than their Flemish colleagues. Future research on the cost-effectiveness of and optimisation of patient comfort during office hysteroscopy is needed to support its further implementation.

Clinical implementation of the hysteroscopic morcellator for removal of intrauterine myomas and polyps. A retrospective descriptive study.

The aim of this study is to report our experience with a novel technique, the hysteroscopic morcellator (HM), for removal of intrauterine myomas and polyps. We performed a retrospective study on 315 women undergoing operative hysteroscopy with the HM in our university-affiliated teaching hospital. We collected data on installation and operating times, fluid deficit, peri- and postoperative complications. In 37 patients undergoing myomectomy with the HM, mean installation time was 8.7 min, mean operating time, 18.2 min, and median fluid deficit, 440 mL. Three out of 37 HM procedures were converted to resectoscopy, related to a type 2 myoma. In 278 patients, mean installation and operating times for polypectomy with the HM were 7.3 min and 6.6 min, respectively. All procedures were uneventful. Implementation of the HM for removal of type 0 and 1 myomas ≤3 cm, and removal of polyps appears safe and effective. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s10397-010-0627-7) contains supplementary material, which is available to authorized users.

Hysteroscopic morcellator system can be used for removal of a uterine septum.

OBJECTIVE: To evaluate whether the hysteroscopic morcellator (HM) can be used as an alternative for uterine septum removal. DESIGN: Case report. SETTING: Outpatient clinic of a university-affiliated teaching hospital (Catharina Hospital, Eindhoven, the Netherlands). PATIENT(S): A 34-year-old Asian woman with recurrent miscarriages and a large uterine septum and bicornuate uterus. INTERVENTION(S): Septum removal using the HM. MAIN OUTCOME MEASURE(S): Successful removal of a uterine septum. RESULT(S): Considering obstetric complications, septum removal was carried out. Currently, septum transection using the resectoscope is the gold standard. Instead of transection we achieved nearly complete removal of a septum, using the HM. CONCLUSION(S): The HM is a safe, effective, and easily manageable alternative for uterine septum removal compared with classic resectoscopy.