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.

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.

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.

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.

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 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.