[TruClear™ treatment of caesarean scar pregnancy interrupted after methotrexate injection]. / Résection mécanique hystéroscopique de résidus trophoblastique d'une grossesse sur cicatrice de césarienne après injection de méthotrexate.

BACKGROUND: Cesarean scar pregnancy is a complicated and potentially life-threatening type of ectopic pregnancy. There is no gold standard for its management. The aim is to demonstrate the efficacy and safety of treatment by hysteroscopic tissue removal system after systemic methotrexate injection. METHODS: We report the case of a 27-year-old patient who had previously had a C-section and who presented herself to the emergency room with pelvic pain and metrorrhagia. The human chorionic gonadotrophin (hCG) serum level was positive. The exploration revealed an ectopic pregnancy on the cesarean scar. She benefited of 4 systemic injections of methotrexate. As the hCG became negative, endovaginal ultrasound confirmed the avascular nature of the mass. Surgical resection by mechanical morcellation hysteroscopy (TruClear™) was performed under general anaesthesia, visual control and ultrasound guidance. RESULTS: This procedure was successful. It was an ambulatory procedure and there were neither intra- nor postoperative complications. CONCLUSIONS: To our knowledge, this is the first time in Belgium that a hysteroscopic tissue removal system procedure has been used to treat a caesarean scar pregnancy. This technique seems to be safe for both the patient and the surgeon and could become a new approach for cesarean scar pregnancy management.

CONTEXTE: La grossesse sur cicatrice de césarienne est définie comme la présence d'un sac gestationnel dans une isthmocèle créée par une hystérotomie préalable. Il n'existe pas de gold standard concernant sa prise en charge. L'objectif est de démontrer l'efficacité et la sécurité du traitement par résection mécanique hystéroscopique des tissus après injection systémique de méthotrexate. Méthodes : Nous rapportons le cas d'une patiente de 27 ans ayant déjà eu une césarienne et qui s'est présentée aux urgences avec des douleurs pelviennes et des métrorragies. L'exploration révèle une grossesse sur la cicatrice de césarienne. Elle a bénéficié de 4 injections systémiques de méthotrexate. La résection des résidus trophoblastiques avasculaires a été réalisée par voie hystéroscopique en utilisant l'hystéroscope par action mécanique de type -TruClear™ et ce, sous contrôle échographique concomitant. Résultats : Cette procédure ambulatoire effectuée sous anesthésie générale a été un succès. Il n'y a eu aucune complication per- ou postopératoire. CONCLUSIONS: À notre connaissance, c'est la première fois qu'une résection par action mécanique des résidus trophoblastiques sur cicatrice de césarienne est réalisée en Belgique. Cette technique semble sûre pour la patiente et le chirurgien et pourrait devenir une nouvelle approche pour la prise en charge d'une grossesse sur cicatrice de césarienne.

Office intrauterine morcellation for retained products of conception.

OBJECTIVE: Proposing hysteroscopic morcellation (HM) as a surgical-therapeutic approach in the treatment of retained products of conception (RPOC) to prevent intrauterine adhesions (IUAs). DESIGN: Prospective analysis. SETTING: A teaching and university hospital. PATIENTS: Women with RPOC. INTERVENTIONS: Office -HM with 'Truclear 5 C'. MATERIAL AND METHODS: Twenty-two consecutive patients presenting with trophoblastic residue retention after miscarriage and interruption of pregnancy or placenta remnants after cesarean section or delivery were enrolled. These women underwent office-HM with 'Truclear 5 C'. Primary outcomes were median time and rate of hospitalization. The quality of the specimen was also analyzed. A hysteroscopic second look for IUAs was performed. RESULTS: Mean procedure time was six minutes (SD ± 5). Tissue samples had a mean collection size 2.5 cm3+0.9. 38% of the samples had spotting or abnormal vaginal discharge. Dilatation of the cervical canal was not performed in any case. Second-look hysteroscopy did not show any de novo IUAs in any of the enrolled patients. CONCLUSIONS: In the hysteroscopic treatment of RPOC, HM is a valid choice in an office setting without the use of cervical dilatation. Removal of RPOC was uneventful in all cases, simple and carried out faster without any adverse outcomes.

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.

Hysteroscopic morcellation: review of the manufacturer and user facility device experience (MAUDE) database.

STUDY OBJECTIVE: To investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease. DESIGN: Systematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III). SETTING N/A PATIENTS: Women undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator. INTERVENTIONS: The MAUDE database was searched for the key words "Hysteroscope," "Hysteroscopic reciprocating morcellator," "Interlace," "MyoSure," "Smith & Nephew," and "TRUCLEAR," to identify reported incidences of device malfunction, injury, or death. A total of 119 adverse events were analyzed. Reports were reviewed individually and categorized by date of occurrence, type of morcellation device, type of complication, and a brief description. Each company was contacted to provide an estimate of the number of procedures performed or units sold to date. MEASUREMENTS AND MAIN RESULTS: From 2005 to June 2014, 119 adverse events were reported to the MAUDE database. On the basis of severity, adverse events were categorized as major or minor complications. Major events included intubation/admission to an intensive care unit (n = 14), bowel damage (n = 12), hysterectomy (n = 6), and death (n = 2). Minor events included uterine perforation requiring no other treatment (n = 29), device failure (n = 25), uncomplicated fluid overload (n = 19), postoperative bleeding controlled using noninvasive measures (n = 6), and pelvic infection (n = 4). These events were then categorized according to manufacturer. The number of adverse events reported to the MAUDE database was divided by the total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicated hysteroscopic morcellation in <0.1% cases. CONCLUSIONS: The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur during traditional resectoscopy. On the basis of acknowledged limited information from the MAUDE database, it seems that life-threatening complications such as fluid overload, uterine perforation, and bleeding do occur with hysteroscopic morcellation but less frequently than with traditional electrocautery.

A comparison of hysteroscopic mechanical tissue removal with bipolar electrical resection for the management of endometrial polyps in an ambulatory care setting: preliminary results.

STUDY OBJECTIVE: To assess and compare efficacy, pain, and the learning curve associated with diagnostic therapeutic hysteroscopy using mechanical tissue removal versus bipolar electrical resection in the management of endometrial polyps in an ambulatory care setting. DESIGN: A randomized controlled clinical trial (Canadian Task Force classification I). SETTING: Hospital de Igulada, Barcelona, Spain. PATIENTS: A total of 133 patients diagnosed with endometrial polyp(s) were included and randomly assigned to 1 of the 2 hysteroscopic methods. Criteria assessed were total hysteroscopy time, full polypectomy procedure time, pain experienced by patients, and learning curve of staff in training. MEASUREMENTS AND MAIN RESULTS: The average time to perform total hysteroscopy using the mechanical tissue removal system (TRUCLEAR 5.0 System; Smith & Nephew Inc., Andover, MD) was 6 minutes 49 seconds versus 11 minutes 37 seconds required for the bipolar electrosurgery system (GYNECARE VERSAPOINT; Ethicon Inc, Somerville, NJ) (p < .01). Results for complete polypectomy time favored the TRUCLEAR System at 3 minutes 7 seconds over the VERSAPOINT System at 8 minutes 25 seconds (p < .01). If a successful procedure is predicated on access to cavity, visualization, and complete resection and excision of endometrial polyp, the mechanical TRUCLEAR Tissue Removal System shows a higher success rate than the VERSAPOINT Bipolar Electrosurgery System at 92% and 77%, respectively. Analysis of pain using the visual analog scale revealed no significant differences between the 2 techniques (p > .05). A study of the residents' learning curve showed a higher level of autonomy with hysteroscopy using the TRUCLEAR Tissue Removal System with which residents showed a higher level of confidence compared with hysteroscopy with the VERSAPOINT Bipolar Electrosurgery System. CONCLUSION: In hysteroscopic polypectomy, the mechanical tissue removal system was significantly faster, achieved a greater success rate for complete polypectomy, and required a shorter learning curve from staff being trained in the management of endometrial polyps when compared with bipolar electrical resection.

Hysteroscopic tissue removal systems for the treatment of intrauterine pathology: a systematic review and meta-analysis.

BACKGROUND: The use of mechanical tissue removal systems is more frequently implemented as the first line approach for the treatment of intrauterine pathology. Scientific evidence is provided that their use is easier and faster than the conventional resectoscope. It is necessary to objectively evaluate the results on tissue removal systems for the treatment of endometrial pathology as the reports in the literature are still conflicting. OBJECTIVE: To review and compare mechanical hysteroscopic tissue removal systems (Truclear®, Myosure® or IBS®) versus conventional bipolar and monopolar resectoscopy for the treatment of polyp and myoma removal. Operation time, completeness of tissue removal, complication rate, fluid deficit, tolerability and learning curve were evaluated. METHODS: Electronic databases PubMed; Medline and Web of Science were searched for papers published from 1st January 2010 to 1st May 2019 using terms: ("hysteroscopic" or "hysteroscopy" or "hysteroscopic surgery") and ("myoma" or "polyps"). Studies were included if they were retrospective, observational and prospective randomized clinical controlled trials if they investigated the techniques between the tissue removal systems (Truclear®, Myosure® or IBS®) and conventional resectoscopy for the treatment of intrauterine pathology. Data were extracted from the included studies by two independent reviewers. Meta-analysis was performed by Rev Man 5 software (Cochrane Collaboration, London, UK). Results: Overall, 498 patients were analysed from five studies in which there was no difference in age and size of pathology treated either by the hysteroscopic tissue removal systems and the conventional resectoscope. Hysteroscopic tissue removal systems showed a significantly higher success rate of complete endometrial pathology removal (P=0.002) and a significantly shorter operation time for polyp removal (P<0.0001) compared to conventional resectoscopy. No significant differences, in terms of complications rate, were found (P=0.09). The fluid deficit was significantly higher in the tissue removal system group, compared to conventional resectoscopy (P=0.02). CONCLUSION: Hysteroscopic tissue removal systems showed a major advantage in successful removal of the pathology and total operation time. It is likely that the tissue removal systems are more accessible and have a lower complication profile including perforation, via falsa and bleeding due to its specific action mechanism and shorter operation time but higher-quality trials will be required to confirm this hypothesis.