In Vitro User Assessment of a Novel Wound Protection and Specimen Extraction System for Laparoscopic Procedures Involving Morcellation.

INTRODUCTION: The risk of unknowingly disseminating leiomyosarcoma by morcellation in women undergoing laparoscopic hysterectomy has massively impacted gynaecological practice. Here, we present the results of an in vitro assessment of a novel protection system developed to mitigate this hazard. METHODS: The Tissue Containment System for Manual Morcellation (Guardenia™, Advanced Surgical Concepts, Wicklow, Ireland) is an evolved wound protection/specimen extraction guarded bag system compatible with any 12mm trocar. Device use was assessed by device-naïve gynaecological and general surgeon volunteers (providing expert and inexpert morcellation cohorts, respectively) on a bench model consisting of biological tissue in a custom-built moulded rig with camera control after the operators were instructed in its use. RESULTS: Twenty surgeons (10 gynaecologists/10 general surgeons, median duration of practice experience: 8 years, median annual number of laparoscopic operative procedures: 150 and 80, respectively) completed the user assessment. All subjects understood and correctly performed each step; i.e., (i) placement of the bag through the trocar, (ii) specimen bagging, (iii) incision extension (range 25-60 mm) after tethering the bag through the port, (iv) insertion of the device guard through the mouth of the bag after trocar removal, and (v) sufficient tissue morcellation within the bag to enable complete specimen removal (mean specimen weight 390g, range 201-1800g). There was 100% bag integrity by water-leak testing following use, despite scalpel contact with the guard in 14/20 cases (70%). CONCLUSION: Among first-time clinical users, this novel device enabled complete containment of morcellation debris and removal of a laparoscopic specimen, which would support further submission for regulatory approval.

Tocolysis compared with no tocolysis in women with threatened preterm birth and ruptured membranes: A propensity score analysis.

INTRODUCTION: In women with preterm ruptured membranes and contractions, the administration of tocolysis is controversial. This study compares tocolysis with no tocolysis in women with threatened preterm birth and ruptured membranes. OBJECTIVE: To compare tocolysis with no tocolysis in women with threatened preterm birth and ruptured membranes. STUDY DESIGN: Data from the APOSTEL III RCT was combined with data from the National Maternity Hospital, Dublin. In the APOSTEL III trial, women with threatened preterm birth were randomized to atosiban or nifedipine. Patient data from Ireland were obtained from a cohort of women with threatened preterm birth with ruptured membranes. The Irish women received no tocolytic treatment. Only women with ruptured membranes and contractions were selected. We studied women with singleton or twin pregnancies and a gestational age between 25+0 and 33+6 weeks. Propensity score matching was performed to create comparable groups. Primary outcome was a composite adverse neonatal outcome. Secondary outcomes were individual components of the primary outcome, as well as neonatal intensive care unit (NICU) admission, gestational age at delivery, prolongation of pregnancy and mode of delivery. RESULTS: 153 women from the Apostel III trial were compared with 51 eligible women of the Irish cohort. We could match 46 women who received tocolysis and 46 women who received no tocolysis. All women had ruptured membranes. Maternal age, BMI, parity and gestational age at study entry were comparable between the groups after matching. There were no statistically significant differences in neonatal composite outcome (9.6 % in the tocolysis group versus 18 % in the control group, OR 0.46, 95 % CI 0.13-1.63). We found a lower incidence of NICU admission in the tocolysis group (63 %) than in the control group (94 %; OR 0.11, 95 % CI 0.03-0.41), which could be explained by differences in national admission policies. There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery. CONCLUSION: In this propensity score analysis of women with threatened preterm birth and ruptured membranes, tocolytic therapy did not alter composite adverse neonatal outcome or time to delivery.