Septum resection versus expectant management in women with a septate uterus: an international multicentre open-label randomized controlled trial.

STUDY QUESTION: Does septum resection improve reproductive outcomes in women with a septate uterus? SUMMARY ANSWER: Hysteroscopic septum resection does not improve reproductive outcomes in women with a septate uterus. WHAT IS KNOWN ALREADY: A septate uterus is a congenital uterine anomaly. Women with a septate uterus are at increased risk of subfertility, pregnancy loss and preterm birth. Hysteroscopic resection of a septum may improve the chance of a live birth in affected women, but this has never been evaluated in randomized clinical trials. We assessed whether septum resection improves reproductive outcomes in women with a septate uterus, wanting to become pregnant. STUDY DESIGN, SIZE, DURATION: We performed an international, multicentre, open-label, randomized controlled trial in 10 centres in The Netherlands, UK, USA and Iran between October 2010 and September 2018. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women with a septate uterus and a history of subfertility, pregnancy loss or preterm birth were randomly allocated to septum resection or expectant management. The primary outcome was conception leading to live birth within 12 months after randomization, defined as the birth of a living foetus beyond 24 weeks of gestational age. We analysed the data on an intention-to-treat basis and calculated relative risks with 95% CI. MAIN RESULTS AND THE ROLE OF CHANCE: We randomly assigned 80 women with a septate uterus to septum resection (n = 40) or expectant management (n = 40). We excluded one woman who underwent septum resection from the intention-to-treat analysis, because she withdrew informed consent for the study shortly after randomization. Live birth occurred in 12 of 39 women allocated to septum resection (31%) and in 14 of 40 women allocated to expectant management (35%) (relative risk (RR) 0.88 (95% CI 0.47 to 1.65)). There was one uterine perforation which occurred during surgery (1/39 = 2.6%). LIMITATIONS, REASONS FOR CAUTION: Although this was a major international trial, the sample size was still limited and recruitment took a long period. Since surgical techniques did not fundamentally change over time, we consider the latter of limited clinical significance. WIDER IMPLICATIONS OF THE FINDINGS: The trial generated high-level evidence in addition to evidence from a recently published large cohort study. Both studies unequivocally do not reveal any improvements in reproductive outcomes, thereby questioning any rationale behind surgery. STUDY FUNDING/COMPETING INTEREST(S): There was no study funding. M.H.E. reports a patent on a surgical endoscopic cutting device and process for the removal of tissue from a body cavity licensed to Medtronic, outside the scope of the submitted work. H.A.v.V. reports personal fees from Medtronic, outside the submitted work. B.W.J.M. reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck Merck KGaA, personal fees from Guerbet, personal fees from iGenomix, outside the submitted work. M.G. reports several research and educational grants from Guerbet, Merck and Ferring (location VUMC) outside the scope of the submitted work. The remaining authors have nothing to declare. TRIAL REGISTRATION NUMBER: Dutch trial registry: NTR 1676. TRIAL REGISTRATION DATE: 18 February 2009. DATE OF FIRST PATIENT'S ENROLMENT: 20 October 2010.

Septum resection in women with a septate uterus: a cohort study.

STUDY QUESTION: Does septum resection improve reproductive outcomes in women with a septate uterus? SUMMARY ANSWER: In women with a septate uterus, septum resection does not increase live birth rate nor does it decrease the rates of pregnancy loss or preterm birth, compared with expectant management. WHAT IS KNOWN ALREADY: The septate uterus is the most common uterine anomaly with an estimated prevalence of 0.2-2.3% in women of reproductive age, depending on the classification system. The definition of the septate uterus has been a long-lasting and ongoing subject of debate, and currently two classification systems are used worldwide. Women with a septate uterus may be at increased risk of subfertility, pregnancy loss, preterm birth and foetal malpresentation. Based on low quality evidence, current guidelines recommend removal of the intrauterine septum or, more cautiously, state that the procedure should be evaluated in future studies. STUDY DESIGN, SIZE, DURATION: We performed an international multicentre cohort study in which we identified women mainly retrospectively by searching in electronic patient files, medical records and databases within the time frame of January 2000 until August 2018. Searching of the databases, files and records took place between January 2016 and July 2018. By doing so, we collected data on 257 women with a septate uterus in 21 centres in the Netherlands, USA and UK. PARTICIPANTS/MATERIALS, SETTING, METHODS: We included women with a septate uterus, defined by the treating physician, according to the classification system at that time. The women were ascertained among those with a history of subfertility, pregnancy loss, preterm birth or foetal malpresentation or during a routine diagnostic procedure. Allocation to septum resection or expectant management was dependent on the reproductive history and severity of the disease. We excluded women who did not have a wish to conceive at time of diagnosis. The primary outcome was live birth. Secondary outcomes included pregnancy loss, preterm birth and foetal malpresentation. All conceptions during follow-up were registered but for the comparative analyses, only the first live birth or ongoing pregnancy was included. To evaluate differences in live birth and ongoing pregnancy, we used Cox proportional regression to calculate hazard rates (HRs) and 95% CI. To evaluate differences in pregnancy loss, preterm birth and foetal malpresentation, we used logistic regression to calculate odds ratios (OR) with corresponding 95% CI. We adjusted all reproductive outcomes for possible confounders. MAIN RESULTS AND THE ROLE OF CHANCE: In total, 257 women were included in the cohort. Of these, 151 women underwent a septum resection and 106 women had expectant management. The median follow-up time was 46 months. During this time, live birth occurred in 80 women following a septum resection (53.0%) compared to 76 women following expectant management (71.7%) (HR 0.71 95% CI 0.49-1.02) and ongoing pregnancy occurred in 89 women who underwent septum resection (58.9%), compared to 80 women who had expectant management (75.5%) (HR 0.74 (95% CI 0.52-1.06)). Pregnancy loss occurred in 51 women who underwent septum resection (46.8%) versus 31 women who had expectant management (34.4%) (OR 1.58 (0.81-3.09)), while preterm birth occurred in 26 women who underwent septum resection (29.2%) versus 13 women who had expectant management (16.7%) (OR 1.26 (95% CI 0.52-3.04)) and foetal malpresentation occurred in 17 women who underwent septum resection (19.1%) versus 27 women who had expectant management (34.6%) (OR 0.56 (95% CI 0.24-1.33)). LIMITATIONS, REASONS FOR CAUTION: Our retrospective study has a less robust design compared with a randomized controlled trial. Over the years, the ideas about the definition of the septate uterus has changed, but since the 257 women with a septate uterus included in this study had been diagnosed by their treating physician according to the leading classification system at that time, the data of this study reflect the daily practice of recent decades. Despite correcting for the most relevant patient characteristics, our estimates might not be free of residual confounding. WIDER IMPLICATIONS OF THE FINDINGS: Our results suggest that septum resection, a procedure that is widely offered and associated with financial costs for society, healthcare systems or individuals, does not lead to improved reproductive outcomes compared to expectant management for women with a septate uterus. The results of this study need to be confirmed in randomized clinical trials. STUDY FUNDING/COMPETING INTEREST(S): A travel for JFWR to Chicago was supported by the Jo Kolk Studyfund. Otherwise, no specific funding was received for this study. The Department of Obstetrics and Gynaecology, University Medical Centre, Groningen, received an unrestricted educational grant from Ferring Pharmaceutical Company unrelated to the present study. BWM reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck, personal fees from Guerbet, other payment from Guerbet and grants from Merck, outside the submitted work. The other authors declare no conficts of interest. TRIAL REGISTRATION NUMBER: N/A.

Immediate versus delayed removal of urinary catheter after laparoscopic hysterectomy: a randomised controlled trial.

OBJECTIVE: To evaluate if immediate catheter removal (ICR) after laparoscopic hysterectomy is associated with similar retention outcomes compared with delayed removal (DCR). STUDY DESIGN: Non-inferiority randomised controlled trial. POPULATION: Women undergoing laparoscopic hysterectomy in six hospitals in the Netherlands. METHODS: Women were randomised to ICR or DCR (between 18 and 24 hours after surgery). PRIMARY OUTCOME: The inability to void within 6 hours after catheter removal. RESULTS: One hundred and fifty-five women were randomised to ICR (n = 74) and DCR (n = 81). The intention-to-treat and per-protocol analysis could not demonstrate the non-inferiority of ICR: ten women with ICR could not urinate spontaneously within 6 hours compared with none in the delayed group (risk difference 13.5%, 5.6-24.8, P = 0.88). However, seven of these women could void spontaneously within 9 hours without additional intervention. Regarding the secondary outcomes, eight women from the delayed group requested earlier catheter removal because of complaints (9.9%). Three women with ICR (4.1%) had a urinary tract infection postoperatively versus eight with DCR (9.9%, risk difference -5.8%, -15.1 to 3.5, P = 0.215). Women with ICR mobilised significantly earlier (5.7 hours, 0.8-23.3 versus 21.0 hours, 1.4-29.9; P ≤ 0.001). CONCLUSION: The non-inferiority of ICR could not be demonstrated in terms of urinary retention 6 hours after procedure. However, 70% of the women with voiding difficulties could void spontaneously within 9 hours after laparoscopic hysterectomy. It is therefore questionable if all observed urinary retention cases were clinically relevant. As a result, the clinical advantages of ICR may still outweigh the risk of bladder retention and it should therefore be considered after uncomplicated laparoscopic hysterectomy. TWEETABLE ABSTRACT: The advantages of immediate catheter removal after laparoscopic hysterectomy seem to outweigh the risk of bladder retention.

Surgical phase modelling in minimal invasive surgery.

BACKGROUND: Surgical Process Modelling (SPM) offers the possibility to automatically gain insight in the surgical workflow, with the potential to improve OR logistics and surgical care. Most studies have focussed on phase recognition modelling of the laparoscopic cholecystectomy, because of its standard and frequent execution. To demonstrate the broad applicability of SPM, more diverse and complex procedures need to be studied. The aim of this study is to investigate the accuracy in which we can recognise and extract surgical phases in laparoscopic hysterectomies (LHs) with inherent variability in procedure time. To show the applicability of the approach, the model was used to automatically predict surgical end-times. METHODS: A dataset of 40 video-recorded LHs was manually annotated for instrument use and divided into ten surgical phases. The use of instruments provided the feature input for building a Random Forest surgical phase recognition model that was trained to automatically recognise surgical phases. Tenfold cross-validation was performed to optimise the model for predicting the surgical end-time throughout the procedure. RESULTS: Average surgery time is 128 ± 27 min. Large variability within specific phases is seen. Overall, the Random Forest model reaches an accuracy of 77% recognising the current phase in the procedure. Six of the phases are predicted accurately over 80% of their duration. When predicting the surgical end-time, on average an error of 16 ± 13 min is reached throughout the procedure. CONCLUSIONS: This study demonstrates an intra-operative approach to recognise surgical phases in 40 laparoscopic hysterectomy cases based on instrument usage data. The model is capable of automatic detection of surgical phases for generation of a solid prediction of the surgical end-time.

The randomised uterine septum transsection trial (TRUST): design and protocol.

BACKGROUND: A septate uterus is a uterine anomaly that may affect reproductive outcome, and is associated with an increased risk for miscarriage, subfertility and preterm birth. Resection of the septum is subject of debate. There is no convincing evidence concerning its effectiveness and safety. This study aims to assess whether hysteroscopic septum resection improves reproductive outcome in women with a septate uterus. METHODS/DESIGN: A multi-centre randomised controlled trial comparing hysteroscopic septum resection and expectant management in women with recurrent miscarriage or subfertility and diagnosed with a septate uterus. The primary outcome is live birth, defined as the birth of a living foetus beyond 24 weeks of gestational age. Secondary outcomes are ongoing pregnancy, clinical pregnancy, miscarriage and complications following hysteroscopic septum resection. The analysis will be performed according to the intention to treat principle. Kaplan-Meier curves will be constructed, estimating the cumulative probability of conception leading to live birth rate over time. Based on retrospective studies, we anticipate an improvement of the live birth rate from 35% without surgery to 70% with surgery. To demonstrate this difference, 68 women need to be randomised. DISCUSSION: Hysteroscopic septum resection is worldwide considered as a standard procedure in women with a septate uterus. Solid evidence for this recommendation is lacking and data from randomised trials is urgently needed. TRIAL REGISTRATION: Dutch trial registry ( NTR1676 , 18th of February 2009).

Spontaneous haemoperitoneum in pregnancy and endometriosis: a case series.

OBJECTIVE: To report pregnancy outcomes of SHiP (spontaneous haemoperitoneum in pregnancy) and the association with endometriosis. DESIGN: Retrospective case note review. SETTING: Dutch referral hospitals for endometriosis. SAMPLE: Eleven women presenting with 15 events of SHiP. METHODS: In collaboration with the Dutch Working Group on Endometriosis, unpublished cases of SHiP that occurred in the Netherlands between 2010 and 2015 were retrieved. MAIN OUTCOME MEASURES: Maternal and perinatal mortality and morbidity. RESULTS: SHiP occurred predominantly in the second and third trimester of pregnancy. The earliest and major presenting symptom was an acute onset of abdominal pain, often combined with low haemoglobin levels or signs of fetal distress. Imaging was a diagnostic tool when free peritoneal fluid could be observed. For surgical treatment of the bleeding site, a midline laparotomy was mostly needed, the median estimated amount of blood loss was 2000 mL. No fetomaternal or perinatal mortality was reported, despite a high rate of preterm births (54.5%). In all women, endometriosis was diagnosed at a certain moment in time and therefore was probably involved in the pathogenesis of SHiP. Four women showed recurrence of SHiP. In one of these cases the second event of SHiP occurred in a subsequent pregnancy. CONCLUSION: Pregnancy outcomes of SHiP are improving when compared with previous reports, with absent fetomaternal and perinatal mortality in this recent series. Growing knowledge and adequate multidisciplinary intervention may have contributed to these favourable results. Increasing awareness of this serious complication of pregnancy is advocated, especially in women diagnosed with endometriosis. TWEETABLE ABSTRACT: Growing awareness of SHiP is advocated, especially in women diagnosed with endometriosis.

Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342).

BACKGROUND: Success rates of assisted reproductive techniques (ART) are approximately 30%, with the most important limiting factor being embryo implantation. Mechanical endometrial injury, also called 'scratching', has been proposed to positively affect the chance of implantation after embryo transfer, but the currently available evidence is not yet conclusive. The primary aim of this study is to determine the effect of endometrial scratching prior to a second fresh in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycle on live birth rates in women with a failed first IVF/ICSI cycle. METHOD: Multicenter randomized controlled trial in Dutch academic and non-academic hospitals. A total of 900 women will be included of whom half will undergo an endometrial scratch in the luteal phase of the cycle prior to controlled ovarian hyperstimulation using an endometrial biopsy catheter. The primary endpoint is the live birth rate after the 2nd fresh IVF/ICSI cycle. Secondary endpoints are costs, cumulative live birth rate (after the full 2nd IVF/ICSI cycle and over 12 months of follow-up); clinical and ongoing pregnancy rate; multiple pregnancy rate; miscarriage rate and endometrial tissue parameters associated with implantation failure. DISCUSSION: Multiple studies have been performed to investigate the effect of endometrial scratching on live birth rates in women undergoing IVF/ICSI cycles. Due to heterogeneity in both the method and population being scratched, it remains unclear which group of women will benefit from the procedure. The SCRaTCH trial proposed here aims to investigate the effect of endometrial scratching prior to controlled ovarian hyperstimulation in a large group of women undergoing a second IVF/ICSI cycle. TRIAL REGISTRATION: NTR 5342 , registered July 31st, 2015. PROTOCOL VERSION: Version 4.10, January 4th, 2017.

Disseminated leiomyoma cells can be identified following conventional myomectomy.

OBJECTIVE: Uncontained morcellation of leiomyomas during laparoscopic surgery has recently been discouraged, as undetected malignant tumours, namely leiomyosarcomas, could be fragmented which may result in upstaged disease. However, enucleating leiomyomas per se may be inappropriate from an oncological perspective because complete, radical resection of malignant tumours to prevent further tumour growth or recurrence is not achieved. Thus, the aim of this study was to determine whether spillage of leiomyoma cells occurs during laparotomic myomectomy. DESIGN: Observational study. SETTING: Tertiary academic centre in the Netherlands. POPULATION: Women undergoing laparotomic myomectomy were included in the study. METHODS: Peritoneal abdominal washings were obtained on two occasions during the myomectomy procedure; the first one immediately after opening the abdomen and the second one after resection of the leiomyoma(s). Cytological evaluation of the fluids was performed. MAIN OUTCOME MEASURES: The presence of leiomyoma cells in any of the washings. RESULTS: Five patients were included in this pilot study. All first washings were negative for leiomyoma cells. However, cytology positive for the presence of leiomyoma cells was found in three of the five second, post-myomectomy washings. CONCLUSION: Tissue spillage from leiomyoma(s) occurs during conventional open myomectomy. The clinical relevance of tissue dissemination after myomectomy is unclear but it cannot be excluded that this may negatively affect the patient's outcome if there is malignant change within the enucleated leiomyoma(s). Therefore, it is questionable whether morcellation in specially designed containment bags after laparoscopic myomectomy, guarantees any additional oncological safety. TWEETABLE ABSTRACT: Even during conventional myomectomy, tissue spillage occurs during resection of leiomyoma(s).

Laparoscopic suturing learning curve in an open versus closed box trainer.

BACKGROUND: The aim of this study was to examine the influence of training under direct vision prior to training with indirect vision on the learning curve of the laparoscopic suture task. METHODS: Novices were randomized in two groups. Group 1 performed three suturing tasks in a transparent laparoscopic box trainer under direct vision followed by three suturing tasks in a standard non-transparent laparoscopic box trainer equipped with a 0° laparoscope. Group 2 performed six suturing tasks in a standard laparoscopic box trainer. Performance time, motion analysis parameters (economy of movements) and interaction force parameters (tissue handling) were measured. Participants completed a questionnaire assessing: self-perceived dexterity before and after the training, their experienced frustration and the difficulty of the training. RESULTS: A total of 34 participants were included, one was excluded because of incomplete training. Group 1 used significantly less time to complete the total of six tasks (27 %). At the end of the training, there were no differences in motion or force parameters between the two groups. Group 2 rated their self-perceived dexterity after the training significantly lower than before the training and also reported significantly higher levels of frustration compared to group 1. Both groups rated the difficulty of the training similar. CONCLUSION: Novices benefit from starting their training of difficult basic laparoscopic skills, e.g., suturing, in a transparent box trainer without camera. It takes less time to complete the tasks, and they get less frustrated by the training with the same results on their economy of movements and tissue handling skills.

Tying different knots: what forces do we use?

BACKGROUND: A study was performed to determine differences in applied interaction force between conventional open surgery and laparoscopic surgery during suturing in a non-clinical setting. METHODS: In a laparoscopic box trainer set-up, experts performed two intracorporeal and two extracorporeal sutures on an artificial skin model. They also performed two instrument-tie knots and two one-hand square knots in a similar conventional training set-up. The force exerted on the artificial tissue (mean force, mean non-zero, maximum, and volume) and the time to complete a task were measured. For analysis purposes, sutures are divided in a needle driving phase (Phase 1) and knot-tying phase (Phase 2). RESULTS: Phase 1: Force values in laparoscopic suturing are significantly higher than in conventional suturing, except for the force volume during extracorporeal suturing versus the one-hand square knot. Phase 2: The mean force non-zero and maximum force during the intracorporeal knot are significantly higher than during the instrument-tie knot. The mean and maximum force during the extracorporeal knot are significantly higher than during the one-hand square knot. Furthermore, laparoscopic suturing takes longer time than conventional suturing. CONCLUSION: Expert surgeons apply significantly higher force during laparoscopic surgery compared to conventional surgery even though the same strategy is used. Aspects such as the limited visual and haptic feedback, and movement possibilities hamper surgeons' ability to assess the applied interaction force. Therefore it can be useful to provide additional force feedback about the applied interaction force during training in non-clinical settings.

Efficacy and safety of uterine manipulators in laparoscopic surgery: a review.

PURPOSE: This review aims to objectively assess the efficacy and safety of uterine manipulators as reported in scientific literature. Furthermore, it evaluates as to which manipulator best suits which surgical procedure. METHODS: PubMed, Embase, Web of Science, COCHRANE, CINAHL, Academic Search Premier, Science Direct and the MAUDE database were searched. Technical information was retrieved from the manufacturers. RESULTS: 25 articles covering 10 uterine manipulators were found. Studies regarding implementation and use of manipulators are scarce; only two surveys were found comparing different manipulators. Moreover, clinical evidence proving the efficacy of manipulators with respect to prevention of complications, inherent to laparoscopic surgery, does not exist. CONCLUSION: The use of uterine manipulators is well established and it is clear that uterine manipulators offer the easiest way to handle the uterus during surgery. However, detailed information regarding efficacy and safety is scarce. Clinical evidence substantiating the assumed mechanism of prevention of ureter injuries was not found. Our review did not find the optimal manipulator. Some are more versatile than others and not all instruments are appropriate for all types of surgery. Therefore, gynecologists should choose the manipulator that best suits the type of surgery that is performed.

Influence of visual force feedback on tissue handling in minimally invasive surgery.

BACKGROUND: Force feedback might improve surgical performance during minimally invasive surgery. This study sought to determine whether training with force feedback shortened the tissue-handling learning curve, and examined the influence of real-time visual feedback compared with postprocessing feedback. METHODS: Medical students without experience of minimally invasive surgery were randomized into three groups: real-time force feedback, postprocessing force feedback and no force feedback (control). All performed eight suturing tasks consecutively, of which the first and eighth were the premeasurement and postmeasurement tasks respectively (no feedback). Depending on randomization, either form of feedback was given during the second to seventh task. Time, mean force non-zero and maximum force were measured with a force sensor. Results of the groups were compared with one-way ANOVA, and intragroup improvement using a paired-samples t test. RESULTS: A total of 72 students took part. Both intervention groups used significantly lower interaction forces than the control group during the knot-tying phase of the postmeasurement task and improved their interaction forces significantly during the knot-tying phase. The form of feedback did not influence its effectiveness. CONCLUSION: The tissue-handling skills of medical students improved significantly when they were given force feedback of their performance. This effect was seen mainly during the knot-tying phase of the suturing task.

Intracorporeal knot tying in a box trainer: how proficient is in vitro evaluation in laparoscopic experts?

OBJECTIVE: To determine the applicability of motion analysis parameters of intracorporeal knot tying in box trainers in experts as predictors of surgical outcome. DESIGN: Consecutive series of 1534 advanced laparoscopic hysterectomies (Canadian Task Force classification II-2). INTERVENTION: Time, path length, and motion in depth of a standardized intracorporeal knot-tying task were compared with mean risk-adjusted primary clinical outcomes for each participant. RESULTS: Although a large variety in proficient knot tying and surgical skills factors was observed; after correction for patient mix in 50 expert surgeons, motion analysis of intracorporeal knot tying could not significantly determine surgical outcome skills in advanced laparoscopic surgery. CONCLUSION: Levels of proficiency in advanced laparoscopic surgery cannot be appropriately determined using motion analysis in box trainers. Therefore, box trainer assessments do not adequately differentiate proficient from suboptimal clinical performance.

Effect of unidirectional airflow ventilation on surgical site infection in cardiac surgery: environmental impact as a factor in the choice for turbulent mixed air flow.

BACKGROUND: Surgical site infection (SSI) in the form of postoperative deep sternal wound infection (DSWI) after cardiac surgery is a rare, but potentially fatal, complication. In addressing this, the focus is on preventive measures, as most risk factors for SSI are not controllable. Therefore, operating rooms are equipped with heating, ventilation and air conditioning (HVAC) systems to prevent airborne contamination of the wound, either through turbulent mixed air flow (TMA) or unidirectional air flow (UDAF). AIM: To investigate if the risk for SSI after cardiac surgery was decreased after changing from TMA to UDAF. METHODS: This observational retrospective single-centre cohort study collected data from 1288 patients who underwent open heart surgery over 2 years. During the two study periods, institutional SSI preventive measures remained the same, with the exception of the type of HVAC system that was used. FINDINGS: Using multi-variable logistic regression analysis that considered confounding factors (diabetes, obesity, duration of surgery, and re-operation), the hypothesis that TMA is an independent risk factor for SSI was rejected (odds ratio 0.9, 95% confidence interval 0.4-1.8; P>0.05). It was not possible to demonstrate the preventive effect of UDAF on the incidence of SSI in patients undergoing open heart surgery when compared with TMA. CONCLUSION: Based on these results, the use of UDAF in open heart surgery should be weighed against its low cost-effectiveness and negative environmental impact due to high electricity consumption. Reducing energy overuse by utilizing TMA for cardiac surgery can diminish the carbon footprint of operating rooms, and their contribution to climate-related health hazards.

Energetic soft-tissue treatment technologies: an overview of procedural fundamentals and safety factors.

BACKGROUND: Energy administered during soft-tissue treatments may cauterize, coagulate, seal, or otherwise affect underlying structures. A general overview of the functionality, procedural outcomes, and associated risks of these treatments, however, is not yet generally available. In addition, literature is sometimes inconsistent with regards to terminology. Along with the rapid expansion of available energetic instruments, particularly in the field of endoscopic surgery, these factors may complicate the ability to step back, review available treatment options, and identify critical parameters for appropriate use. METHODS: Online databases of PubMed, Web of Science, and Google Scholar were used to collect literature on popular energetic treatments, such as electrosurgery, plasma surgery, ultrasonic surgery, and laser surgery. The main results include review and comparison studies on the working mechanisms, pathological outcomes, and procedural hazards. RESULTS: The tissue response to energetic treatments can be largely explained by known mechanical and thermal interactions. Application parameters, such as the interaction time and power density, were found to be of major influence. By breaking down treatments to this interaction level, it is possible to differentiate the available options and reveal their strengths and weaknesses. Exact measures of damage and alike quantifications of interaction are, although valuable to the surgeon, often either simply unknown due to the high impact of tissue and application-dependent parameters or badly documented in previous studies. In addition, inconsistencies in literature regarding the terminology of used techniques were observed and discussed. They may complicate the formulation of cause and effect relations and lead to misconceptions regarding the treatment performance. CONCLUSIONS: Some basic knowledge on used energetic treatments and settings and a proper use of terminology may enhance the practitioner's insight in allowable actions to take, improve the interpretation and diagnosis of histological and mechanical tissue changes, and decrease the probability of iatrogenic mishaps.

Efficiency based updating of evidence based surgical guidelines - Experiences from a multidisciplinary guideline upon Minimally Invasive Surgery.

Background: Updating evidence-based clinical practice guidelines is an onerous process and there is a call for more efficient determination of key questions that need updating. Especially for surgical techniques it is unclear if new evidence will result in substantial changes after wide implementation and if continuous updating is always necessary. Objectives: This study analyses the impact of updating a surgical guideline and proposes suggestions for optimising this process. Materials and methods: The Dutch Minimally Invasive Surgery guideline was developed in 2011 and updated in 2021. For both versions a multidisciplinary guideline working group (GDG) was created, that determined key questions. Changes in conclusions and recommendations were analysed by the GDG and statements for expected change of recommendations in the future were made. Results: 15 key questions were formed, of which 12 were updates of the previous guideline. For only 27% of the updated key questions, the conclusions changed. In ten years, the body grew only marginally for most key questions and quality of the evidence did not improve substantially for almost all key questions. However, in this first update of the MIC guideline, many recommendations did change due to a more robust interpretation of the conclusions by the GDG. Based on analysis of this updating process, the GDG expects that only four out of 15 recommendations may change in the future. Conclusion: We propose an additional step at the end of guideline development and updating, where the necessity for updating in the future is determined for each key question by the GDG, using their valuable knowledge gained from developing or updating the guideline. For surgical guidelines, the authors suggest updating key issues if it includes a relatively newly introduced surgical- or adapted technique or a new patient group. Low quality or small body of evidence should not be a reason in itself for updating, as this mostly does not lead to new evidence-based conclusions. This new step is expected to result in a more efficient prioritising of key questions that need updating. What's new?: By adding one additional step at the end of the updating process, the future updating process could become more efficient.

Preoperative pain measurements in correlation to deep endometriosis classification with Enzian

Background: Deep Endometriosis (DE) classification studies with Enzian never compared solitary compartments (A, B, C, F), and combinations of anatomical locations (A&B, A&C, B&C, A&B&C), in correlation to pain. Therefore, the results of these studies are challenging to translate to the clinical situation. Objectives: We studied pain symptoms and their correlation with the solitary and combinations of anatomical locations of deep endometriosis lesion(s) classified by the Enzian score. Materials and Methods: A prospective multi-centre study was conducted with data from university and non-university hospitals. A total of 419 surgical DE cases were collected with the web-based application called EQUSUM (www.equsum.org). Main Outcome Measures: Preoperative reported numeric rating scale (NRS) were collected along with the Enzian classification. Baseline characteristics, pain scores, surgical procedure and extent of the disease were also collected. Results: In general, more extensive involvement of DE does not lead to an increase in the numerical rating scale for pain measures. However, dysuria and bladder involvement do show a clear correlation AUC 0.62 (SE 0.04, CI 0.54-0.71, p< 0.01). Regarding the predictive value of dyschezia, we found a weak, but significant correlation with ureteric involvement; AUC 0.60 (SE 0.04, CI 0.53-0.67, p< 0.01). Conclusions: Pain symptoms poorly correlate with anatomical locations of deep endometriosis in almost all pain scores, with the exception of bladder involvement and dysuria which did show a correlation. Also, dyschezia seems to have predictive value for DE ureteric involvement and therefore MRI or ultrasound imaging (ureter and kidney) could be recommended in the preoperative workup of these patients. What's new?: Dyschezia might have a predictive value in detecting ureteric involvement.

Conservatively treated borderline ovarian tumours, followed by IVF treatment: a case series.

Borderline ovarian tumours (BOT) often affect young females, in whom conservative treatment may be desired in order to preserve fertility. It is unknown whether in vitro fertilisation (IVF) increases the risk of recurrent disease. This case-series will focus on four patients diagnosed with BOT, who were initially treated conservatively and subsequently received IVF. Five recurrences occurred prior to IVF and three recurrences occurred after IVF in three individuals. After a mean follow-up of 104 months after initial conservative treatment and 43 months after IVF treatment, all four patients were alive and disease-free.