Long-Term Follow-Up Regarding Pain Relief, Fertility, and Re-Operation after Surgery for Deep Endometriosis.

Background: Endometriosis is known to be a common chronic disease that often affects the quality of life of patients. Especially for deep endometriosis (DE), the most challenging form of the disease, surgery remains an important component of treatment. However, long-term outcomes after surgery are poorly studied. Therefore, we aimed to evaluate the postoperative clinical course of women with DE who underwent surgery, particularly with regard to pain relief, fertility, and re-operations. Methods: Thus, women who underwent surgical treatment for DE between 2005 and 2015 were included in this retrospective questionnaire-based analysis. Results: A total of 87.0% of the patients who underwent surgery for pain reported a postoperative relief of their complaints. Moreover, 44.6% even stated that they were free of pain at the time of the questionnaire. Patients who underwent surgery for infertility and tried to become pregnant postoperatively gave birth to a child in 45.9% of cases. Approximately one-third of the patients had to undergo another surgery because of endometriosis-related symptoms. The main reasons for re-operation were pain and infertility. The median time to re-operation was 2.1 years. Conclusions: In this extraordinarily long follow-up with a remarkable response rate, we show that surgical treatment of DE leads to pain relief and improved fertility in most cases. However, the risk of recurrence and the need for re-operation remains remarkable.

Novel workflow analysis of robot-assisted hysterectomy through objective performance indicators: a pilot study.

Introduction: The curriculum for a da Vinci surgeon in gynecology requires special training before a surgeon performs their first independent case, but standardized, objective assessments of a trainee's workflow or skills learned during clinical cases are lacking. This pilot study presents a methodology to evaluate intraoperative surgeon behavior in hysterectomy cases through standardized surgical step segmentation paired with objective performance indicators (OPIs) calculated directly from robotic data streams. This method can provide individual case analysis in a truly objective capacity. Materials and methods: Surgical data from six robot-assisted total laparoscopic hysterectomies (rTLH) performed by two experienced surgeons was collected prospectively using an Intuitive Data Recorder. Each rTLH video was annotated and segmented into specific, functional surgical steps based on the recorded video. Once annotated, OPIs were compared through workflow analysis and across surgeons during two critical surgical steps: colpotomy and vaginal cuff closure. Results: Through visualization of the individual steps over time, we observe workflow consistencies and variabilities across individual surgeons of a similar experience level at the same hospital, creating unique surgeon behavior signatures across each surgical case. OPI differences across surgeons were observed for both the colpotomy and vaginal cuff closure steps, specifically reflecting camera movement, energy usage and clutching behaviors. Comparing colpotomy and vaginal cuff closure time needed for the step and the events of energy use were significantly different (p < 0.001). For the comparison between the two surgeons only the event count for camera movement during colpotomy showed significant differences (p = 0.03). Conclusion: This pilot study presents a novel methodology to analyze and compare individual rTLH procedures with truly objective measurements. Through collection of robotic data streams and standardized segmentation, OPI measurements for specific rTLH surgery steps can be reliably calculated and compared to those of other surgeons. This provides opportunity for critical standardization to the gynecology field, which can be integrated into individualized training plans in the future. However, more studies are needed to establish context surrounding these metrics in gynecology.

Prevention of peritoneal adhesions after gynecological surgery: a systematic review.

IMPORTANCE: The formation of adhesions after gynecological surgery not only has detrimental impacts on those affected, including pain, obstruction, and infertility, but also imposes a high economic burden on healthcare systems worldwide. OBJECTIVE: The aim of this review was to evaluate the adhesion prevention potential of all currently available adhesion barriers for gynecological surgery. EVIDENCE ACQUISITION: We systematically searched MEDLINE and CENTRAL databases for randomized controlled trials (RCTs) on the use of adhesion barriers as compared with peritoneal irrigation or no treatment in gynecological surgery. Only RCTs with second-look surgery to evaluate adhesions in the pelvic/abdominal (but not intrauterine) cavity were included. RESULTS: We included 45 RCTs with a total of 4,120 patients examining a total of 10 unique types of barriers in second-look gynecological surgery. While RCTs on oxidized regenerated cellulose (significant improvement in 6 of 14 trials), polyethylene glycol with/without other agents (4/10), hyaluronic acid and hyaluronate + carboxymethylcellulose (7/10), icodextrin (1/3), dextran (0/3), fibrin-containing agents (1/2), expanded polytetrafluoroethylene (1/1), N,O-carboxymethylchitosan (0/1), and modified starch (1/1) overall showed inconsistent findings, results for expanded polytetrafluoroethylene, hyaluronic acid, and modified starch yielded the greatest improvements regarding adhesion reduction at 75%, 0-67%, and 85%, respectively. CONCLUSIONS AND RELEVANCE: Best results for adhesion prevention were reported after applying Gore-Tex Surgical Membrane, hyaluronic acid, and 4DryField®. As Gore-Tex Surgical Membrane is nonabsorbable, it is associated with a greater risk of new adhesion formation due to second-look surgery to remove the product. 4DryField® yielded the greatest improvement in adhesion score compared to all other barrier agents (85%). For better comparability, future studies should use standardized scores and put more emphasis on patient-reported outcome measures, such as pain and infertility.

Optical Emission Spectroscopy for the Real-Time Identification of Malignant Breast Tissue.

Breast conserving resection with free margins is the gold standard treatment for early breast cancer recommended by guidelines worldwide. Therefore, reliable discrimination between normal and malignant tissue at the resection margins is essential. In this study, normal and abnormal tissue samples from breast cancer patients were characterized ex vivo by optical emission spectroscopy (OES) based on ionized atoms and molecules generated during electrosurgical treatment. The aim of the study was to determine spectroscopic features which are typical for healthy and neoplastic breast tissue allowing for future real-time tissue differentiation and margin assessment during breast cancer surgery. A total of 972 spectra generated by electrosurgical sparking on normal and abnormal tissue were used for support vector classifier (SVC) training. Specific spectroscopic features were selected for the classification of tissues in the included breast cancer patients. The average classification accuracy for all patients was 96.9%. Normal and abnormal breast tissue could be differentiated with a mean sensitivity of 94.8%, a specificity of 99.0%, a positive predictive value (PPV) of 99.1% and a negative predictive value (NPV) of 96.1%. For 66.6% patients all classifications reached 100%. Based on this convincing data, a future clinical application of OES-based tissue differentiation in breast cancer surgery seems to be feasible.

The Effect of an Interdisciplinary Dermatological-Rheumatological Consultation on the Outcome of Patients with Psoriasis with Musculoskeletal Pain: A Prospective, Single-Center Cohort Study.

INTRODUCTION: Psoriatic arthritis (PsA), a disease with complex inflammatory musculoskeletal manifestations, complicates psoriasis in up to 30% of patients. In this study, we aimed to determine the effect of an interdisciplinary dermatological-rheumatological consultation (IDRC) for patients with psoriasis with musculoskeletal symptoms. METHODS: This prospective study enrolled 202 patients with psoriasis. Patients with musculoskeletal pain (MSP) (n = 115) participated in an IDRC 12 weeks after enrollment. The outcome was evaluated after 24 weeks. RESULTS: In 12/79 (15.2%) patients seen in the IDRC, the prior diagnosis was changed: eight with a first diagnosis of PsA, four with a diagnosis of PsA rescinded. Treatment was modified in 28% of patients. Significant improvements in Psoriasis Area and Severity Index (PASI) (from 5.3 to 2.0; p < 0.001) and Dermatology Life Quality Index (DLQI) (from 6.7 to 4.5; p = 0.009) were observed. By comparing changes in PASI and DLQI over the study period, an improvement in PASI of 0.7 ± 1.4 points (p = 0.64) and in DLQI of 2.9 ± 1.5 points (p = 0.051) could be attributed to participation in the IDRC. CONCLUSION: An IDRC of patients with psoriasis with MSP leads to a valid diagnosis of PsA and improvement in quality of life. Based on these results, an IDRC is a valuable and time efficient way for psoriasis patient with MSP to receive optimal care.

Hybrid argon plasma coagulation (HybridAPC) versus sharp excision for the treatment of endometriosis: a prospective randomized clinical trial.

PURPOSE: Endometriosis is a benign, but potentially serious gynaecological condition in terms of abdominal pain and impaired fertility. Laparoscopic excision techniques are considered the therapeutic standard. HybridAPC is presented as a novel technique for the non-contact thermal ablation of peritoneal endometriosis with simultaneous protection of the underlying thermosensitive structures by creating a needle-free elevated fluid cushion which enables a safer exposure and distance, as well as potentially improved peritoneal conditioning prior to APC. METHODS: In this prospective randomized clinical trial, 39 patients with 132 superficial endometriotic lesions in total were treated with HybridAPC or sharp excision in an initial laparoscopic procedure according to randomization. In a second-look laparoscopy, adhesion formation was rated macroscopically. Histologic samples were taken from previously treated areas for evaluation of eradication rate. RESULTS: The eradication rate was not significantly different between HybridAPC treatment and sharp excision (65 vs. 81%, p = .55). Adhesions formed in 5% of HybridAPC-treated lesions and in 10% after sharp excision (p = .49). HybridAPC treatment was significantly faster than sharp excision (69 vs. 106 s, p < .05). No intra- and postoperative complications were registered. CONCLUSION: This clinical trial demonstrates the feasibility of this novel surgical technique with a promising impact on adhesion prevention. Compared to sharp excision, HybridAPC is likely to be a safe, tissue-preserving, and fast method for the treatment of peritoneal endometriosis.

Increased FOXJ1 protein expression is associated with improved overall survival in high-grade serous ovarian carcinoma: an Ovarian Tumor Tissue Analysis Consortium Study.

BACKGROUND: Recently, we showed a >60% difference in 5-year survival for patients with tubo-ovarian high-grade serous carcinoma (HGSC) when stratified by a 101-gene mRNA expression prognostic signature. Given the varied patient outcomes, this study aimed to translate prognostic mRNA markers into protein expression assays by immunohistochemistry and validate their survival association in HGSC. METHODS: Two prognostic genes, FOXJ1 and GMNN, were selected based on high-quality antibodies, correlation with protein expression and variation in immunohistochemical scores in a preliminary cohort (n = 134 and n = 80, respectively). Six thousand four hundred and thirty-four (FOXJ1) and 5470 (GMNN) formalin-fixed, paraffin-embedded ovarian neoplasms (4634 and 4185 HGSC, respectively) represented on tissue microarrays from the Ovarian Tumor Tissue Analysis consortium underwent immunohistochemical staining and scoring, then univariate and multivariate survival analysis. RESULTS: Consistent with mRNA, FOXJ1 protein expression exhibited a linear, increasing association with improved overall survival in HGSC patients. Women with >50% expression had the most favourable outcomes (HR = 0.78, 95% CI 0.67-0.91, p < 0.0001). GMNN protein expression was not significantly associated with overall HSGC patient survival. However, HGSCs with >35% GMNN expression showed a trend for better outcomes, though this was not significant. CONCLUSION: We provide foundational evidence for the prognostic value of FOXJ1 in HGSC, validating the prior mRNA-based prognostic association by immunohistochemistry.

A new bipolar device for sealing and cutting: ex and in vivo studies for performance evaluation.

INTRODUCTION: A novel multipurpose bipolar radiofrequency instrument, the Erbe Dissector (EDS), which simultaneously seals and cuts tissue, was developed. Ex vivo sealing rate and time, burst pressure, jaw temperature and thermal spread were studied in porcine renal arteries. MATERIAL AND METHODS: In vivo, 13 surgical tasks were performed in two pigs: beside sealing rate and time, overall performance in sharp and blunt dissection, tissue sticking, hemostasis, precision, etc., were evaluated by four surgeons compared with ENSEAL G2 (EG2) using surveys on a Likert scale (1 = very poor; 5 = very good). RESULTS: Ex vivo, the EDS sealing rate was 91.7% (33/36 arteries) at an average sealing time of 2.1 s (range 1.7-2.8) and a burst pressure of 1040 ± 350 mmHg. The maximum jaw temperature was 87 ± 4 °C and the mean lateral thermal spread was 0.8 ± 0.2 mm. In vivo, the sealing rate for arteries and veins was 92.6% (50/54) and the median seal and cut time was 1.6 s (range: 1.3-2.9). The average EDS performance score across all tasks was 4.4 ± 0.6 Likert points. For five shared tasks, EDS was better than EG2 (4.4 ± 0.5 versus 3.4 ± 0.6 Likert points; p = 0.016). CONCLUSIONS: EDS seals and cuts arteries and veins rapidly with good safety and user-friendliness.

Molecular analysis suggests oligoclonality and metastasis of endometriosis lesions across anatomically defined subtypes.

OBJECTIVE: To investigate the heterogeneity of somatic cancer-driver mutations within patients and across endometriosis types. DESIGN: A single-center cohort, retrospective study. SETTING: Tertiary specialist-care center at a university hospital. PATIENT(S): Patients with surgically and histologically confirmed endometriosis of at least 2 anatomically distinct types (ovarian, deep infiltrating, and superficial). INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Specimens were analyzed for the presence or absence of somatic cancer-driver mutations using targeted panel sequencing with orthogonal validation using droplet digital polymerase chain reaction and mutation-surrogate immunohistochemistry. RESULT(S): It was found that 13 of 27 patients had informative somatic driver mutations in endometriosis lesions; of these 13 patients, 9 had identical mutations across distinct lesions. Endometriomas showed a higher mutational complexity, with functionally redundant driver mutations in the same gene and within the same lesions. CONCLUSION(S): Our data are consistent with clonality across endometriosis lesions, regardless of subtype. Further, the finding of redundancy in mutations within the same gene and lesions is consistent with endometriosis representing an oligoclonal disease with dissemination likely to consist of multiple epithelial clones traveling together. This suggests that the current anatomically defined classification of endometriosis does not fully recognize the etiology of the disease. A novel classification should consider genomic and other molecular features to promote personalized endometriosis diagnosis and care.

Large Conization-Retrospective Monocentric Results for Fertility Preservation in Young Women with Early Stage Cervical Cancer.

The shorter cervical segment after classic radical trachelectomy (RT) imposes a number of pregnancy associated risk factors. In this aspect, large conization (LC) could be an oncologically safe alternative to RT in young women with early stage cervical cancer who want to spare their fertility. Our aim was to evaluate fertility-sparing surgical treatment of early stage cervical cancer after the introduction of LC. Our objectives were to assess surgical, oncological, fertility and obstetric outcomes. We retrospectively investigated oncological and fertility outcomes of patients who underwent LC in a large oncological single University centre between 2009 and 2014. Medical records were reviewed and analysed for surgical, oncological, fertility and obstetric outcomes. Postal questionnaires were collected to further evaluate and validate the fertility and obstetric outcomes. A total of 23 LCs were analysed. Seven patients had to undergo secondary radical hysterectomy after LC due to unclear resection margins. Nine of 16 women tried to conceive, of which all nine became pregnant. Seven patients underwent a prophylactic cerclage between 13 and 16 gestational weeks and seven women delivered 9 children; the majority of women conceived spontaneously. Follow-up time was a median of 3.9 years (2.6-8 years). There was no relapse of cervical cancer in the investigated timeframe. Early stage cervical cancers treated by LC are associated with excellent oncological outcomes. LC appears to be a safe option for eligible women who intend to maintain their fertility.

Validated biomarker assays confirm that ARID1A loss is confounded with MMR deficiency, CD8+ TIL infiltration, and provides no independent prognostic value in endometriosis-associated ovarian carcinomas.

ARID1A (BAF250a) is a component of the SWI/SNF chromatin modifying complex, plays an important tumour suppressor role, and is considered prognostic in several malignancies. However, in ovarian carcinomas there are contradictory reports on its relationship to outcome, immune response, and correlation with clinicopathological features. We assembled a series of 1623 endometriosis-associated ovarian carcinomas, including 1078 endometrioid (ENOC) and 545 clear cell (CCOC) ovarian carcinomas, through combining resources of the Ovarian Tumor Tissue Analysis (OTTA) Consortium, the Canadian Ovarian Unified Experimental Resource (COEUR), local, and collaborative networks. Validated immunohistochemical surrogate assays for ARID1A mutations were applied to all samples. We investigated associations between ARID1A loss/mutation, clinical features, outcome, CD8+ tumour-infiltrating lymphocytes (CD8+ TILs), and DNA mismatch repair deficiency (MMRd). ARID1A loss was observed in 42% of CCOCs and 25% of ENOCs. We found no associations between ARID1A loss and outcomes, stage, age, or CD8+ TIL status in CCOC. Similarly, we found no association with outcome or stage in endometrioid cases. In ENOC, ARID1A loss was more prevalent in younger patients (p = 0.012) and was associated with MMRd (p < 0.001) and the presence of CD8+ TILs (p = 0.008). Consistent with MMRd being causative of ARID1A mutations, in a subset of ENOCs we also observed an association with ARID1A loss-of-function mutation as a result of small indels (p = 0.035, versus single nucleotide variants). In ENOC, the association with ARID1A loss, CD8+ TILs, and age appears confounded by MMRd status. Although this observation does not explicitly rule out a role for ARID1A influence on CD8+ TIL infiltration in ENOC, given current knowledge regarding MMRd, it seems more likely that effects are dominated by the hypermutation phenotype. This large dataset with consistently applied biomarker assessment now provides a benchmark for the prevalence of ARID1A loss-of-function mutations in endometriosis-associated ovarian cancers and brings clarity to the prognostic significance. © 2021 The Pathological Society of Great Britain and Ireland.

Prevalence and risk factors for hyperhomocysteinemia: a population-based cross-sectional study from Hunan, China.

OBJECTIVES: Hyperhomocysteinemia is an independent risk factor for cardiovascular diseases. We aimed to investigate the prevalence and risk factors for hyperhomocysteinemia, especially modifiable lifestyle factors, such as smoking behaviour and dietary factors. DESIGN: Population-based cross-sectional study. SETTING: Hunan Province, China PARTICIPANTS: A total of 4012 participants completed the study, between July 2013 and March 2014. The median age is 55 (interquartile range: 45-63) years, with 1644 males (41%) and 2368 females (59%). MAIN OUTCOME MEASURES: Homocysteine level were measured by the microplate enzyme immunoassay method. Hyperthomocysteinemia was defined as ≥15 µmol/L. Questionnaire was used to investigate potential risk factors of hyperhomocysteinemia. Crude odd ratio (OR) or adjusted OR with 95% CI were determined by using univariable or multivariable logistic regression models. RESULTS: The prevalence of hyperhomocysteinemia is 35.4% (45.4% vs 28.5% for men, women, respectively). One-year increase in age is significantly associated with 2% higher risk of hyperhomocysteinemia (OR=1.02, 95% CI: 1.01 to 1.03). One unit increase of BMI is associated with 5% higher risk of hyperhomocysteinemia (OR=1.05, 95% CI: 1.03 to 1.07). Compared with the non-smoker, smoking participants have a 24% higher risk of hyperhomocysteinemia (OR=1.24, 95% CI: 1.006 to 1.53), while the risk for those quitting smoking are not significantly different (OR=1.14, 95% CI: 0.85 to 1.54). compared with those consuming fruit and vegetable at least once every day, those consuming less than once every day had a significantly higher risk of hyperhomocysteinemia (OR=1.29, 95% CI:1.11 to 1.50). In addition, we found there were significant sex interaction with education level or alcohol drinking on the risk of hyperhomocysteinemia (pinteraction <0.05). CONCLUSIONS: Higher BMI and older age are potential risk factors for hyperhomocysteinemia. Current smoking but not quitting smoking is associated with higher risk of hyperhomocysteinemia. Fruit and vegetable consumption may have protective effect against hyperhomocysteinemia. Alcohol consumption or education level might interact to influence the risk of hyperhomocysteinemia.

Retrospective analysis of secondary resection of the cervical stump after subtotal hysterectomy: why and when?

PURPOSE: The rates of hysterectomy are falling worldwide, and the surgical approach is undergoing a major change. To avoid abdominal hysterectomy, a minimally invasive approach has been implemented. Due to the increasing rates of subtotal hysterectomy, we are faced with the following questions: how often does the cervical stump have to be removed secondarily, and what are the indications? METHODS: This was a retrospective, single-centre analysis of secondary resection of the cervical stump conducted from 2004 to 2018. RESULTS: Secondary resection of the cervical stump was performed in 137 women. Seventy-four percent of the previous subtotal hysterectomy procedures were performed in our hospital, and 26% were performed in an external hospital. During the study period, 5209 subtotal hysterectomy procedures were performed at our hospital. The three main indications for secondary resection of the cervical stump were prolapse (31.4%), spotting (19.0%) and cervical dysplasia (18.2%). Unexpected histological findings (premalignant and malignant) after subtotal hysterectomy resulted in immediate (median time, 1 month) secondary resection of the cervical stump in 11 cases. In four patients, the indication was a secondary malignant gynaecological disease that occurred more than 5 years after subtotal hysterectomy. The median time between subtotal hysterectomy and secondary resection of the cervical stump was 40 months. Secondary resection of the cervical stump was performed vaginally in 75.2% of cases, laparoscopically in 20.4% of cases and abdominally in 4.4% of cases. The overall complication rate was 5%. CONCLUSION: Secondary resection of the cervical stump is a rare surgery with a low complication rate and can be performed via the vaginal or laparoscopic approach in most cases. The most common indications are prolapse, spotting and cervical dysplasia. If a secondary resection of the cervical stump is necessary due to symptoms, 66.6% will be performed within the first 6 years after subtotal hysterectomy.

The Status Quo of Rare Diseases Centres for the Development of a Clinical Decision Support System - A Cross-Sectional Study.

Clinical decision support systems (CDSS) help to improve the diagnostics and treatment of rare diseases (RD). As one of four funded consortia of the Medical Informatics Initiative supported by the Federal Ministry of Education and Research (BMBF, Germany), MIRACUM develops a clinical decision support system (CDSS) for RD based on distributed data of ten university hospitals. The CDSS will be developed at the Rare Diseases Centres (RDC) of the MIRACUM consortium. Since it is essential to deliver decision support at the right time and place in the clinician's workflow, this study aimed to capture relevant information of the RDCs regarding patient admission and diagnostic process. Additionally, we investigated how patient documentation and digitalisation is performed at the centres. Therefore, we conducted a cross-sectional survey involving experts in the RDs domain to capture relevant information for the further development of a CDSS in RD. For each centre, one expert on RDs participated in the study (n=8). The survey identified several challenges regarding the reuse of patient data, e.g. the paper-based documentation of a patientâAZs medical history and coding of diagnoses using ICD-10. However, we noticed a relevant use of current software diagnosis support and a similarly performed diagnostic process in all RDC. Further studies are needed to get more detailed insights and to define specific requirements.

Outcomes of severe limb ischemia with tissue loss and impact of revascularization in haemodialysis patients with wound, ischemia, and foot infection (WIfI) stage 3 or 4.

Background: With growing prevalence, end-stage renal disease (ESRD) as well as critical limb ischemia (CLI) are both conditions associated with high morbidity and mortality rates. Patients and methods: A retrospective single-centre study provided data of a German interdisciplinary vascular centre. Seventy-seven consecutive haemodialysis (HD) inpatients (median age, 73.6 years) with 91 threatened limbs with Wound, Ischemia, and foot Infection (WIfI) clinical stage 3 or 4 were evaluated for in-hospital treatment of peripheral arterial disease, limb salvage rates, major amputation (MA)-free and overall survival. Results: The 1-year MA-free limb salvage rate was 82 %. On multivariate analysis, a higher WIfI clinical stage (hazard ratio [HR], 7.54; p = 0.008) indicated a higher risk of MA, while at least one-vessel run-off to the foot after revascularization of any kind was associated with a lower risk of MA (HR, 0.17; p = 0.001). In the composite endpoint analysis, the 1-year MA-free overall survival rate was 65 %. Patients with limbs in WIfI clinical stage 4 versus stage 3 carried a more than two-fold increased hazard of death or MA (HR, 2.63; p = 0.028), while revascularization was associated with reduced risk (HR, 0.40; p = 0.021). One-year overall survival (78 %) was not associated with WIfI stage or revascularization but was worse in patients with previous symptomatic coronary artery disease (HR, 3.25; p = 0.039). During long-term follow-up over 12 years, MA-free survival probability was significantly lower in the WIfI stage 4 versus WIfI stage 3 group (HR, 1.58; p = 0.048) without significant differences in overall survival (HR, 1.10; p = 0.696). Conclusions: Lower-extremity CLI with tissue loss in HD patients is associated with high morbidity and mortality rates. WIfI clinical stage was predictive of 1-year MA-free survival, while revascularization significantly reduced MA risk but did not influence overall survival.

Safety and effectiveness of a novel generator algorithm for bipolar vessel sealing: a randomised controlled chronic animal study.

BACKGROUND: Electrosurgical vessel sealers are gradually replacing conventional techniques such as ligation and clipping. Algorithms that control electrosurgical units (ESU), known as modes, are important for applications in different surgical disciplines. This chronic porcine animal study aimed to evaluate the safety and effectiveness of the novel thermoSEAL electrosurgical vessel sealing mode (TSM). The BiClamp® mode (BCM) of the renowned VIO® 300 D ESU served as control. BCM has been widely available since 2002 and has since been successfully used in many surgical disciplines. The TSM, for the novel VIO® 3 ESU, was developed to reduce sealing time and/or thermal lateral spread adjacent to the seal while maintaining clinical success rates. The primary aim of this study was to investigate the long-term and intraoperative seal quality of TSM. METHODS: The BiCision® device was used for vessel sealing with TSM and BCM in ten German Landrace pigs which underwent splenectomy and unilateral nephrectomy during the first intervention of the study. The seals were cut with the BiCision® knife. Ninety-nine arteries, veins and vascular bundles were chronically sealed for 5 or 21 days. Thereafter, during the second and terminal intervention of the study, 97 additional arteries and veins were sealed. The carotid arteries were used for histological evaluation of thermal spread. RESULTS: After each survival period, no long-term complications occurred with either mode. The intraoperative seal failure rates, i.e. vessel leaking or residual blood flow after the first sealing activation, were 2% with TSM versus 6% with BCM (p = 0.28). The sealing time was significantly shorter with TSM (3.5 ± 0.69 s vs. 7.3 ± 1.3 s, p < 0.0001). The thermal spread and burst pressure of arteries sealed with both modes were similar (p = 0.18 and p = 0.61) and corresponded to the histological evaluation. The measured tissue sticking parameter was rare with both modes (p = 0.33). Tissue charring did not occur. Regarding the cut quality, 97% of the seals were severed in the first and 3% in the second attempt (both with TSM and BCM). CONCLUSIONS: The novel TSM seals blood vessels twice as fast as the BCM while maintaining excellent tissue effect and clinical success rates. TRIAL REGISTRATION: Not applicable.

Identification and injury to the inferior hypogastric plexus in nerve-sparing radical hysterectomy.

Waterjet dissection of the inferior hypogastric plexus (IHP) resulted in a more rapid return of normal urodynamics than blunt dissection (control group) in patients who received laparoscopic nerve-sparing radical hysterectomy (NSRH) in a randomized controlled study. However, the definite reasons for these results were unknown. This subgroup analysis compared the neural areas and impairment in the IHP uterine branches harvested during NSRH as an alternative to the IHP vesical branches between the waterjet and control groups. This study included samples from 30 eligible patients in each group of the trial NCT03020238. At least one specimen from each side of the IHP uterine branches was resected. The tissues were scanned, images were captured, and the neural component areas were calculated using the image segmentation method. Immunohistochemical staining was used to evaluate neural impairment. The control and waterjet groups had similar areas of whole tissues sent for evaluation. However, the control group had significantly fewer areas (median 272158 versus 200439 µm2, p = 0.044) and a lower percentage (median 4.9% versus 3.0%, p = 0.011) of neural tissues. No significant changes in immunohistochemical staining were found between the two groups. For patients with residual urine ≤100 and >100 ml at 14 days after NSRH (42 and 18 patients, respectively), there were significantly different percentages of neural tissues in the resected samples (p < 0.001). Hence, Due to the accurate identification of IHP during NSRH, the waterjet dissection technique achieved better urodynamic results.

An ergonomic field study to evaluate the effects of a rotatable handle piece on muscular stress and fatigue as well as subjective ratings of usability, wrist posture and precision during laparoscopic surgery: an explorative pilot study.

PURPOSE: The interface between surgeon and the laparoscopic instrument is an important factor in biomechanical stress that may increase the risk of musculoskeletal complaints in surgeons. This article investigates the effect of a laparoscopic instrument with a rotatable handle piece (rot-HP) on muscular stress and fatigue during routine laparoscopic procedures (LP) as well as usability, wrist posture and working precision. METHODS: 40 LP (subtotal hysterectomies) performed by 11 surgeons were investigated. 20 LP were carried out with the rot-HP and 20 with a fixed (standard) laparoscopic handle piece instrument. Shoulder and arm muscle activity was monitored via surface electromyography (sEMG). The electrical activity (EA) and median power frequency (MPF) were used to determine muscular stress and fatigue. Usability, wrist posture, and working precision between handle piece conditions were assessed by a survey. RESULTS: Using the rot-HP did not reduce muscular stress. A tendency of muscular fatigue (increasing EA, decreasing MPF) occurred in the upper trapezius, middle deltoid and extensor digitorum muscles; however, no differences were found between handle pieces. Wrist posture was more comfortable using the rot-HP and working precision and usability tended to be preferred using the standard handle piece. CONCLUSIONS: Although wrist posture seemed to be optimized by the rot-HP, no effect on muscular stress and fatigue was observed in routine LP (< 60 min duration). Optimization of wrist posture may provide positive effects in mid- or long-term procedures. However, sufficient familiarization with the new instrument is crucial since working precision and usability could be impaired.

A prospective randomized experimental study to investigate the peritoneal adhesion formation after waterjet injection and argon plasma coagulation (HybridAPC) in a rat model.

BACKGROUND: This prospective, randomized, controlled, single-blinded study investigates the peritoneal adhesion formation of HybridAPC (waterjet elevation of the peritoneum with subsequent argon plasma coagulation) versus only waterjet (elevation with the same instrument, but without subsequent argon plasma coagulation) in a rat model (24 female Wistar rats). MATERIALS AND METHODS: Bilateral lesions were created on the abdominal wall with HybridAPC on one sidewall and waterjet elevation on the other sidewall of the peritoneum in a standard fashion. After 10 days, the rats were euthanized to evaluate the peritoneal trauma sites. MAIN OUTCOME MEASURE(S): Adhesion incidence, quantity, and quality were scored 10 days postoperatively and studied histopathologically. RESULT(S): Incidence of adhesion formation was 2.3% for HybridAPC; no adhesions occurred for peritoneal elevation with saline (p = 1.00). Histologic evaluation revealed no acute inflammation in both groups. An overall moderate degree of granulation tissue formation and myonecrosis was observed in the HybridAPC group, whereas no chronic inflammation and myonecrosis occurred after elevation without thermal ablation (p < 0.0001). CONCLUSION(S): This study investigates the effect of waterjet elevation of the peritoneum with and without subsequent thermal ablation on adhesion formation in a rat model for the first time. Peritoneal waterjet elevation with saline does not provide any risk of adhesion formation. Thermal coagulation with APC after waterjet elevation of the peritoneum creates advantageous peritoneal conditions due to a permanent moist tissue surface and the cooling effect of the injected solution, resulting in no significant difference in adhesion formation compared to peritoneal elevation without thermal ablation. HybridAPC can thus be regarded as a beneficial coagulation method with only minor adhesion formation due to positive tissue effects of the combined waterjet.