Continuous intraoperative monitoring of pelvic autonomic nerves during TME to prevent urogenital and anorectal dysfunction in rectal cancer patients (NEUROS): a randomized controlled trial.

BACKGROUND: Urinary, sexual and anorectal sequelae are frequent after rectal cancer surgery and were found to be related to intraoperative neurogenic impairment. Neuromonitoring methods have been developed to identify and preserve the complex pelvic autonomic nervous system in order to maintain patients' quality of life. So far no randomized study has been published dealing with the role of neuromonitoring in rectal cancer surgery. METHODS/DESIGN: NEUROS is a prospective two-arm randomized controlled multicenter clinical trial comparing the functional outcome in rectal cancer patients undergoing total mesorectal excision (TME) with and without pelvic intraoperative neuromonitoring (pIONM). A total of 188 patients will be included. Primary endpoint is the urinary function measured by the International Prostate Symptom Score. Secondary endpoints consist of sexual, anorectal functional outcome and safety, especially oncologic safety and quality of TME. Sexual function is assessed in females with the Female Sexual Function Index and in males with the International Index of Erectile Function. For evaluation of anorectal function the Wexner-Vaizey score is used. Functional evaluation is scheduled before radiochemotherapy (if applicable), preoperatively (baseline), before hospital discharge, 3 and 6 months after stoma closure and 12 months after surgery. For assessment of safety adverse events, the rates of positive resection margins and quality of mesorectum are documented. DISCUSSION: This study will provide high quality evidence on the efficacy of pIONM aiming for improvement of functional outcome in rectal cancer patients undergoing TME. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01585727 . Registration date is 04/25/2012.

Electrophysiology-based quality assurance of nerve-sparing in laparoscopic rectal cancer surgery: Is it worth the effort?

BACKGROUND: After low anterior resection for rectal cancer, visual assessment of pelvic autonomic nerve preservation can be difficult due to the complexity of neuroanatomy, as well as surgery- and patient-related factors. The present study aimed to evaluate nerve-sparing quality assurance using the laparoscopic neuromapping (LNM) technique. METHODS: We prospectively investigated a series of 30 patients undergoing laparoscopic low anterior resection. Nerve-sparing was evaluated both visually and electrophysiologically. LNM was performed using stimulation of pelvic autonomic nerves under simultaneous cystomanometry and processed electromyography of the internal anal sphincter. Urogenital and anorectal functions were evaluated using validated and standardized questionnaires preoperatively, at short-term follow-up, and at mid-term follow-up at a median of 9 months (range 6-12 months) after surgery. RESULTS: One patient reported new onset of urinary dysfunction, and another patient reported new onset of anorectal dysfunction. Of the 20 sexually active patients, five reported sexual dysfunction. Visual assessment by laparoscopy confirmed complete nerve preservation in 28 of 30 cases. For prediction of urinary and anorectal function, LNM sensitivity, specificity, positive and negative predictive value, and overall accuracy were each 100 %. LNM with combined assessment for prediction of sexual function yielded a sensitivity of 80 %, specificity of 93 %, positive predictive value of 80 %, negative predictive value of 93 %, and overall accuracy of 90 %. CONCLUSIONS: LNM is an appropriate method for reliable quality assurance of laparoscopic nerve-sparing.

Midterm functional results of taTME with neuromapping for low rectal cancer.

BACKGROUND: Information on functional outcomes after laparoscopic-assisted transanal total mesorectal excision (taTME) is limited. This study analyzed the functional results in patients with low rectal cancer. METHODS: Ten consecutive patients (nine males) undergoing electrophysiologically controlled nerve-sparing taTME were investigated prospectively and asked to complete functional questionnaires [the International Prostate Symptom Score (IPSS), International Index of Erectile Function, Female Sexual Function Index, Wexner score, and low anterior resection syndrome (LARS) score]. Bladder function was also assessed according to residual urine volume. Preoperative function was compared to the functional outcome 3 and 6 months, and 9 months if eligible, after stoma closure or surgery in the absence of a diverting stoma. RESULTS: Prior to therapy, urinary and sexual function was impaired in 40 and 60% of patients, respectively. None of the patients developed pathological residual urine volumes after at least unilateral functional pelvic nerve-sparing. Median IPSS was lower than preoperative scores (p > 0.05). Two males with incomplete nerve preservation were considered impotent during a median follow-up of 15 months (range 6-20 months). The female was judged to be sexually inactive. The median Wexner score was 1 (range 0-7) prior to any therapy and increased to 7 (range 0-15) at 6 months (p = 0.029), with 40% of patients categorized as having no LARS and 50% minor LARS. The median LARS score was 28 (range 9-38) at 3 months and 26 (range 9-32) at 6 months (p = 0.165). CONCLUSIONS: Despite a small sample size and confounding factors, data indicate that taTME has the potential to preserve continence, sufficient bowel function, and urogenital function.

Impact of inhalation vs. intravenous anaesthesia on autonomic nerves and internal anal sphincter tone.

BACKGROUND: Pelvic intraoperative neuromonitoring (pIONM) aims to identify and spare the autonomic nerves and maintain patients' quality of life. The effect of anaesthetic agents on the pIONM signal is unknown; therefore, the aim of the present study was to compare the influences of inhalation anaesthesia (IA) and total intravenous anaesthesia (TIVA). METHODS: Twenty rectal cancer patients undergoing open nerve-sparing total mesorectal excision (TME) were assigned to pIONM under either IA or TIVA (n = 10 per group). IA was maintained with sevoflurane and TIVA with propofol. During surgery, pelvic autonomic nerves were electrically stimulated under electromyography (EMG) of the internal anal sphincter (IAS). These triggered EMG signals were analysed. RESULTS: The absolute EMG amplitude during pIONM increased to 1.20 µV (interquartile range (IQR): 0.94-1.6) for IA and 1.49 µV (IQR: 0.84-2.75) for TIVA (P = 0.002). The relative EMG amplitude increase also was significantly lower for IA (0.59; IQR: 0.30-0.81; TIVA: 0.99; IQR: 0.62-2.5), (P = 0.001). CONCLUSIONS: This is the first study to compare the influences of IA and TIVA on the autonomic nervous system. While both anaesthetic regimens proved useful for pIONM, TIVA with propofol may provide better signal quality than IA with sevoflurane.

Preconditioning in laparoscopic surgery--results of a virtual reality pilot study.

BACKGROUND: This prospective study investigated the effect of preconditioning in laparoscopic cholecystectomy (LC) and appendectomy (LA) based on pre- and postoperative virtual reality laparoscopy (VRL) performances, with specific regard to the impact of different motor skills, types of surgery and levels of experience. STUDY DESIGN: Forty laparoscopic procedures (28 LC and 12 LA) were performed by 13 residents in the operating room. Participants completed a defined set of tasks on the VRL simulator directly prior to and after the operation: one preparational task (PT), a virtual procedural task with emphasis on fine preparation (VPT) and a navigational manoeuvre for instrument coordination (ICT). VRL performances were evaluated based on the assessed items of the simulator. RESULTS: Overall analysis of the surgeons' performance demonstrated better postoperative results for PT and VPT in 28 and 26 cases (p = 0.001 and p = 0.034), respectively. No significant difference was found for ICT (p = 0.638). Less-experienced residents had better postoperative results for PT and VPT (p = 0.009 and p = 0.041), whereas more-experienced surgeons had better postoperative results for PT only (p = 0.030). LC resulted in better postoperative performance for PT (p = 0.007). LA improved performance for PT and VPT (p = 0.034 and p = 0.006, respectively). Comparisons of surgeon's experience demonstrated a significant advantage for more-experienced surgeons in ICT (p = 0.033), while type of surgery showed an advantage for LA in VPT (p = 0.022). CONCLUSION: There is a preconditioning effect in laparoscopic surgery. The differing results related to LC and LA and the experience levels of surgeons suggest that differentiated warm-up strategies are required.

Percutaneous nerve evaluation based on electrode placement under control of autonomic innervation.

BACKGROUND: Foramen needle electrode placement for percutaneous nerve evaluation (PNE) is currently carried out while observing the somatic motor response. This study investigated electrode placement while observing the autonomic as well as the somatic response. METHODS: A consecutive series of ten patients (seven women) with a median age of 51.9 (range 30-75) years undergoing PNE for faecal incontinence (n = 6) and obstipation (n = 4) were investigated prospectively. Electrode placement was carried out under simultaneous electromyography (EMG) of the external anal sphincter (EAS) and internal anal sphincter (IAS) and cystomanometry. RESULTS: PNE under control of somatic and autonomic nerve responses was carried out in all patients. In three out of ten patients, initial needle electrode placement showed single evoked EMG signals from the EAS. Final electrode placement resulted in adequate somatic motor and autonomic responses in all patients. Comparison of the increases in IAS EMG amplitude on the right and left stimulation sites for sacral nerves S3 and S4 demonstrated significant differences [S3 right: median 15.3 (interquartile range (IQR) 10.4; 20.1) µV vs. S3 left: median 11.6 (IQR 8.6; 16.0) µV, p = 0.034 and S4 right: median 24.1 (IQR 20.1; 37.2) µV vs. S4 left: median 12.0 (IQR 10.7; 13.7) µV, p = 0.012]. Stimulation-induced bladder activation was achieved in all seven patients with concomitant urinary dysfunction. CONCLUSIONS: Control of not just the somatic motor response but also the autonomic nerve response during foramen needle electrode placement may objectify PNE.

Evaluation of two-dimensional intraoperative neuromonitoring for predicting urinary and anorectal function after rectal cancer surgery.

PURPOSE: The aim of this study was to compare the results of two-dimensional intraoperative neuromonitoring (IONM) with the postoperative urinary and anorectal function of rectal cancer patients. METHODS: A consecutive series of 35 patients undergoing low anterior resection were investigated prospectively. IONM was performed with electric stimulations of the pelvic splanchnic nerves under simultaneous manometry of the bladder and electromyography (EMG) of the internal anal sphincter (IAS). Urinary and anorectal function were evaluated preoperatively and at follow-up by standardized questionnaires, digital rectal examination scoring system, and long-term catheterization rate. RESULTS: The rate of postoperative newly developed bladder dysfunction was 17 %. IONM with bladder manometry had a sensitivity of 100 %, specificity of 96 %, positive predictive value of 83 %, negative predictive value of 100 %, and overall accuracy of 97 %, respectively. The proportion of patients with severely impaired anorectal function at follow-up was 8 %. The sensitivity, specificity, and positive and negative predictive values for IONM with EMG of the IAS were, respectively, 100, 96, 67, and 100 % with an accuracy of 96 %. The degree of agreement for IONM with EMG of the IAS was good for anorectal function (к = 0.780) and poor for urinary function (к = 0.119). IONM with bladder manometry yielded a very good degree of agreement for urinary function (к = 0.891) and a fair agreement for anorectal function (к = 0.336). CONCLUSIONS: The two-dimensional IONM method is suitable for verification of bladder and IAS innervation. Accurate prediction of urinary and anorectal function necessitates both bladder manometry and EMG of the IAS.

Continuous intraoperative monitoring of autonomic nerves during low anterior rectal resection: an innovative approach for observation of functional nerve integrity in pelvic surgery.

PURPOSE: The aim of this study was to develop a methodological setup for continuous intraoperative neuromonitoring with intent to improve nerve-sparing pelvic surgery. METHODS: Fourteen pigs underwent low anterior rectal resection. Continuous stimulation of pelvic autonomic nerves was carried out with a newly developed tripolar surface electrode during lateral, anterolateral, and anterior mesorectal dissection. Neuromonitoring was performed under electromyography of the autonomic innervated internal anal sphincter. RESULTS: Continuous neuromonitoring resulted in significantly increased electromyographic amplitudes of the internal anal sphincter, confirming intact innervation throughout the whole dissection in each animal (median 0.9 µV, interquartile range 0.5; 1.5 vs. median 3.4 µV, interquartile range 2.1; 4.7) (p < 0.001). The median dissection time in each animal was 10 min within a median number of ten (range 8-13) tripolar electric stimulations. CONCLUSION: The present study is the first to demonstrate that continuous intraoperative monitoring of pelvic autonomic nerves during low anterior rectal resection is feasible.

Online signal processing of internal anal sphincter activity during pelvic autonomic nerve stimulation: a new method to improve the reliability of intra-operative neuromonitoring signals.

AIM: Intra-operative neuromonitoring is increasingly applied in several surgical disciplines and has been introduced to facilitate pelvic autonomic nerve preservation. Nevertheless, it has been considered a questionable tool for the minimization of risk, as the results are variable and might be misleading. The aim of the present experimental study was to develop an intra-operative neuromonitoring system with improved reliability for monitoring pelvic autonomic nerve function. METHOD: Fifteen pigs underwent low anterior rectal resection with pelvic autonomic nerve preservation. Intra-operative neuromonitoring was performed under autonomic nerve stimulation with observation of electromyographic signals of the internal anal sphincter and bladder manometry. As the internal anal sphincter frequency spectrum during stimulation was found to be mainly in the range of 5-20 Hz, intra-operative neuromonitoring signals were postoperatively processed by implementation of matching band pass filters. RESULTS: In 10 preliminary experiments, signal processing was performed offline in the postoperative analysis. Of 163 stimulations intra-operatively assessed by the surgeon as positive responses, 135 (83%) were confirmed after signal processing. In the following five consecutive experiments intra-operative online signal processing was realized and demonstrated reliable intra-operative neuromonitoring signals of internal anal sphincter activity with significant increase during pelvic autonomic nerve stimulation [0.5 µV (interquartile range = 0.3-0.7) vs 4.8 µV (interquartile range = 2.5-7.5); P < 0.001]. CONCLUSION: Online signal processing of internal anal sphincter activity aids reliable identification of pelvic autonomic nerves with potential for improvement of intra-operative neuromonitoring in pelvic surgery.

Selective pelvic autonomic nerve stimulation with simultaneous intraoperative monitoring of internal anal sphincter and bladder innervation.

BACKGROUND: Pelvic autonomic nerve preservation avoids postoperative functional disturbances. The aim of this feasibility study was to develop a neuromonitoring system with simultaneous intraoperative verification of internal anal sphincter (IAS) activity and intravesical pressure. METHODS: 14 pigs underwent low anterior rectal resection. During intermittent bipolar electric stimulation of the inferior hypogastric plexus (IHP) and the pelvic splanchnic nerves (PSN), electromyographic signals of the IAS and manometry of the urinary bladder were observed simultaneously. RESULTS: Stimulation of IHP and PSN as well as simultaneous intraoperative monitoring could be realized with an adapted neuromonitoring device. Neurostimulation resulted in either bladder or IAS activation or concerted activation of both. Intravesical pressure increase as well as amplitude increase of the IAS neuromonitoring signal did not differ significantly between stimulation of IHP and PSN [6.0 cm H(2)O (interquartile range [IQR] 3.5-9.0) vs. 6.0 cm H(2)O (IQR 3.0-10.0) and 12.1 µV (IQR 3.0-36.7) vs. 40.1 µV (IQR 9.0-64.3)] (p > 0.05). CONCLUSIONS: Pelvic autonomic nerve stimulation with simultaneous intraoperative monitoring of IAS and bladder innervation is feasible. The method may enable neuromonitoring with increasing selectivity for pelvic autonomic nerve preservation.

[Lymphadenectomy in oncological visceral surgery-Part 2 : Cancer of the upper and lower intestinal tract]. / Lymphadenektomie in der onkologischen Viszeralchirurgie ­ Teil 2 : Karzinome des oberen und unteren Intestinaltraktes.

In cancers of the upper and lower intestinal tract the risk of lymphatic metastases depends on the histological results, tumor grading, and depth of tumor infiltration (T-stage). Pretherapeutic staging is of particular importance for determining the surgical strategy (local excision vs. en bloc resection with regional lymphadenectomy) as well as for evaluating the necessity of neoadjuvant therapy. While the first part on "Lymphadenectomy in oncological visceral surgery" focused on hepatobiliary and pancreatic cancer, this second part contains an overview of anatomical conditions of lymphatic drainage of the esophagus, stomach, duodenum, small intestine, colon, rectum and anus. Based on this, the principles and techniques of lymphadenectomy for cancer in these organs and the requirements on systematic regional lymphadenectomy in the actual TNM classification (8th edition) are discussed.

Transcutaneous sacral nerve stimulation for intraoperative verification of internal anal sphincter innervation.

BACKGROUND: The current standard for pelvic intraoperative neuromonitoring (pIONM) is based on intermittent direct nerve stimulation. This study investigated the potential use of transcutaneous sacral nerve stimulation for non-invasive verification of pelvic autonomic nerves. METHODS: A consecutive series of six pigs underwent low anterior rectal resection. For transcutaneous sacral nerve stimulation, an array of ten electrodes (cathodes) was placed over the sacral foramina (S2 to S4). Anodes were applied on the back, right and left thigh, lower abdomen, and intra-anally. Stimulation using the novel method and current standard were performed at different phases of the experiments under electromyography of the autonomic innervated internal anal sphincter (IAS). KEY RESULTS: Transcutaneous stimulation induced increase of IAS activity could be observed in each animal under specific cathode-anode configurations. Out of 300 tested configurations, 18 exhibited a change in the IAS activity correlated with intentional autonomic nerve damage. The damage resulted in a significant decrease of the relative area under the curve of the IAS frequency spectrum (P<.001). Comparison of the IAS spectra under transcutaneous and direct stimulation revealed no significant difference (after rectal resection: median 5.99 µV•Hz vs 7.78 µV•Hz, P=.12; after intentional nerve damage: median -0.27 µV•Hz vs 3.35 µV•Hz, P=.29). CONCLUSIONS AND INFERENCES: Non-invasive selective transcutaneous sacral nerve stimulation could be used for verification of IAS innervation.

[Hybrid TAMIS total mesorectal excision. A new perspective in treatment of distal rectal cancer - Technique and results]. / Hybrid-TAMIS totale mesorektale Exzision. Neue Perspektive in der Behandlung des distalen Rektumkarzinoms - Technik und Ergebnisse.

BACKGROUND: Transanal minimally invasive surgery (TAMIS) represents a promising technique for total mesorectal excision (TME) with respect to radicalness and preservation of function. There are only few publications in the literature describing results in patients with distal rectal cancer. METHODS: Between May 2013 and March 2015, 24 selected patients with a rectal carcinoma < 6 cm from the anal verge underwent a laparoscopically assisted TAMIS TME (Hybrid-TAMIS TME) procedure. This prospective observational study was conducted to examine the safety of the technique and the quality of TME surgery in distal rectal cancer and to assess the short-term postoperative outcome. RESULTS: The median age of patients (18 male and 6 female) at the time of surgery was 57 years (range 35-77 years) and 7 patients (29 %) had a body mass index (BMI) > 30 kg/m(2). Specimen excision was carried out transanally in 19 patients. Pathological grading of TME specimens was good in 22 (92 %) and moderate in 2 cases. After neoadjuvant radiochemotherapy a complete pathological remission was identified in five patients. The median distal resection margin was 7 mm (range 2-30 mm), the median circumferential resection margin was 6 mm (range <1 mm-30 mm) and in 2 patients the tumor was ≤ 1 mm from the positive circumferential margin. A colonic reservoir was created in 19 patients (79 %) and no 30-day mortalities occurred. Morbidity was 29 %, including 1 anastomotic leak, 2 hematomas and 1 neurogenic bladder. CONCLUSION: Hybrid-TAMIS TME for distal rectal cancer is safe and can provide a sphincter-preserving high-quality TME in difficult cases. Studies with long-term follow-up assessing oncological and functional results are mandatory.

Is intraoperative neuromonitoring associated with better functional outcome in patients undergoing open TME? Results of a case-control study.

AIMS: Intraoperative neuromonitoring (IONM) aims to control nerve-sparing total mesorectal excision (TME) for rectal cancer in order to improve patients' functional outcome. This study was designed to compare the urogenital and anorectal functional outcome of TME with and without IONM of innervation to the bladder and the internal anal sphincter. METHODS: A consecutive series of 150 patients with primary rectal cancer were analysed. Fifteen match pairs with open TME and combined urogenital and anorectal functional assessment at follow up were established identical regarding gender, tumour site, tumour stage, neoadjuvant radiotherapy and type of surgery. Urogenital and anorectal function was evaluated prospectively on the basis of self-administered standardized questionnaires, measurement of residual urine volume and longterm-catheterization rate. RESULTS: Newly developed urinary dysfunction after surgery was reported by 1 of 15 patients in the IONM group and by 6 of 15 in the control group (p = 0.031). Postoperative residual urine volume was significantly higher in the control group. At follow up impaired anorectal function was present in 1 of 15 patients undergoing TME with IONM and in 6 of 15 without IONM (p = 0.031). The IONM group showed a trend towards a lower rate of sexual dysfunction after surgery. CONCLUSIONS: In this study TME with IONM was associated with significant lower rates of urinary and anorectal dysfunction. Prospective randomized trials are mandatory to evaluate the definite role of IONM in rectal cancer surgery.

Virtual reality laparoscopy: which potential trainee starts with a higher proficiency level?

PURPOSE: Minimally invasive surgery requires technical skills distinct from those used in conventional surgery. The aim of this prospective study was to identify personal characteristics that may predict the attainable proficiency level of first-time virtual reality laparoscopy (VRL) trainees. METHODS: Two hundred and seventy-nine consecutive undergraduate medical students without experience attended a standardized VRL training. Performance data of an abstract and a procedural task were correlated with possible predictive factors providing potential competence in VRL. RESULTS: Median global score requirement status was 86.7% (interquartile range (IQR) 75-93) for the abstract task and 74.4% (IQR 67-88) for the procedural task. Unadjusted analysis showed significant increase in the global score in both tasks for trainees who had a gaming console at home and frequently used it as well as for trainees who felt self-confident to assist in a laparoscopic operation. Multiple logistic regression analysis identified frequency of video gaming (often/frequently vs. rarely/not at all, odds ratio: abstract model 2.1 (95% confidence interval 1.2; 3.6), P = 0.009; virtual reality operation procedure 2.4 (95% confidence interval 1.3; 4.2), P = 0.003) as a predictive factor for VRL performance. CONCLUSION: Frequency of video gaming is associated with quality of first-time VRL performance. Video game experience may be used as trainee selection criteria for tailored concepts of VRL training programs.