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

ABSTRACT: 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.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.This study will provide high quality evidence on the efficacy of pIONM aiming for improvement of functional outcome in rectal cancer patients undergoing TME.Clinicaltrials.gov: NCT01585727 . Registration date is 04/25/2012.

SUBMITTER: Kauff DW

PROVIDER: S-EPMC4875600 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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

Kauff D W DW Kronfeld K K Gorbulev S S Wachtlin D D Lang H H Kneist W W

BMC cancer 20160521

<h4>Background</h4>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.<h4>Methods/design</h4>NEUROS is a prospective two-arm ran ...[more]

PMID: 27209237

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Project description:The disruption of coordination between smooth muscle contraction in the bladder and the relaxation of the external urethral sphincter (EUS) striated muscle is a common issue in dysfunctional bladders. It is a significant challenge to overcome for neuromodulation approaches to restore bladder control. Bladder-sphincter dyssynergia leads to undesirably high bladder pressures, and poor voiding outcomes, which can pose life-threatening secondary complications. Mixed pelvic nerves are potential peripheral targets for stimulation to treat dysfunctional bladders, but typical electrical stimulation of pelvic nerves activates both the parasympathetic efferent pathway to excite the bladder, as well as the sensory afferent pathway that causes unwanted sphincter contractions. Thus, a novel pelvic nerve stimulation paradigm is required. In anesthetized female rats, we combined a low frequency (10 Hz) stimulation to evoke bladder contraction, and a more proximal 20 kHz stimulation of the pelvic nerve to block afferent activation, in order to produce micturition with reduced bladder-sphincter dyssynergia. Increasing the phase width of low frequency stimulation from 150 to 300 ?s alone was able to improve voiding outcome significantly. However, low frequency stimulation of pelvic nerves alone evoked short latency (19.9-20.5 ms) dyssynergic EUS responses, which were abolished with a non-reversible proximal central pelvic nerve cut. We demonstrated that a proximal 20 kHz stimulation of pelvic nerves generated brief onset effects at lower current amplitudes, and was able to either partially or fully block the short latency EUS responses depending on the ratio of the blocking to stimulation current. Our results indicate that ratios >10 increased the efficacy of blocking EUS contractions. Importantly, we also demonstrated for the first time that this combined low and high frequency stimulation approach produced graded control of the bladder, while reversibly blocking afferent signals that elicited dyssynergic EUS contractions, thus improving voiding by 40.5 ± 12.3%. Our findings support advancing pelvic nerves as a suitable neuromodulation target for treating bladder dysfunction, and demonstrate the feasibility of an alternative method to non-reversible nerve transection and sub-optimal intermittent stimulation methods to reduce dyssynergia.

Project description:BackgroundLaparoscopic total mesorectal excision (TME) for rectal cancer has been proved in various studies. The minimal invasive procedure is feasible and safe which was demonstrated in many studies. However, the results of prospective, randomized studies providing valuable evidence are still not available. Compared to conventional surgery, the laparoscopic technique has short-term advantages including less pain, shorter duration of postoperative ileus, less fatigue, better pulmonary function, and less blood loss (Leung et al., Lancet 363:1187-1192, 2004; Braga et al., Dis Colon Rectum 48:217-223, 2005; Jayne et al., J Clin Oncol 25:3061-3068, 2007; Agha et al., Surg Endosc 22:2229-2237, 2008).MethodsThe autonomic nerve sparing TME technique is the gold standard in rectal cancer resection even in conventional or laparoscopic procedure. With regard of the oncological dimension, the laparoscopic TME technique is not different compared to the open procedure. However, a standardized laparoscopic step-by-step procedure may simplify the operation and can reduce operation time.ResultsThere are no studies available which compare different types of TME procedures. Most surgeons start the operation left laterally mobilizing the sigmoid colon first. In the laparoscopic technique, we recommend the medial to lateral approach starting the operation at the right side of the rectum and sigmoid colon. A nerve sparing TME technique can be performed easier, and the identification of the left ureter may be simplified. After multiple workshops and extensive discussion with national and international experts, we developed a standardized laparoscopic "10 step TME procedure." Reviewing the results of laparoscopic TME the studies do not allow firm conclusions as to the questions of whether the safety and efficacy of laparoscopic TME is equal or superior to open TME (Breukink et al. 2006). Actually, we are waiting for large prospective randomized studies comparing laparoscopic TME with the traditional open procedure (Bonjer et al., Dan Med Bull 56:89-91, 2009).ConclusionLaparoscopic TME appears to have clinically measurable short-term advantages in patients with primary resectable rectal cancer based on evidence mainly from nonrandomized studies (Breukink et al. 5). In nearly all published studies, the efficacy and technical feasibility of laparoscopic surgery for rectal cancer could be demonstrated regarding perioperative morbidity and oncological outcome. A standardized laparoscopic TME technique can be strongly recommended.

Dataset Information

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

Publications

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

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