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Intraoperative neuromonitoring for identification and monitoring of nerve tissue of the pelvic floor

ABSTRACT: Interventions: Group 1: Intraoperative neuromonitoring of pelvic nerves, including patients with indicated low anterior resections (e.g. for treatment of rectum carcinoma). Step 1: Determination of the preoperative continence incl. the LARS and IPSS Score, as well as residual urine, <7d before surgery Step 2: Intraoperative pelvic neuromonitoring with neuromonitor AVALANCHE NeuroNeB (Dr. Langer Medical GmbH) for the duration of the surgery (approx. 4-8 h, depending on the surgery). Neuromonitoring is performed according to the principle of direct electrical stimulation of pelvic nerves in the surgical area with a hand probe (to locate and identificate the nerves) and recording of the contraction of the rectum and urinary bladder with electrodes located in both organs. The goal is to identificate the nerves to preserve them from damage during the ongoing surgical preperation. Step 3. Determination of the postoperative continence incl. the LARS and IPSS Score, as well as residual urine, <7d after surgery, afterwards every 3 month, one year in maximum. Primary outcome(s): Localisation of pelvic nerves, due to direct nerve stimulation and measurement of the evoked contraction of the urinary baldder and rectum. Study Design: Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: prevention

DISEASE(S): Malignant Neoplasm Of Rectum,Diverticular Disease Of Intestine,Fecal And Urinary Incontinence After Surgery In The Lesser Pelvis/ Low Anterior Resection,Other Diseases Of Anus And Rectum

PROVIDER: 2435684 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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