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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017437
Enrollment
30
Registered
2020-03-31
Start date
2020-12-04
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal and urinary incontinence after surgery in the lesser pelvis/ low anterior resection. C20 K62 K57

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

Sponsors

Dr. Langer Medical GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients (men and women) with 1. rectum resection due to diverticulitis or carcinoma 2. resection rectopexies due to rectum prolaps or 3. rectum extirpation due to carcinoma, age > 18 years, full legal capacity, ASA 1-3

Exclusion criteria

Exclusion criteria: Absence of consent, pregnancy, patients with active implants (e.g. pacemaker or ICDs), patients suffering from epilepsy or severe cardiac arrhythmia, patients who participated an other clinical study according to MPG during the last 30 days, which could interfere with the current study, patients who are dependent on the sponsor or investigator

Design outcomes

Primary

MeasureTime frame
Localisation of pelvic nerves, due to direct nerve stimulation and measurement of the evoked contraction of the urinary baldder and rectum.

Secondary

MeasureTime frame
Correlation of patient survey (IPSS Score and LARS) about feacal and urinary incontinence (pre- and postoperative) and measurement data. Sensitivity and specificity of the method.

Countries

Germany

Contacts

Public ContactChristoph Marquardt

Klinikum Ludwigsburg

Christoph.Marquardt@rkh-kliniken.de071419966501

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026