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

Not Applicable

• Conditions: Fecal and urinary incontinence after surgery in the lesser pelvis/ low anterior resection.; C20; K62; K57; Malignant neoplasm of rectum; Other diseases of anus and rectum; Diverticular disease of intestine

• Registration Number: DRKS00017437
• Lead Sponsor: Dr. Langer Medical GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-31
• Results First Posted: 2021-11-28
• Study Completion: 2023-11-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocalisation of pelvic nerves, due to direct nerve stimulation and measurement of the evoked contraction of the urinary baldder and rectum.<br>

Secondary Outcome Measures

Name	Time	Method
Correlation of patient survey (IPSS Score and LARS) about feacal and urinary incontinence (pre- and postoperative) and measurement data.<br>Sensitivity and specificity of the method.