Joint neuromonitoring project: Continuous intraoperative neuromonitoring as a microtechnological navigation instrument for surgical procedures with subproject of medical and scientific investigations in the minor pelvis

Joint neuromonitoring project: Continuous intraoperative neuromonitoring as a microtechnological navigation instrument for surgical procedures with subproject of medical and scientific investigations in the minor pelvis: An open label, prospective, controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN06042867

Enrollment

Registered

2010-04-09

Start date

2010-03-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Intraoperative nerve monitoring Surgery Malignant neoplasm of rectum

Interventions

Experimental intervention: Nerve-sparing mesorectal excision with both intermittent and continuous intraoperative monitoring of pelvic autonomic nerves in patients with rectal cancer. Prospective eva

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed carcinoma of the rectum 2. Curative or palliative rectal resection, abdomino-perineal rectal extirpation, multivisceral resection 3. Male or female, aged greater than or equal to 18 years 4. Signed declaration of consent

Exclusion criteria

Exclusion criteria: 1. Emergency operation 2. Transanal Endoscopic Microsurgery (TEM) 3. Pacemaker 4. General contraindications for operation 5. Missing data on urogenital and anorectal function 6. Pregnancy and breastfeeding

Design outcomes

Primary

Measure	Time frame
Examination of functionality of continuous intraoperative monitoring of pelvic autonomic nerves during nerve-sparing mesorectal excision in rectal cancer patients	—

Secondary

Measure	Time frame
1. Examination of functionality of selective identification and intermittent intraoperative monitoring of pelvic autonomic nerves during nerve-sparing mesorectal excision in rectal cancer patients 2. Comparison of neurostimulation results with the observed clinical data 2.1. Preoperative data: 2.1.1. Anamnesis 2.1.2. Indication for operation 2.1.3. Clinical staging 2.1.4. Standardised questionnaires: 2.1.4.1. International Prostate Symptom Score (IPSS) 2.1.4.2. Quality of Life (QoL) 2.1.4.3. Cleveland Clinic Incontinence Score (CCIS) 2.1.4.4. Memorial Sloan-Kettering Cancer Center (MSKCC) assessment for anal continence 2.1.4.5. International Index of Erectile Function (IIEF) 2.1.4.6. Female Sexual Function Index (FSFI) 2.1.5. Sonographic assessment of the residual volume 2.2. Intraoperative data: 2.2.1. Macroscopic assessment of pelvic autonomic nerve preservation 2.2.2. Intraoperative complications 2.2.3. Assessment of stimulation probes 2.3. Postoperative data: 2.3.1. Pathological staging 2.3.2. Standardised questionnaires (IPSS, Qol, CCIS, MSKCC, IIEF, FSFI) 2.3.3. Date of removal of suprapubic or indwelling catheter 2.3.4. Need for recatheterisation 2.3.5. Sonographic assessment of the residual volume 2.3.6. Postoperative complications	—

Measure

Time frame

1. Examination of functionality of selective identification and intermittent intraoperative monitoring of pelvic autonomic nerves during nerve-sparing mesorectal excision in rectal cancer patients 2. Comparison of neurostimulation results with the observed clinical data 2.1. Preoperative data: 2.1.1. Anamnesis 2.1.2. Indication for operation 2.1.3. Clinical staging 2.1.4. Standardised questionnaires: 2.1.4.1. International Prostate Symptom Score (IPSS) 2.1.4.2. Quality of Life (QoL) 2.1.4.3. Cleveland Clinic Incontinence Score (CCIS) 2.1.4.4. Memorial Sloan-Kettering Cancer Center (MSKCC) assessment for anal continence 2.1.4.5. International Index of Erectile Function (IIEF) 2.1.4.6. Female Sexual Function Index (FSFI) 2.1.5. Sonographic assessment of the residual volume 2.2. Intraoperative data: 2.2.1. Macroscopic assessment of pelvic autonomic nerve preservation 2.2.2. Intraoperative complications 2.2.3. Assessment of stimulation probes 2.3. Postoperative data: 2.3.1. Pathological staging 2.3.2. Standardised questionnaires (IPSS, Qol, CCIS, MSKCC, IIEF, FSFI) 2.3.3. Date of removal of suprapubic or indwelling catheter 2.3.4. Need for recatheterisation 2.3.5. Sonographic assessment of the residual volume 2.3.6. Postoperative complications

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026