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

ISRCTN ISRCTN06042867
DOI https://doi.org/10.1186/ISRCTN06042867
Protocol serial number 01EZ0726
Sponsor University Medical Centre of the Johannes Gutenberg University Mainz (Germany)
Funder German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Submission date
04/03/2010
Registration date
09/04/2010
Last edited
09/04/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Werner Kneist
Scientific

University Medical Centre of the Johannes Gutenberg University Mainz
Department of General and Abdominal Surgery
Langenbeckstr.1
Mainz
55131
Germany

+49 (0)6131 17 7291
kneist@ach.klinik.uni-mainz.de

Study information

Primary study designInterventional
Study designOpen controlled prospective clinical single centre study
Secondary study designNon randomised controlled trial
Study type Participant information sheet
Scientific titleJoint 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
Study acronymIKONA
Study objectivesIntermittent and continuous intraoperative monitoring of pelvic autonomic nerves during
nerve-sparing mesorectal excision minimisess postoperative complications such as urogenital and anorectal dysfunction.
Ethics approval(s)Local ethics committee (Ethik-Kommission der Landesärztekammer Rheinland-Pfalz) approved on the 14th October 2009 (ref: 837.473.08 [6470])
Health condition(s) or problem(s) studiedIntraoperative nerve monitoring
InterventionExperimental intervention:
Nerve-sparing mesorectal excision with both intermittent and continuous intraoperative monitoring of pelvic autonomic nerves in patients with rectal cancer. Prospective evaluation of urogenital and anorectal function postoperatively. The inferior hypogastric plexus and pelvic splanchnic nerves are identified and electrodes are placed to ensure the continuous subliminal application of electricity. The stimulation response is assessed based on electromyogram (EMG) signals from the internal anal sphincter and manometry of the urinary bladder.

Duration of intervention per patient:
Neuromonitoring is associated with an expected extension in operative time of approximately 20 to 40 minutes. The total duration of follow up will be approximately 3 weeks.
Intervention typeProcedure/Surgery
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date01/03/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration35
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/03/2010
Date of final enrolment01/03/2011

Locations

Countries of recruitment

  • Germany

Study participating centre

University Medical Centre of the Johannes Gutenberg University Mainz
Mainz
55131
Germany

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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