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
Secondary identifying numbers	01EZ0726

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

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

Study information

Study design	Open controlled prospective clinical single centre study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	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
Study acronym	IKONA
Study objectives	Intermittent 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) studied	Intraoperative nerve monitoring
Intervention	Experimental 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 type	Procedure/Surgery
Primary outcome measure	Examination of functionality of continuous intraoperative monitoring of pelvic autonomic nerves during nerve-sparing mesorectal excision in rectal cancer patients
Secondary outcome measures	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
Overall study start date	01/03/2010
Completion date	01/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	35 participants
Key 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
Key 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
Date of first enrolment	01/03/2010
Date of final enrolment	01/03/2011

Locations

Countries of recruitment

Germany

Study participating centre

University Medical Centre of the Johannes Gutenberg University Mainz

Mainz
55131
Germany

Sponsor information

University Medical Centre of the Johannes Gutenberg University Mainz (Germany)
Hospital/treatment centre

Department of General and Abdominal Surgery
Langenbeckstr. 1
Mainz
55131
Germany

Website	http://www.uni-mainz.de/eng/
"ROR"	https://ror.org/00q1fsf04

Funders

Funder type

Government

German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan