Condition category
Surgery
Date applied
04/03/2010
Date assigned
09/04/2010
Last edited
09/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Werner Kneist

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01EZ0726

Study information

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

Acronym

IKONA

Study hypothesis

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

Local ethics committee (Ethik-Kommission der Landesärztekammer Rheinland-Pfalz) approved on the 14th October 2009 (ref: 837.473.08 [6470])

Study design

Open controlled prospective clinical single centre study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/03/2010

Overall trial end date

01/03/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

35 participants

Participant 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

Recruitment start date

01/03/2010

Recruitment end date

01/03/2011

Locations

Countries of recruitment

Germany

Trial participating centre

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

Sponsor information

Organisation

University Medical Centre of the Johannes Gutenberg University Mainz (Germany)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.uni-mainz.de/eng/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes