Rectal CancerNEUROSNCT01585727
Intraoperative Monitoring of the Pelvic Autonomic Nerves
A study testing TME and Neuromonitoring in people with Rectal Cancer, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
One of the major problems of rectal cancer surgery is pelvic autonomic nerve damage, which is the main cause of urogenital dysfunction influencing postoperative quality of life. Costs for diagnostics and treatment of short and long-term urogenital dysfunction are immense. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- TME and Neuromonitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- histologically confirmed carcinoma of the rectum (≤ 16 cm from anal verge)
- fit for radical surgery
- total mesorectal excision
- age 18-80 years
Who cannot join
- history of operation of the urinary tract (e.g. prostatectomy)
- pacemaker
- emergency operation
- multivisceral resection in the pelvis
- partial mesorectal excision
- eligibility for local excision (TEM, intestinal wall resection)
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- ongoing infection or sepsis
- severe untreated physical or mental impairment
- pregnancy or breastfeeding
- women of childbearing potential who are not using a highly effective birth control method
- missing preoperative data on urogenital or anorectal function
- simultaneous participation in another clinical trial
- previous participation in this clinical trial
- lack of cooperation with the trial procedure
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of General and Visceral Surgery, University Medical Center Mainz
Mainz
About this study
Official title: Continuous Intraoperative Monitoring of the Pelvic Autonomic Nerves During Total Mesorectal Excision (TME) for the Prevention of Urogenital and Anorectal Dysfunction in Patients With Rectal Cancer.
One of the major problems of rectal cancer surgery is pelvic autonomic nerve damage, which is the main cause of urogenital dysfunction influencing postoperative quality of life. Costs for diagnostics and treatment of short and long-term urogenital dysfunction are immense. Varying degrees of urogenital dysfunction are found in up to 32% and 55% of patients with rectal cancer despite potentially nerve-sparing total mesorectal excision (TME).
The study will examine the impact of a newly developed continuous monitoring device for preservation of urogenital function in patients with TME for rectal cancer. 188 patients will be included in the prospective, randomized, single-blind, parallel group multi-centre trial including two arms (TME with and without intraoperative continuous monitoring of pelvic autonomic nerves). The primary efficacy endpoint is the change in urinary function measured by International Prostate Function Score (IPSS) 12 months after surgery. Genital functions measured as secondary endpoints. The application of the continuous intraoperative neuromonitoring device could enhance the objective intraoperative confirmation of pelvic nerve sparing surgery. The investigators hypothesis is that the use of his device minimizes the risk of postoperative urogenital dysfunction in patients with TME for rectal cancer. An enormous reduction of treatment costs is to be expected.
- Conditions
- Rectal Cancer
- Being tested
- TME, Neuromonitoring
- Keywords
- Rectal cancer, total mesorectal excision, pelvic autonomic nerve preservation, neurostimulation, urogenital function, quality of life
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMEProcedure or surgery
Total mesorectal excision
TMEProcedure or surgery
Total mesorectal excision
NeuromonitoringProcedure or surgery
Intraoperative neuromonitoring of pelvic autonomic nerves.
| Study group | Role | What they receive |
|---|---|---|
| TME with neuromonitoring | Experimental | Total mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves. Receives: Procedure: TME; Procedure: Neuromonitoring |
| TME without neuromontoring | Active comparator | Total mesorectal excision without intraoperative neuromonitoring of pelvic autonomic nerves. Receives: Procedure: TME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urogenital function
Increase of IPSS score by at least 5 points observed 12 months after surgery compared to the preoperative IPSS score per patient
Measured: 12 months
Secondary outcomes (6)
Sexual function (females)
Reduction of FSFI score by at least 8 points 12 months after surgery compared to the preoperative FSFI score per patient.
Measured: 12 months
Sexual function (males)
Reduction of IIEF score by at least 15 points 12 months after surgery compared to the preoperative IIEF score per patient.
Measured: 12 months
Adverse events
Occurrence of adverse events.
Measured: 12 months
Oncological safety
Rates of pCRM-positive specimen (distance of tumour from circumferential resection margin (CRM) ≤ 1mm).
Measured: 12 months
Quality of mesorectal excision
Macroscopic assessment of the resection specimen.
Measured: 1 day after the surgery
Fecal incontinence
Evaluation of fecal incontinence using the Wexner-Vaizey score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Werner Kneist, Johannes Gutenberg University Mainz
- Investigators
- Werner Kneist, Univ.-Prof., Principal investigator, Department of Visceral and Abdominal Surgery, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585727
- Sponsor's protocol ID
- 2007-012
- Other IDs
- KN 930/1-1
- Acronym
- NEUROS
- Status last verified
- Feb 2019
- First submitted
- 25 Apr 2012
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kauff DW, Kronfeld K, Gorbulev S, Wachtlin D, Lang H, Kneist W. Continuous intraoperative monitoring of pelvic autonomic nerves during TME to prevent urogenital and anorectal dysfunction in rectal cancer patients (NEUROS): a randomized controlled trial. BMC Cancer. 2016 May 21;16:323. doi: 10.1186/s12885-016-2348-4.
PubMed 27209237
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Intraoperative Monitoring of the Pelvic Autonomic Nerves During Total Mesorectal Excision (TME) for the Prevention of Urogenital and Anorectal Dysfunction in Patients With Rectal Cancer.
- ClinicalTrials.gov ID
- NCT01585727
- Acronym / sponsor ID
- NEUROS / 2007-012
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, total mesorectal excision, pelvic autonomic nerve preservation, neurostimulation, urogenital function, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the major problems of rectal cancer surgery is pelvic autonomic nerve damage, which is the main cause of urogenital dysfunction influencing postoperative quality of life. Costs for diagnostics and treatment of short and long-term urogenital dysfunction are immense. Varying degrees of urogenital dysfunction are found in up to 32% and 55% of patients with rectal cancer despite potentially nerve-sparing total mesorectal excision (TME).
The study will examine the impact of a newly developed continuous monitoring device for preservation of urogenital function in patients with TME for rectal cancer. 188 patients will be included in the prospective, randomized, single-blind, parallel group multi-centre trial including two arms (TME with and without intraoperative continuous monitoring of pelvic autonomic nerves). The primary efficacy endpoint is the change in urinary function measured by International Prostate Function Score (IPSS) 12 months after surgery. Genital functions measured as secondary endpoints. The application of the continuous intraoperative neuromonitoring device could enhance the objective intraoperative confirmation of pelvic nerve sparing surgery. The investigators hypothesis is that the use of his device minimizes the risk of postoperative urogenital dysfunction in patients with TME for rectal cancer. An enormous reduction of treatment costs is to be expected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TME with neuromonitoring | Experimental | Procedure: TME, Procedure: NeuromonitoringTotal mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves. |
| TME without neuromontoring | Active comparator | Procedure: TMETotal mesorectal excision without intraoperative neuromonitoring of pelvic autonomic nerves. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- informed consent
- histologically confirmed carcinoma of the rectum (≤ 16 cm from anal verge)
- fit for radical surgery
- total mesorectal excision
- age 18-80 years
Key exclusion criteria (14 listed)
- history of operation of the urinary tract (e.g. prostatectomy)
- pacemaker
- emergency operation
- multivisceral resection in the pelvis
- partial mesorectal excision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMETotal mesorectal excision | Procedure or surgery | TME with neuromonitoring |
| TMETotal mesorectal excision | Procedure or surgery | TME without neuromontoring |
| NeuromonitoringIntraoperative neuromonitoring of pelvic autonomic nerves. | Procedure or surgery | TME with neuromonitoring |
Primary outcome
Urogenital function
Time frame: 12 months
Increase of IPSS score by at least 5 points observed 12 months after surgery compared to the preoperative IPSS score per patient
6 secondary outcomes
Sexual function (females)
Time frame: 12 months
Sexual function (males)
Time frame: 12 months
Adverse events
Time frame: 12 months
Oncological safety
Time frame: 12 months
Quality of mesorectal excision
Time frame: 1 day after the surgery
Fecal incontinence
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Derived from this study: PubMed 27209237Kauff DW, Kronfeld K, Gorbulev S, Wachtlin D, Lang H, Kneist W. Continuous intraoperative monitoring of pelvic autonomic nerves during TME to prevent urogenital and anorectal dysfunction in rectal cancer patients (NEUROS): a randomized controlled trial. BMC Cancer. 2016 May 21;16:323. doi: 10.1186/s12885-016-2348-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Kneist, Univ.-Prof. principal investigator
Department of Visceral and Abdominal Surgery, University Medical Center Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TME and Neuromonitoring in people with Rectal Cancer, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urogenital function (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01585727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.