Clinical trial · Interventional
Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision
NCT04949646CI-TRIAL-00094503recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research protocol is the evaluation of the improvement of the anorectal and urogenital urinary function, alongside the postoperative quality of life after the application of pIONM in patients submitted to TME for rectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pelvic Intraoperative Neuromonitoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- pIONM
- description
- In the experimental group pIONM will be performed intraoperatively. For the implementation of pIONM, a special device, that allows simultaneous monitoring of sphincter signals and bladder manometry, will be introduced. This device will employ the placement of a bipolar electrode in the internal and external anal sphincter. Moreover, another electrode will be placed on the surrounding tissues. For bladder manometry, the catheter will be connected to the pressure sensor, and subsequently to the pIONM monitor. Intraoperatively, depending on the approach (open or laparoscopic), the respective bipolar stimulator will be used. Prior to the initiation of pIONM, urinary bladder will be drained and filled with 200 ml R/L. The pIONM parameters will be the following: 1-25 milliampere current, 30 Hz frequency and 200 μs monophasic pulses.
- interventionNames
- Other: Pelvic Intraoperative Neuromonitoring
- type
- NO_INTERVENTION
- label
- Control
- description
- In the control group pIONM will not be performed intraoperatively
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed rectal cancer * Surgical resection with TME * \<90 years old * Signed informed consent Exclusion Criteria: * Emergency operation * Presence of pacemaker * Partial mesorectal excision * Sepsis or systematic infection * Physical or mental impairment * Pregnancy or nursing * Insufficient preoperative data for the urogenital/ anorectal function * Lack of compliance with the research process
References
Publications (33)
- BACKGROUNDKauff DW, Kempski O, Koch KP, Huppert S, Hoffmann KP, Lang H, Kneist W. Continuous intraoperative monitoring of autonomic nerves during low anterior rectal resection: an innovative approach for observation of functional nerve integrity in pelvic surgery. Langenbecks Arch Surg. 2012 Jun;397(5):787-92. doi: 10.1007/s00423-011-0900-x. Epub 2012 Feb 15. PMID 22350611
- BACKGROUNDKauff DW, Lang H, Kneist W. Risk Factor Analysis for Newly Developed Urogenital Dysfunction after Total Mesorectal Excision and Impact of Pelvic Intraoperative Neuromonitoring-a Prospective 2-Year Follow-Up Study. J Gastrointest Surg. 2017 Jun;21(6):1038-1047. doi: 10.1007/s11605-017-3409-y. Epub 2017 Apr 4. PMID 28378317
- BACKGROUNDWallner C, Lange MM, Bonsing BA, Maas CP, Wallace CN, Dabhoiwala NF, Rutten HJ, Lamers WH, Deruiter MC, van de Velde CJ; Cooperative Clinical Investigators of the Dutch Total Mesorectal Excision Trial. Causes of fecal and urinary incontinence after total mesorectal excision for rectal cancer based on cadaveric surgery: a study from the Cooperative Clinical Investigators of the Dutch total mesorectal excision trial. J Clin Oncol. 2008 Sep 20;26(27):4466-72. doi: 10.1200/JCO.2008.17.3062. PMID 18802159
- BACKGROUNDKauff 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. PMID 27209237
- BACKGROUNDDelacroix SE Jr, Winters JC. Voiding dysfunction after pelvic colorectal surgery. Clin Colon Rectal Surg. 2010 Jun;23(2):119-27. doi: 10.1055/s-0030-1254299. PMID 21629630
- BACKGROUNDKneist W, Kauff DW, Rahimi Nedjat RK, Rink AD, Heimann A, Somerlik K, Koch KP, Doerge T, Lang H. Intraoperative pelvic nerve stimulation performed under continuous electromyography of the internal anal sphincter. Int J Colorectal Dis. 2010 Nov;25(11):1325-31. doi: 10.1007/s00384-010-1015-5. Epub 2010 Jul 27.