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Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04949646

Recruitment Status : Recruiting

First Posted : July 2, 2021

Last Update Posted : March 13, 2024

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

General Hospital of Larissa

University of Thessaly

Information provided by (Responsible Party):

Perivoliotis Konstantinos, Larissa University Hospital

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Recruiting
Estimated Primary Completion Date :	September 19, 2026
Estimated Study Completion Date :	September 19, 2027

Publications:

Kauff 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.

Kauff 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.

Wallner 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.

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.

Delacroix 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.

Kneist 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.

Moszkowski T, Kauff DW, Wegner C, Ruff R, Somerlik-Fuchs KH, Kruger TB, Augustyniak P, Hoffmann KP, Kneist W. Extracorporeal Stimulation of Sacral Nerve Roots for Observation of Pelvic Autonomic Nerve Integrity: Description of a Novel Methodological Setup. IEEE Trans Biomed Eng. 2018 Mar;65(3):550-555. doi: 10.1109/TBME.2017.2703951. Epub 2017 May 12.

Kauff DW, Koch KP, Somerlik KH, Heimann A, Hoffmann KP, Lang H, Kneist W. Online signal processing of internal anal sphincter activity during pelvic autonomic nerve stimulation: a new method to improve the reliability of intra-operative neuromonitoring signals. Colorectal Dis. 2011 Dec;13(12):1422-7. doi: 10.1111/j.1463-1318.2010.02510.x.

Kauff DW, Moszkowski T, Wegner C, Heimann A, Hoffmann KP, Kruger TB, Lang H, Kneist W. Transcutaneous sacral nerve stimulation for intraoperative verification of internal anal sphincter innervation. Neurogastroenterol Motil. 2017 Dec;29(12). doi: 10.1111/nmo.13140. Epub 2017 Jul 6.

Schiemer JF, Juo YY, Sanaiha Y, Lin AY, Kazanjian K, Lang H, Kneist W. Application of a newly designed microfork probe for robotic-guided pelvic intraoperative neuromapping. J Minim Access Surg. 2019 Apr-Jun;15(2):182-183. doi: 10.4103/jmas.JMAS_12_18.

Kauff DW, Koch KP, Somerlik KH, Hoffmann KP, Lang H, Kneist W. Evaluation of two-dimensional intraoperative neuromonitoring for predicting urinary and anorectal function after rectal cancer surgery. Int J Colorectal Dis. 2013 May;28(5):659-64. doi: 10.1007/s00384-013-1662-4. Epub 2013 Feb 26.

Grade M, Beham AW, Schuler P, Kneist W, Ghadimi BM. Pelvic intraoperative neuromonitoring during robotic-assisted low anterior resection for rectal cancer. J Robot Surg. 2016 Jun;10(2):157-60. doi: 10.1007/s11701-015-0556-6. Epub 2015 Dec 24.

Kneist W, Kauff DW, Naumann G, Lang H. Resection rectopexy--laparoscopic neuromapping reveals neurogenic pathways to the lower segment of the rectum: preliminary results. Langenbecks Arch Surg. 2013 Apr;398(4):565-70. doi: 10.1007/s00423-013-1064-7. Epub 2013 Feb 23.

Schiemer JF, Zimniak L, Hadzijusufovic E, Lang H, Kneist W. Novel multi-image view for neuromapping meets the needs of the robotic surgeon. Tech Coloproctol. 2018 Jun;22(6):445-448. doi: 10.1007/s10151-018-1804-3. Epub 2018 Jun 4.

Zhou MW, Huang XY, Chen ZY, Li ZY, Zhou YM, Yang Y, Wang ZH, Xiang JB, Gu XD. Intraoperative monitoring of pelvic autonomic nerves during laparoscopic low anterior resection of rectal cancer. Cancer Manag Res. 2018 Dec 31;11:411-417. doi: 10.2147/CMAR.S182181. eCollection 2019.

Fang JF, Wei B, Zheng ZH, Chen TF, Huang Y, Huang JL, Lei PR, Wei HB. Effect of intra-operative autonomic nerve stimulation on pelvic nerve preservation during radical laparoscopic proctectomy. Colorectal Dis. 2015 Dec;17(12):O268-76. doi: 10.1111/codi.13115.

Kneist W, Junginger T. Validity of pelvic autonomic nerve stimulation with intraoperative monitoring of bladder function following total mesorectal excision for rectal cancer. Dis Colon Rectum. 2005 Feb;48(2):262-9. doi: 10.1007/s10350-004-0797-3.

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

Rosier PFWM, Schaefer W, Lose G, Goldman HB, Guralnick M, Eustice S, Dickinson T, Hashim H. International Continence Society Good Urodynamic Practices and Terms 2016: Urodynamics, uroflowmetry, cystometry, and pressure-flow study. Neurourol Urodyn. 2017 Jun;36(5):1243-1260. doi: 10.1002/nau.23124. Epub 2016 Dec 5.

Pappa E, Kontodimopoulos N, Niakas D. Validating and norming of the Greek SF-36 Health Survey. Qual Life Res. 2005 Jun;14(5):1433-8. doi: 10.1007/s11136-004-6014-y.

Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.

Mourikis I, Antoniou M, Matsouka E, Vousoura E, Tzavara C, Ekizoglou C, Papadimitriou GN, Vaidakis N, Zervas IM. Anxiety and depression among Greek men with primary erectile dysfunction and premature ejaculation. Ann Gen Psychiatry. 2015 Oct 29;14:34. doi: 10.1186/s12991-015-0074-y. eCollection 2015.

Stephenson KR, Toorabally N, Lyons L, M Meston C. Further Validation of the Female Sexual Function Index: Specificity and Associations With Clinical Interview Data. J Sex Marital Ther. 2016 Jul 3;42(5):448-61. doi: 10.1080/0092623X.2015.1061078. Epub 2015 Jun 22.

Zachariou A, Filiponi M, Kirana PS. Translation and validation of the Greek version of the female sexual function index questionnaire. Int J Impot Res. 2017 Jul;29(4):171-174. doi: 10.1038/ijir.2017.18. Epub 2017 Apr 20.

Bayoud Y, de la Taille A, Ouzzane A, Ploussard G, Allory Y, Yiou R, Vordos D, Hoznek A, Salomon L. International Prostate Symptom Score is a predictive factor of lower urinary tract symptoms after radical prostatectomy. Int J Urol. 2015 Mar;22(3):283-7. doi: 10.1111/iju.12681. Epub 2015 Jan 22.

Konstantinidis C, Samarinas M, Andreadakis S, Xanthis S, Skriapas K. Lower urinary tract symptoms associated with benign prostatic hyperplasia: combined treatment with fesoterodine fumarate extended-release and tamsulosin--a prospective study. Urol Int. 2013;90(2):156-60. doi: 10.1159/000345050. Epub 2012 Dec 5.

Juul T, Ahlberg M, Biondo S, Emmertsen KJ, Espin E, Jimenez LM, Matzel KE, Palmer G, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. International validation of the low anterior resection syndrome score. Ann Surg. 2014 Apr;259(4):728-34. doi: 10.1097/SLA.0b013e31828fac0b.

Liapi A, Mavrantonis C, Lazaridis P, Kourkouni E, Zevlas A, Zografos G, Theodoropoulos G. Validation and comparative assessment of low anterior resection syndrome questionnaires in Greek rectal cancer patients. Ann Gastroenterol. 2019 Mar-Apr;32(2):185-192. doi: 10.20524/aog.2019.0350. Epub 2019 Jan 15.

O'Leary DP, Fide CJ, Foy C, Lucarotti ME. Quality of life after low anterior resection with total mesorectal excision and temporary loop ileostomy for rectal carcinoma. Br J Surg. 2001 Sep;88(9):1216-20. doi: 10.1046/j.0007-1323.2001.01862.x.

MERCURY Study Group. Diagnostic accuracy of preoperative magnetic resonance imaging in predicting curative resection of rectal cancer: prospective observational study. BMJ. 2006 Oct 14;333(7572):779. doi: 10.1136/bmj.38937.646400.55. Epub 2006 Sep 19.

Carrington EV, Heinrich H, Knowles CH, Fox M, Rao S, Altomare DF, Bharucha AE, Burgell R, Chey WD, Chiarioni G, Dinning P, Emmanuel A, Farouk R, Felt-Bersma RJF, Jung KW, Lembo A, Malcolm A, Mittal RK, Mion F, Myung SJ, O'Connell PR, Pehl C, Remes-Troche JM, Reveille RM, Vaizey CJ, Vitton V, Whitehead WE, Wong RK, Scott SM; All members of the International Anorectal Physiology Working Group. The international anorectal physiology working group (IAPWG) recommendations: Standardized testing protocol and the London classification for disorders of anorectal function. Neurogastroenterol Motil. 2020 Jan;32(1):e13679. doi: 10.1111/nmo.13679. Epub 2019 Aug 12.

Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth. 1995 Sep;7(6):500-6. doi: 10.1016/0952-8180(95)00130-a.

Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.