Rectal Neoplasms Clinical Trial
Official title:
Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision
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.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | September 19, 2027 |
Est. primary completion date | September 19, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | University Hospital of Larissa | Larissa |
Lead Sponsor | Collaborator |
---|---|
Larissa University Hospital | General Hospital of Larissa, University of Thessaly |
Greece,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the quality of life of the patient at 3 months postoperatively, based on the SF-36 questionnaire | Change in the quality of life of the patient, at 3 months postoperatively, compared to the respective preoperative measurements, based on the Short Form 36 (SF-36) questionnaire SF-36: Short Form Survey Minimum Value: 0 Maximum Value: 100 Higher scores indicate a better outcome | Preoperatively, 3 months postoperatively | |
Secondary | Operative time | The total operative time will be recorded. Measurement unit: minutes | Intraoperative period | |
Secondary | Intraoperative bleeding | The total intraoperative blood loss volume will be recorded. Measurement unit: mL | Intraoperative period | |
Secondary | Postoperative discharge time | Postoperative time that the patient can be safely discharged. Measurement unit: hours. The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfil the Clinical Discharge Criteria. More specifically, the patient should meet the following : steady vital signs, be oriented, without nausea or vomiting, mobilized with a steady gait, without a significant bleeding | Maximum time frame 15 days postoperatively | |
Secondary | Postoperative complications | Occurrence of postoperative complications (based on Clavien-Dindo classification). If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 1 month postoperatively | |
Secondary | Negative resection margin | Occurrence of negative resection margin. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 1 month postoperatively | |
Secondary | Local recurrence | Occurrence of local recurrence. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 1 year postoperatively | |
Secondary | Bladder capacity | Urodynamic assessment. Evaluation of bladder capacity. Measurement unit: ml | Preoperatively and 2 months postoperatively | |
Secondary | Bladder compliance | Urodynamic assessment. Evaluation of bladder compliance. Measurement unit: ml/cm H2O | Preoperatively and 2 months postoperatively | |
Secondary | Detrusor pressure at maximum flow | Urodynamic assessment. Evaluation of detrusor pressure at maximum flow. Measurement unit: cm H2O | Preoperatively and 2 months postoperatively | |
Secondary | Maximum urinary flow rate | Urodynamic assessment. Evaluation of maximum urinary flow rate. Measurement unit: ml/s | Preoperatively and 2 months postoperatively | |
Secondary | Voiding volume | Urodynamic assessment. Evaluation of voiding volume. Measurement unit: ml | Preoperatively and 2 months postoperatively | |
Secondary | Post-void residual | Urodynamic assessment. Evaluation of post-void residual. Measurement unit: ml | Preoperatively and 2 months postoperatively | |
Secondary | Anal canal resting phase pressure | High-resolution Anorectal Manometry assessment. Evaluation of anal canal resting phase pressure. Measurement unit: mmHg | Preoperatively and 2 months postoperatively | |
Secondary | Sphincter zone length | High-resolution Anorectal Manometry assessment. Evaluation of sphincter zone length. Measurement unit: cm | Preoperatively and 2 months postoperatively | |
Secondary | Short squeeze test | High-resolution Anorectal Manometry assessment. Evaluation of short squeeze (5sec) pressure. Measurement unit: mmHg | Preoperatively and 2 months postoperatively | |
Secondary | Long squeeze test | High-resolution Anorectal Manometry assessment. Evaluation of long squeeze (30sec) pressure. Measurement unit: mmHg | Preoperatively and 2 months postoperatively | |
Secondary | Cough test | High-resolution Anorectal Manometry assessment. Evaluation of cough test (0 and 50 ml). If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | Preoperatively and 2 months postoperatively | |
Secondary | Push test | High-resolution Anorectal Manometry assessment. Evaluation of push test (0 and 50 ml). If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | Preoperatively and 2 months postoperatively | |
Secondary | RAIR test | High-resolution Anorectal Manometry assessment. Evaluation of rectoanal inhibitory reflex (RAIR) test (20 and 50 ml). If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | Preoperatively and 2 months postoperatively | |
Secondary | Difference in the quality of life of the patient, based on the SF-36 questionnaire | Difference in the quality of life of the patient, at 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the Short Form 36 (SF-36) questionnaire SF-36: Short Form Survey Minimum Value: 0 Maximum Value: 100 Higher scores indicate a better outcome | Preoperatively, 6, 12, 24 months postoperatively | |
Secondary | Difference in the erectile function of the patient, based on the IIEF questionnaire | Difference in the erectile function of the patient, at 3, 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the International Index of Erectile Function (IIEF) questionnaire IIEF: International Index of Erectile Function Minimum Value: 0 Maximum Value: 5 Higher scores indicate a better outcome | Preoperatively, 3, 6, 12, 24 months postoperatively | |
Secondary | Difference in the sexual function of the patient, based on the FSFI questionnaire | Difference in the sexual function of the patient, at 3, 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the Female Sexual Function Index (FSFI) questionnaire FSFI: Female Sexual Function Index Minimum Value: 2 Maximum Value: 36 Higher scores indicate a better outcome | Preoperatively, 3, 6, 12, 24 months postoperatively | |
Secondary | Difference in the prostate symptoms of the patient, based on the IPSS questionnaire | Difference in the prostate symptoms of the patient, at 3, 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the International Prostate Symptom Score (IPSS) questionnaire IPSS: International Prostate Symptom Score Minimum Value: 0 Maximum Value: 35 Higher scores indicate a worse outcome | Preoperatively, 3, 6, 12, 24 months postoperatively | |
Secondary | Difference in the low anterior syndrome symptoms of the patient, based on the LARS questionnaire | Difference in the low anterior syndrome symptoms of the patient, at 3, 6, 12, 24 months postoperatively, compared to the respective preoperative measurements, based on the Low Anterior Resection Syndrome (LARS) questionnaire LARS: Low Anterior Resection Syndrome Minimum Value: 0 Maximum Value: 42 Higher scores indicate a worse outcome | Preoperatively, 3, 6, 12, 24 months postoperatively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02537340 -
PET/MR for Staging Rectal Cancer Patients With and Without EMVI-MR
|
||
Recruiting |
NCT02565667 -
A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler
|
N/A | |
Not yet recruiting |
NCT02439086 -
Prediction of Response to Neoadjuvant Therapy in Rectal Cancer
|
N/A | |
Terminated |
NCT02538913 -
Exercise Training for Rectal Cancer Patients
|
N/A | |
Completed |
NCT02233374 -
Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET
|
N/A | |
Completed |
NCT00535041 -
Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA
|
N/A | |
Completed |
NCT00535652 -
Concentration of Ertapenem in Colorectal Tissue
|
Phase 4 | |
Recruiting |
NCT04095468 -
Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
|
||
Recruiting |
NCT06017583 -
Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer
|
Phase 3 | |
Recruiting |
NCT05689775 -
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
|
||
Recruiting |
NCT04006951 -
Development of a Clinical and Biological Database in Rectum Cancer
|
N/A | |
Recruiting |
NCT05068180 -
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
|
Phase 4 | |
Recruiting |
NCT03714490 -
MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer
|
Phase 2 | |
Recruiting |
NCT03325361 -
The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage
|
N/A | |
Completed |
NCT02252250 -
Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer
|
N/A | |
Completed |
NCT04455737 -
Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
|
||
Completed |
NCT01816607 -
Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
|
||
Completed |
NCT01721785 -
Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer
|
N/A | |
Active, not recruiting |
NCT01171300 -
Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients
|
N/A | |
Completed |
NCT01056913 -
NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
|
Phase 4 |