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Departure of the two main investigators
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To evaluate the feasibility and precision of stereotaxic navigation in laparoscopic surgery for colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREOP | No Intervention | Navigation without intraoperative acquisition of images: Use of conventional preoperative images (CT-MRI) to establish intraoperative navigation. | |
| PEROP | Experimental | Navigation with intraoperative acquisition of images: Intraoperative acquisition (robotic c-Arm) of images to establish intraoperative navigation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative acquisition (robotic c-Arm) of images | Other | Conventional laparoscopic colorectal oncologic resection is performed. During the procedure, the operator will identify previously defined anatomical landmarks, point them with an instrument tracked by the navigation system and the accuracy of the stereotactic navigation system will be calculated by comparing the "surgical" anatomical point and its correspondent on the images of the navigation platform. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Surgical stereotactic navigation defined as the distance, in millimetres, between the position of the surgical landmark and the position determined by the navigation system | Measurement of "accuracy" of surgical navigation defined as the distance measured between the position of "surgical" previously defined anatomical landmarks, pointed with a surgical instrument tracked by the navigation system, and corresponding location of the instrument in the navigation image. A distance equal to or less than 4 mm between the two locations will be considered as an optimum accuracy. | up to 7 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison, in millimeters, of the surgical navigation "accuracy" (as defined in the primary outcome) with or without intraoperative images acquisition | Usefulness of intraoperative images acquisition for the registration process of the navigation system by comparing accuracy of surgical navigation (in mm) with or without intraoperative images acquisition | up to 7 days post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier Mutter, MD, PhD | Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Digestive et Endocrinienne, NHC | Strasbourg | 67 091 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27766137 | Background | Marley AR, Nan H. Epidemiology of colorectal cancer. Int J Mol Epidemiol Genet. 2016 Sep 30;7(3):105-114. eCollection 2016. | |
| 26818619 | Background | Arnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27. |
| Label | URL |
|---|---|
| Image-guided navigation surgery for pelvic malignancies using electromagnetic tracking - Proceedings of the SPIE | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| Difference, in millimetres, between the alignment of the geometric position of the markers in the image space and the actual physical space for stereotaxic navigation | Measurement of "registration error" during surgical navigation defined as the difference between the alignment of the geometric position of the markers in the image space and the actual physical space, with or without intraoperative images acquisition. An error of 2 mm during the recording process will be considered as the optimal parameter | up to 7 days post procedure |
| Measurement of the overall operating time (in minutes) with and without intraoperative images acquisition | Evaluation of the impact of the introduction of surgical navigation on the operating time. The measurement of the overall operating time (expressed in minutes), associated with surgical navigation | up to 30 days post procedure |
| Measurement of the level of radiation exposure to ionizing factors with and without intraoperative images acquisition | Evaluation of the impact of the introduction of surgical navigation on the exposure of the patient to ionizing radiation, measured with Dose Length Product (DLP) and expressed in mGy * cm | up to 30 days post procedure |
| Number of intra and/or postoperative complication | Evaluation of the impact of the introduction of surgical navigation on the incidence of intra- and / or postoperative complications associated with surgical navigation | up to 30 days post procedure |
| 27721923 | Background | Biondi A, Vacante M, Ambrosino I, Cristaldi E, Pietrapertosa G, Basile F. Role of surgery for colorectal cancer in the elderly. World J Gastrointest Surg. 2016 Sep 27;8(9):606-613. doi: 10.4240/wjgs.v8.i9.606. |
| 16538219 | Background | Simmonds PC, Primrose JN, Colquitt JL, Garden OJ, Poston GJ, Rees M. Surgical resection of hepatic metastases from colorectal cancer: a systematic review of published studies. Br J Cancer. 2006 Apr 10;94(7):982-99. doi: 10.1038/sj.bjc.6603033. |
| 16945773 | Background | Rullier E, Sebag-Montefiore D. Sphincter saving is the primary objective for local treatment of cancer of the lower rectum. Lancet Oncol. 2006 Sep;7(9):775-7. doi: 10.1016/S1470-2045(06)70863-4. No abstract available. |
| 26217114 | Background | Orsini RG, Wiggers T, DeRuiter MC, Quirke P, Beets-Tan RG, van de Velde CJ, Rutten HJ. The modern anatomical surgical approach to localised rectal cancer. EJC Suppl. 2013 Sep;11(2):60-71. doi: 10.1016/j.ejcsup.2013.07.033. No abstract available. |
| 28567286 | Background | Abu Gazala M, Wexner SD. Re-appraisal and consideration of minimally invasive surgery in colorectal cancer. Gastroenterol Rep (Oxf). 2017 Feb;5(1):1-10. doi: 10.1093/gastro/gox001. Epub 2017 Feb 6. |
| 9079420 | Background | Bucholz RD. Introduction to Journal of Image Guided Surgery. J Image Guid Surg. 1995;1(1):1-3. doi: 10.1002/(SICI)1522-712X(1995)1:13.0.CO;2-E. No abstract available. |
| 26683419 | Background | Azagury DE, Dua MM, Barrese JC, Henderson JM, Buchs NC, Ris F, Cloyd JM, Martinie JB, Razzaque S, Nicolau S, Soler L, Marescaux J, Visser BC. Image-guided surgery. Curr Probl Surg. 2015 Dec;52(12):476-520. doi: 10.1067/j.cpsurg.2015.10.001. Epub 2015 Oct 22. No abstract available. |
| 23430289 | Background | Mezger U, Jendrewski C, Bartels M. Navigation in surgery. Langenbecks Arch Surg. 2013 Apr;398(4):501-14. doi: 10.1007/s00423-013-1059-4. Epub 2013 Feb 22. |
| 20822755 | Background | Pruliere-Escabasse V, Coste A. Image-guided sinus surgery. Eur Ann Otorhinolaryngol Head Neck Dis. 2010 Mar;127(1):33-9. doi: 10.1016/j.anorl.2010.02.009. Epub 2010 Mar 24. |
| 21435571 | Background | Risholm P, Golby AJ, Wells W 3rd. Multimodal image registration for preoperative planning and image-guided neurosurgical procedures. Neurosurg Clin N Am. 2011 Apr;22(2):197-206, viii. doi: 10.1016/j.nec.2010.12.001. |
| 20718266 | Background | Fitzpatrick JM. The role of registration in accurate surgical guidance. Proc Inst Mech Eng H. 2010;224(5):607-22. doi: 10.1243/09544119JEIM589. |
| 21803677 | Background | Wittmann W, Wenger T, Zaminer B, Lueth TC. Automatic correction of registration errors in surgical navigation systems. IEEE Trans Biomed Eng. 2011 Oct;58(10):2922-30. doi: 10.1109/TBME.2011.2163156. Epub 2011 Jul 29. |
| 28694888 | Background | Gundle KR, White JK, Conrad EU, Ching RP. Accuracy and Precision of a Surgical Navigation System: Effect of Camera and Patient Tracker Position and Number of Active Markers. Open Orthop J. 2017 May 31;11:493-501. doi: 10.2174/1874325001711010493. eCollection 2017. |
| 18366319 | Background | Baumhauer M, Feuerstein M, Meinzer HP, Rassweiler J. Navigation in endoscopic soft tissue surgery: perspectives and limitations. J Endourol. 2008 Apr;22(4):751-66. doi: 10.1089/end.2007.9827. |
| 29214516 | Background | Wijsmuller AR, Romagnolo LGC, Agnus V, Giraudeau C, Melani AGF, Dallemagne B, Marescaux J. Advances in stereotactic navigation for pelvic surgery. Surg Endosc. 2018 Jun;32(6):2713-2720. doi: 10.1007/s00464-017-5968-0. Epub 2017 Dec 6. |
| 24972925 | Background | Atallah S, Nassif G, Larach S. Stereotactic navigation for TAMIS-TME: opening the gateway to frameless, image-guided abdominal and pelvic surgery. Surg Endosc. 2015 Jan;29(1):207-11. doi: 10.1007/s00464-014-3655-y. Epub 2014 Jun 28. |
| 26153411 | Background | Atallah S, Martin-Perez B, Larach S. Image-guided real-time navigation for transanal total mesorectal excision: a pilot study. Tech Coloproctol. 2015 Nov;19(11):679-84. doi: 10.1007/s10151-015-1329-y. Epub 2015 Jul 9. |
| 27348417 | Background | Atallah S, Larach SW, Monson JR. Stereotactic navigation for TAMIS-TME. Minim Invasive Ther Allied Technol. 2016 Oct;25(5):271-7. doi: 10.1080/13645706.2016.1201119. Epub 2016 Jun 27. |
| 21963617 | Background | Bai M, Liu B, Mu H, Liu X, Jiang Y. The comparison of radiation dose between C-arm flat-detector CT (DynaCT) and multi-slice CT (MSCT): a phantom study. Eur J Radiol. 2012 Nov;81(11):3577-80. doi: 10.1016/j.ejrad.2011.09.006. Epub 2011 Oct 2. |
| 25830037 | Background | Raman SP, Chen Y, Fishman EK. Evolution of imaging in rectal cancer: multimodality imaging with MDCT, MRI, and PET. J Gastrointest Oncol. 2015 Apr;6(2):172-84. doi: 10.3978/j.issn.2078-6891.2014.108. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |