Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer

NCT03806244 | Terminated

• 1 other identifier: 18-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the feasibility and precision of stereotaxic navigation in laparoscopic surgery for colorectal cancer.

Conditions

Colorectal Cancer

Keywords

stereotactic navigation; colorectal cancer; laparoscopy; transanal surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Comparison, in millimeters, of the surgical navigation "accuracy" (as defined in the primary outcome) with or without intraoperative images acquisition

  up to 7 days post procedure

• 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

  up to 7 days post procedure

• Measurement of the overall operating time (in minutes) with and without intraoperative images acquisition

  up to 30 days post procedure

• Measurement of the level of radiation exposure to ionizing factors with and without intraoperative images acquisition

  up to 30 days post procedure

• Number of intra and/or postoperative complication

  up to 30 days post procedure

Study Arms (2)

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.

Other: Intraoperative acquisition (robotic c-Arm) of images

Interventions

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.

PEROP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is over 18 years old
• Patient presents with cancer
• Patient has no contraindication to anesthesia and surgical resection
• Patient able to receive and understand information about the study and give written informed consent
• Patient (s) affiliated to the national social security system.

You may not qualify if:

• Patient operated on urgently.
• Pregnant or lactating patient
• Patient under the protection of justice.
• Patient under guardianship or curatorship.

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, 67 091, France

Location

Related Publications (22)

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  PMID: 27766137 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.

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  PMID: 23430289 BACKGROUND

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• 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.

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• Fitzpatrick JM. The role of registration in accurate surgical guidance. Proc Inst Mech Eng H. 2010;224(5):607-22. doi: 10.1243/09544119JEIM589.

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• 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.

  PMID: 21803677 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.

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• 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.

  PMID: 18366319 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.

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• 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.

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• 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.

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• 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.

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Related Links

• Image-guided navigation surgery for pelvic malignancies using electromagnetic tracking - Proceedings of the SPIE
• Surgical Navigation Systems: A Technological Overview - Conference Paper · June 2014

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Didier Mutter, MD, PhD

  Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: July 17, 2019
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)