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出境医 / 临床实验 / Clinical Database of Colorectal Robotic Surgery (ROBOT CR)

Clinical Database of Colorectal Robotic Surgery (ROBOT CR)

Study Description
Brief Summary:
Evaluation of robot Da Vinci Xi by determining its learning curve.The operating time will be defined by patient then the operating average will be calculated.

Condition or disease Intervention/treatment Phase
Crohn Disease Polyposis Ulcerative Colitis Diverticulitis Colorectal Tumor Rectal Prolapse Benign Colorectal Tumor Other: Clinical database Not Applicable

Detailed Description:

Since the emergence of minimally invasive technology twenty years ago, as a surgical concept and surgical technique for colorectal cancer surgery, its obvious advantages have been recognized.

Laparoscopic technology, as one of the most important technology platform, has got a lot of evidence-based support for the oncological safety and effectiveness in colorectal cancer surgery Laparoscopic technique has advantages in terms of identification of anatomic plane and autonomic nerve, protection of pelvic structure, and fine dissection of vessels.

But because of the limitation of laparoscopic technology there are still some deficiencies and shortcomings, including lack of touch and lack of stereo vision problems, in addition to the low rectal cancer, especially male, obese, narrow pelvis, larger tumors, it is difficult to get better view and manipulating triangle in laparoscopy. However, the emergence of a series of new minimally invasive technology platform is to make up for the defects and deficiencies. The robotic surgical system possesses advantages, such as stereo vision, higher magnification, manipulator wrist with high freedom degree, filtering of tremor and higher stability, but still has disadvantages, such as lack of haptic feedback, longer operation time, high operation cost and expensive price.

3D system of laparoscopic surgery has similar visual experience and feelings as robotic surgery in the 3D view, the same operating skills as 2D laparoscopy and a short learning curve. Transanal total mesorectal excision (taTME) by changing the traditional laparoscopic pelvic surgery approach, may have certain advantages for male cases with narrow pelvic and patients with large tumor.

No prospective study has compared these four surgical techniques. Furthermore, the learning curve still remains a crucial problem in term of data interpretation.

We will collect synchronized videos and data on surgeon performance during colorectal surgeries using the Vinci Logger (dVLogger, Intuitive Surgical, Inc.), it is a personalized recording tool that captures synchronized video in the form of endoscope view at 30 frames per second. Kinematic data included characteristics of movement such as instrument travel time, path length and velocity. Events included frequency of master controller clutch use, camera movements, third arm swap and energy use.

We will explore and validate objective surgeon performance metrics using novel recorder ("dVLogger") to directly capture surgeon manipulations on the daVinci Surgical System.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: French Prospective Clinical Database of Colorectal Robotic Surgery
Actual Study Start Date : June 13, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2026
Arms and Interventions
Arm Intervention/treatment
Experimental: clinical database Other: Clinical database
Constitution of a prospective, multicenter clinical database of surgery with robotic assistance in colorectal pathologies
Outcome Measures
Primary Outcome Measures :
  1. Collection of clinical data following surgery with robotic assistance in colorectal pathologies [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Time of learning for each surgical technique by determining a learning curve for each of them [ Time Frame: 3 years ]
  2. The conversion rate of surgical technique [ Time Frame: 3 years ]
  3. Operating time [ Time Frame: 3 years ]
  4. Intraoperative complications rate [ Time Frame: 3 years ]
  5. Duration of hospital stay [ Time Frame: 1 month ]
  6. local relapse-free survival [ Time Frame: 8 years ]
  7. overall survival [ Time Frame: 8 years ]
  8. Digestive functionality assessment by using the Low Anterior Resection Syndrome score (LARS) [ Time Frame: 3 years ]
    This questionnaire assessed the bowel function of patient. The range is from 8 (low function) to 35 (high function)

  9. The Erectile Function of patient by using the II-EF-5 score (The International Index of Erectile Function) [ Time Frame: 3 years ]
    The range is from 1 (low erectile function) to 27 (high erectile function)

  10. The dysfunction of female Sexual Function by using the Index FSFI (The Female Sexual Function Index) score [ Time Frame: 3 years ]
    The range is from 3 (low sexual function) to 55 (high sexual function).

  11. Urinary functionality by using the questionnaire of urinary function [ Time Frame: 3 years ]
    The range is from 0 (low urinary function) to 40 (high urinary function).

  12. Objective surgeon performance metrics using a novel recorder (dVLogger) to directly capture surgeon manipulations on the da Vinci Surgical System [ Time Frame: 3 years ]
  13. Number of lymph node resected [ Time Frame: 3 years ]
  14. Quality of the mesorectum by using Quirke classification [ Time Frame: 3 years ]
    The quality of the mesorectum resection is determined by the pathologist according to the aspect of mesorectum, the circumferential resection margin, cone effect .


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥ 18 years
  2. Colorectal pathologies (Crohn's disease, Polyposis, Ulcerative colitis, Diverticulitis, Colorectal tumor, Rectal prolapse, Benign and colorectal tumor) eligible for robotic surgery.
  3. Major techniques: right and left colectomy, rectal excision (low anterior resection, intersphincteric resection, abdominoperineal resection), Hartman reversal
  4. Or, Minor techniques: rectopexy, shaving for rectal endometriosis,
  5. Or, Complex techniques: extended rectal excision for T4 cancer, pelvectomy, redo surgery.
  6. Patient affiliated to a social security regimen
  7. Patient information for study

Exclusion Criteria:

  1. Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study
  2. Patient under tutelage, curatorship or safeguard of justice
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jean-Pïerre Bleuse, MD 4 67 61 31 02 ext +33 jean-pierre.bleuse@icm.unicancer.fr

Locations
Layout table for location information
France
CHU de Bordeaux Recruiting
Bordeaux, Gironde, France, 33600
Contact: Eric Rullier, MD         
Institut régional du cancer de Montpellier Recruiting
Montpellier, Hérault, France, 34298
Contact: Philippe Rouanet, MD    4 67 61 45 86 ext +33    philippe.rouanet@icm.unicancer.fr   
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, Puy De Dôme, France, 63103
Contact: Anne Dubois, MD    4 73 75 04 94 ext +33    a_dubois@chu-clermontferrand.fr   
CHU de Lyon Recruiting
Lyon, Rhône, France, 69310
Contact: Eddy Cotte, MD    6 07 67 86 09 ext +33    eddy.cotte@chu-lyon.fr   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Layout table for investigator information
Study Chair: Philippe Rouanet, MD Institut régional du cancer de Montpellier
Tracking Information
First Submitted Date  ICMJE July 4, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date August 4, 2020
Actual Study Start Date  ICMJE June 13, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2019) 		Collection of clinical data following surgery with robotic assistance in colorectal pathologies [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • Time of learning for each surgical technique by determining a learning curve for each of them [ Time Frame: 3 years ]
  • The conversion rate of surgical technique [ Time Frame: 3 years ]
  • Operating time [ Time Frame: 3 years ]
  • Intraoperative complications rate [ Time Frame: 3 years ]
  • Duration of hospital stay [ Time Frame: 1 month ]
  • local relapse-free survival [ Time Frame: 8 years ]
  • overall survival [ Time Frame: 8 years ]
  • Digestive functionality assessment by using the Low Anterior Resection Syndrome score (LARS) [ Time Frame: 3 years ]
    This questionnaire assessed the bowel function of patient. The range is from 8 (low function) to 35 (high function)
  • The Erectile Function of patient by using the II-EF-5 score (The International Index of Erectile Function) [ Time Frame: 3 years ]
    The range is from 1 (low erectile function) to 27 (high erectile function)
  • The dysfunction of female Sexual Function by using the Index FSFI (The Female Sexual Function Index) score [ Time Frame: 3 years ]
    The range is from 3 (low sexual function) to 55 (high sexual function).
  • Urinary functionality by using the questionnaire of urinary function [ Time Frame: 3 years ]
    The range is from 0 (low urinary function) to 40 (high urinary function).
  • Objective surgeon performance metrics using a novel recorder (dVLogger) to directly capture surgeon manipulations on the da Vinci Surgical System [ Time Frame: 3 years ]
  • Number of lymph node resected [ Time Frame: 3 years ]
  • Quality of the mesorectum by using Quirke classification [ Time Frame: 3 years ]
    The quality of the mesorectum resection is determined by the pathologist according to the aspect of mesorectum, the circumferential resection margin, cone effect .
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Database of Colorectal Robotic Surgery
Official Title  ICMJE French Prospective Clinical Database of Colorectal Robotic Surgery
Brief Summary Evaluation of robot Da Vinci Xi by determining its learning curve.The operating time will be defined by patient then the operating average will be calculated.
Detailed Description

Since the emergence of minimally invasive technology twenty years ago, as a surgical concept and surgical technique for colorectal cancer surgery, its obvious advantages have been recognized.

Laparoscopic technology, as one of the most important technology platform, has got a lot of evidence-based support for the oncological safety and effectiveness in colorectal cancer surgery Laparoscopic technique has advantages in terms of identification of anatomic plane and autonomic nerve, protection of pelvic structure, and fine dissection of vessels.

But because of the limitation of laparoscopic technology there are still some deficiencies and shortcomings, including lack of touch and lack of stereo vision problems, in addition to the low rectal cancer, especially male, obese, narrow pelvis, larger tumors, it is difficult to get better view and manipulating triangle in laparoscopy. However, the emergence of a series of new minimally invasive technology platform is to make up for the defects and deficiencies. The robotic surgical system possesses advantages, such as stereo vision, higher magnification, manipulator wrist with high freedom degree, filtering of tremor and higher stability, but still has disadvantages, such as lack of haptic feedback, longer operation time, high operation cost and expensive price.

3D system of laparoscopic surgery has similar visual experience and feelings as robotic surgery in the 3D view, the same operating skills as 2D laparoscopy and a short learning curve. Transanal total mesorectal excision (taTME) by changing the traditional laparoscopic pelvic surgery approach, may have certain advantages for male cases with narrow pelvic and patients with large tumor.

No prospective study has compared these four surgical techniques. Furthermore, the learning curve still remains a crucial problem in term of data interpretation.

We will collect synchronized videos and data on surgeon performance during colorectal surgeries using the Vinci Logger (dVLogger, Intuitive Surgical, Inc.), it is a personalized recording tool that captures synchronized video in the form of endoscope view at 30 frames per second. Kinematic data included characteristics of movement such as instrument travel time, path length and velocity. Events included frequency of master controller clutch use, camera movements, third arm swap and energy use.

We will explore and validate objective surgeon performance metrics using novel recorder ("dVLogger") to directly capture surgeon manipulations on the daVinci Surgical System.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Crohn Disease
  • Polyposis
  • Ulcerative Colitis
  • Diverticulitis
  • Colorectal Tumor
  • Rectal Prolapse
  • Benign Colorectal Tumor
Intervention  ICMJE Other: Clinical database
Constitution of a prospective, multicenter clinical database of surgery with robotic assistance in colorectal pathologies
Study Arms  ICMJE Experimental: clinical database
Intervention: Other: Clinical database
Publications *
  • Colombo PE, Bertrand MM, Alline M, Boulay E, Mourregot A, Carrère S, Quénet F, Jarlier M, Rouanet P. Robotic Versus Laparoscopic Total Mesorectal Excision (TME) for Sphincter-Saving Surgery: Is There Any Difference in the Transanal TME Rectal Approach? : A Single-Center Series of 120 Consecutive Patients. Ann Surg Oncol. 2016 May;23(5):1594-600. doi: 10.1245/s10434-015-5048-4. Epub 2015 Dec 29.
  • Bertrand MM, Colombo PE, Mourregot A, Traore D, Carrère S, Quénet F, Rouanet P. Standardized single docking, four arms and fully robotic proctectomy for rectal cancer: the key points are the ports and arms placement. J Robot Surg. 2016 Jun;10(2):171-4. doi: 10.1007/s11701-015-0551-y. Epub 2015 Dec 8.
  • Nagtegaal ID, van de Velde CJ, van der Worp E, Kapiteijn E, Quirke P, van Krieken JH; Cooperative Clinical Investigators of the Dutch Colorectal Cancer Group. Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control. J Clin Oncol. 2002 Apr 1;20(7):1729-34.
  • Chen SL, Steele SR, Eberhardt J, Zhu K, Bilchik A, Stojadinovic A. Lymph node ratio as a quality and prognostic indicator in stage III colon cancer. Ann Surg. 2011 Jan;253(1):82-7. doi: 10.1097/SLA.0b013e3181ffa780.
  • Zhang X, Wei Z, Bie M, Peng X, Chen C. Robot-assisted versus laparoscopic-assisted surgery for colorectal cancer: a meta-analysis. Surg Endosc. 2016 Dec;30(12):5601-5614. Epub 2016 Jul 11. Review.
  • Parc Y, Reboul-Marty J, Lefevre JH, Shields C, Chafai N, Tiret E. Factors influencing mortality and morbidity following colorectal resection in France. Analysis of a national database (2009-2011). Colorectal Dis. 2016 Feb;18(2):205-13. doi: 10.1111/codi.13099.
  • Bege T, Lelong B, Esterni B, Turrini O, Guiramand J, Francon D, Mokart D, Houvenaeghel G, Giovannini M, Delpero JR. The learning curve for the laparoscopic approach to conservative mesorectal excision for rectal cancer: lessons drawn from a single institution's experience. Ann Surg. 2010 Feb;251(2):249-53. doi: 10.1097/SLA.0b013e3181b7fdb0.
  • Poloniecki J, Valencia O, Littlejohns P. Cumulative risk adjusted mortality chart for detecting changes in death rate: observational study of heart surgery. BMJ. 1998 Jun 6;316(7146):1697-700. Erratum in: BMJ 1998 Jun 27;316(7149):1947.
  • Guend H, Widmar M, Patel S, Nash GM, Paty PB, Guillem JG, Temple LK, Garcia-Aguilar J, Weiser MR. Developing a robotic colorectal cancer surgery program: understanding institutional and individual learning curves. Surg Endosc. 2017 Jul;31(7):2820-2828. doi: 10.1007/s00464-016-5292-0. Epub 2016 Nov 4.
  • Bokhari MB, Patel CB, Ramos-Valadez DI, Ragupathi M, Haas EM. Learning curve for robotic-assisted laparoscopic colorectal surgery. Surg Endosc. 2011 Mar;25(3):855-60. doi: 10.1007/s00464-010-1281-x. Epub 2010 Aug 24.
  • Bolsin S, Colson M. The use of the Cusum technique in the assessment of trainee competence in new procedures. Int J Qual Health Care. 2000 Oct;12(5):433-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2019) 		1800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2026
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female ≥ 18 years
  2. Colorectal pathologies (Crohn's disease, Polyposis, Ulcerative colitis, Diverticulitis, Colorectal tumor, Rectal prolapse, Benign and colorectal tumor) eligible for robotic surgery.
  3. Major techniques: right and left colectomy, rectal excision (low anterior resection, intersphincteric resection, abdominoperineal resection), Hartman reversal
  4. Or, Minor techniques: rectopexy, shaving for rectal endometriosis,
  5. Or, Complex techniques: extended rectal excision for T4 cancer, pelvectomy, redo surgery.
  6. Patient affiliated to a social security regimen
  7. Patient information for study

Exclusion Criteria:

  1. Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study
  2. Patient under tutelage, curatorship or safeguard of justice
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jean-Pïerre Bleuse, MD 4 67 61 31 02 ext +33 jean-pierre.bleuse@icm.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013152
Other Study ID Numbers  ICMJE PROICM 2017-05 ROB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Philippe Rouanet, MD Institut régional du cancer de Montpellier
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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