Clinical Database of Colorectal Robotic Surgery

Ulcerative Colitis Clinical Trial

— ROBOT CR  

Official title:

French Prospective Clinical Database of Colorectal Robotic Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04013152
• Other study ID #: PROICM 2017-05 ROB
• Status: Active, not recruiting
• Start date: June 13, 2018
• Est. completion date: June 9, 2027

Study information

• Verified date: January 2024
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1800
• Est. completion date: June 9, 2027
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Colorectal Tumor
• Colitis
• Colorectal Neoplasms
• Colorectal Tumor
• Crohn Disease
• Diverticulitis
• Polyposis
• Prolapse
• Rectal Prolapse
• Ulcerative Colitis

Intervention

Other:
• Clinical database
Constitution of a prospective, multicenter clinical database of surgery with robotic assistance in colorectal pathologies

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux	Gironde
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Puy De Dôme
France	CHU de Lyon	Lyon	Rhône
France	Institut régional du cancer de Montpellier	Montpellier	Hérault

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (11)

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. — View Citation

Bertrand MM, Colombo PE, Mourregot A, Traore D, Carrere S, Quenet 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. — View Citation

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. — View Citation

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. doi: 10.1093/intqhc/12.5.433. — View Citation

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. — View Citation

Colombo PE, Bertrand MM, Alline M, Boulay E, Mourregot A, Carrere S, Quenet 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. — View Citation

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. — View Citation

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. doi: 10.1200/JCO.2002.07.010. — View Citation

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. — View Citation

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. doi: 10.1136/bmj.316.7146.1697. Erratum In: BMJ 1998 Jun 27;316(7149):1947. — View Citation

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. doi: 10.1007/s00464-016-4892-z. Epub 2016 Jul 11. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of clinical data following surgery with robotic assistance in colorectal pathologies		3 years
Secondary	Time of learning for each surgical technique by determining a learning curve for each of them		3 years
Secondary	The conversion rate of surgical technique		3 years
Secondary	Operating time		3 years
Secondary	Intraoperative complications rate		3 years
Secondary	Duration of hospital stay		1 month
Secondary	local relapse-free survival		8 years
Secondary	overall survival		8 years
Secondary	Digestive functionality assessment by using the Low Anterior Resection Syndrome score (LARS)	This questionnaire assessed the bowel function of patient. The range is from 8 (low function) to 35 (high function)	3 years
Secondary	The Erectile Function of patient by using the II-EF-5 score (The International Index of Erectile Function)	The range is from 1 (low erectile function) to 27 (high erectile function)	3 years
Secondary	The dysfunction of female Sexual Function by using the Index FSFI (The Female Sexual Function Index) score	The range is from 3 (low sexual function) to 55 (high sexual function).	3 years
Secondary	Urinary functionality by using the questionnaire of urinary function	The range is from 0 (low urinary function) to 40 (high urinary function).	3 years
Secondary	Objective surgeon performance metrics using a novel recorder (dVLogger) to directly capture surgeon manipulations on the da Vinci Surgical System		3 years
Secondary	Number of lymph node resected		3 years
Secondary	Quality of the mesorectum by using Quirke classification	The quality of the mesorectum resection is determined by the pathologist according to the aspect of mesorectum, the circumferential resection margin, cone effect .	3 years