Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
833 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-03-31
Study Completion Date
2025-02-05
Brief Summary
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The laparoscopic approach for total mesorectal excision (L-TME) results improved short-term outcomes. However this approach has technical limitations when the pelvis is narrow and deep. Indeed there is a limited mobility of straight laparoscopic instruments and associated loss of dexterity, unstable camera view and compromised ergonomics for the surgeon. Robotic technology was developed to reduce these limitations and offers the advantages of intuitive manipulation of laparoscopic instruments with wrist articulation, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement and an ergonomic operating environment. A major advantage of the robotic approach is the surgeon's simultaneous control of the camera and of the two or three additional instruments. This advantage facilitates traction and counter-traction. The technological advantages of robotic surgery should also allow a finer dissection in a narrow pelvic cavity.
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Detailed Description
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The laparoscopic approach for laparoscopic total mesorectal excision (L-TME) results improved short-term outcomes and provides a clearer intraoperative view compared with the open approach in a deep and narrow pelvis. Preliminary results from the COLOR II trial confirmed improved patient recovery and similar safety, same resection margins and completeness of resection using L-TME compared with the results achieved with open surgery.Results from the CLASICC trial supported the use of laparoscopic surgery for colorectal cancer and showed no difference between laparoscopically-assisted TME and conventional open resection at 10 years post-procedure in terms of overall survival, disease-free survival and local recurrence.
Despite these positive clinical outcomes for L-TME, laparoscopic resection of rectal cancer, especially in a deep and narrow pelvis, is technically demanding and demands a long learning curve. Technical limitations include limited mobility of straight laparoscopic instruments and associated loss of dexterity, unstable camera view and compromised ergonomics for the surgeon. These limitations could explain the conversion rate which remained at 17% in the last COLOR II trial.2 In order to avoid this drawback, we have described for patients with high-risk of conversion, the trans-anal endoscopic proctectomy (TAEP) approach performed with the Transanal Endoscopic Operation (TEO) device.This trans-anal procedure is also called trans anal minimally invasive surgery (TAMIS) if a laparoscopic port is used.
Robotic technology was developed to reduce these limitations and offers the advantages of intuitive manipulation of laparoscopic instruments with wrist articulation, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement and an ergonomic operating environment. A major advantage of the robotic approach is the surgeon's simultaneous control of the camera and of the two or three additional instruments. This advantage facilitates traction and counter-traction. The technological advantages of robotic surgery should also allow a finer dissection in a narrow pelvic cavity. However, total robotic surgery for rectal cancer is still technically challenging and involves two operative fields (splenic flexure and rectum), potential collision of the robotic arms and lack of tactile feedback.
Reports of robotic and laparoscopic rectal cancer surgery outcomes showed similar intraoperative results and morbidity, postoperative recovery and short-term oncologic outcomes.However, longer operation times have been described as a disadvantage of the robotic system, compared with conventional laparoscopy. On the other hand, all meta-analyses comparing robotic total mesorectal excision (R-TME) and L-TME concluded in reduction of the conversion rate.
Since 2007, the rectal surgery with robotic assistance is booming. To date, seven meta-analyzes have been published. All show that the robot exceeds laparoscopy to reduce the conversion rate. The last two meta-analyzes that had gathered more than 800 patients undergoing robotic surgery have again highlighted the contribution of the robot to secure the radial margin and decrease sexual sequelae. However, there is not so far from Phase 3 randomized trial dealing with the subject. The ROLARR protocol was completed in late 2014 (Ph III laparoscopy / Robot), the first results are published in late 2015.
The interest of a European multicenter ambispective (retrospective and prospective) database is fundamental because this early work suggests that the robot can make more for specific subgroups of patients, particularly in high surgical risk patients (Male, narrow pelvis, high BMI, mesorectal fat, large tumor of the anterior and middle third).
The largest series of R-TME stems from the US national cancer database (965 patients operated by R-TME) and confirms a 9.5% conversion rate compared to 16.4% with L-TME (p \< 0.001).
Despite these positive clinical outcomes for L-TME, laparoscopic resection of rectal cancer, especially in a deep and narrow pelvis, is technically demanding and demands a long learning curve. Technical limitations include limited mobility of straight laparoscopic instruments and associated loss of dexterity, unstable camera view and compromised ergonomics for the surgeon. These limitations could explain the conversion rate which remained at 17% in the last COLOR II trial.2 In order to avoid this drawback, we have described for patients with high-risk of conversion, the trans-anal endoscopic proctectomy (TAEP) approach performed with the Transanal Endoscopic Operation (TEO) device.This trans-anal procedure is also called trans anal minimally invasive surgery (TAMIS) if a laparoscopic port is used.
Robotic technology was developed to reduce these limitations and offers the advantages of intuitive manipulation of laparoscopic instruments with wrist articulation, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement and an ergonomic operating environment. A major advantage of the robotic approach is the surgeon's simultaneous control of the camera and of the two or three additional instruments. This advantage facilitates traction and counter-traction. The technological advantages of robotic surgery should also allow a finer dissection in a narrow pelvic cavity. However, total robotic surgery for rectal cancer is still technically challenging and involves two operative fields (splenic flexure and rectum), potential collision of the robotic arms and lack of tactile feedback.
Reports of robotic and laparoscopic rectal cancer surgery outcomes showed similar intraoperative results and morbidity, postoperative recovery and short-term oncologic outcomes.However, longer operation times have been described as a disadvantage of the robotic system, compared with conventional laparoscopy. On the other hand, all meta-analyses comparing robotic total mesorectal excision (R-TME) and L-TME concluded in reduction of the conversion rate.
Since 2007, the rectal surgery with robotic assistance is booming. To date, seven meta-analyzes have been published. All show that the robot exceeds laparoscopy to reduce the conversion rate. The last two meta-analyzes that had gathered more than 800 patients undergoing robotic surgery have again highlighted the contribution of the robot to secure the radial margin and decrease sexual sequelae. However, there is not so far from Phase 3 randomized trial dealing with the subject. The ROLARR protocol was completed in late 2014 (Ph III laparoscopy / Robot), the first results are published in late 2015.
The interest of a European multicenter ambispective (retrospective and prospective) database is fundamental because this early work suggests that the robot can make more for specific subgroups of patients, particularly in high surgical risk patients (Male, narrow pelvis, high BMI, mesorectal fat, large tumor of the anterior and middle third).
The largest series of R-TME stems from the US national cancer database (965 patients operated by R-TME) and confirms a 9.5% conversion rate compared to 16.4% with L-TME (p \< 0.001).
Conditions
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Rectum Cancer
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Clinical database
Group Type
OTHER
Clinical database
Intervention Type
OTHER
Creation of an ambispective (retrospective and prospective), multicentric and European clinical database for surgery with robotic assistance in rectal cancers with implementation in France and then in Europe
Interventions
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Clinical database
Creation of an ambispective (retrospective and prospective), multicentric and European clinical database for surgery with robotic assistance in rectal cancers with implementation in France and then in Europe
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
1. Men or women ≥ 18 years
2. Introducing rectal cancer, colorectal junction eligible to robotic surgery support from June 2015
3. Treatment Naive for this cancer
4. Enjoying a social protection scheme (For France only)
5. Patient followed in the participant center
2. Introducing rectal cancer, colorectal junction eligible to robotic surgery support from June 2015
3. Treatment Naive for this cancer
4. Enjoying a social protection scheme (For France only)
5. Patient followed in the participant center
Exclusion Criteria
1. Male or female age (s) under 18 years
2. Private person of liberty or under supervision (including guardianship)
3. People who do not speak French (For France only)
4. Major Nobody unable to consent
5. Patient GROG-R01 already included in the base
6. Patient Refusal
2. Private person of liberty or under supervision (including guardianship)
3. People who do not speak French (For France only)
4. Major Nobody unable to consent
5. Patient GROG-R01 already included in the base
6. Patient Refusal
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Philippe Rouanet, MD
Role: STUDY_CHAIR
Institut régional du cancer de Montpellier
Locations
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UCL
Brussels, , Belgium
Site Status
Hôpital Européen
Marseille, Bouches Du Rhône, France
Site Status
Institut Paoli Calmettes
Marseille, Bouches Du Rhône, France
Site Status
Centre François Baclesse
Caen, Calvados, France
Site Status
Clinique Kennedy
Nîmes, Gard, France
Site Status
Clinique Saint Jean du Languedoc
Toulouse, Haute Garonne, France
Site Status
CHU Dupuytren
Limoges, Haute Vienne, France
Site Status
Hôpital privé d'Anthony
Antony, Hauts De Seine, France
Site Status
Institut régional du cancer de Montpellier
Montpellier, Hérault, France
Site Status
Hôpital Michalon
Grenoble, Isère, France
Site Status
CHU de Nantes
Nantes, Loire Atlantique, France
Site Status
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire Atlantique, France
Site Status
CHR Orléans
Orléans, Loiret, France
Site Status
CHU de Nancy
Vandœuvre-lès-Nancy, Lorraine, France
Site Status
Centre Oscart Lambret
Lille, Nord, France
Site Status
Institut Gustave Roussy
Villejuif, Val De Marne, France
Site Status
Hôpital Diaconesses
Paris, , France
Site Status
Hôpital européen Georges Pompidou
Paris, , France
Site Status
Centre Hospitalier-Princesse Grace
Monaco, , Monaco
Site Status
Countries
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Belgium
France
Monaco
References
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Green BL, Marshall HC, Collinson F, Quirke P, Guillou P, Jayne DG, Brown JM. Long-term follow-up of the Medical Research Council CLASICC trial of conventional versus laparoscopically assisted resection in colorectal cancer. Br J Surg. 2013 Jan;100(1):75-82. doi: 10.1002/bjs.8945. Epub 2012 Nov 6.
Reference Type
BACKGROUND
van der Pas MH, Haglind E, Cuesta MA, Furst A, Lacy AM, Hop WC, Bonjer HJ; COlorectal cancer Laparoscopic or Open Resection II (COLOR II) Study Group. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013 Mar;14(3):210-8. doi: 10.1016/S1470-2045(13)70016-0. Epub 2013 Feb 6.
Reference Type
BACKGROUND
Rouanet P, Mourregot A, Azar CC, Carrere S, Gutowski M, Quenet F, Saint-Aubert B, Colombo PE. Transanal endoscopic proctectomy: an innovative procedure for difficult resection of rectal tumors in men with narrow pelvis. Dis Colon Rectum. 2013 Apr;56(4):408-15. doi: 10.1097/DCR.0b013e3182756fa0.
Reference Type
BACKGROUND
Fernandez-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Diaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865.
Reference Type
BACKGROUND
Sylla P, Rattner DW, Delgado S, Lacy AM. NOTES transanal rectal cancer resection using transanal endoscopic microsurgery and laparoscopic assistance. Surg Endosc. 2010 May;24(5):1205-10. doi: 10.1007/s00464-010-0965-6. Epub 2010 Feb 26.
Reference Type
BACKGROUND
Atallah S, Martin-Perez B, Albert M, deBeche-Adams T, Nassif G, Hunter L, Larach S. Transanal minimally invasive surgery for total mesorectal excision (TAMIS-TME): results and experience with the first 20 patients undergoing curative-intent rectal cancer surgery at a single institution. Tech Coloproctol. 2014 May;18(5):473-80. doi: 10.1007/s10151-013-1095-7. Epub 2013 Nov 23.
Reference Type
BACKGROUND
D'Annibale A, Pernazza G, Monsellato I, Pende V, Lucandri G, Mazzocchi P, Alfano G. Total mesorectal excision: a comparison of oncological and functional outcomes between robotic and laparoscopic surgery for rectal cancer. Surg Endosc. 2013 Jun;27(6):1887-95. doi: 10.1007/s00464-012-2731-4. Epub 2013 Jan 5.
Reference Type
BACKGROUND
Kwak JM, Kim SH, Kim J, Son DN, Baek SJ, Cho JS. Robotic vs laparoscopic resection of rectal cancer: short-term outcomes of a case-control study. Dis Colon Rectum. 2011 Feb;54(2):151-6. doi: 10.1007/DCR.0b013e3181fec4fd.
Reference Type
BACKGROUND
Park JS, Choi GS, Lim KH, Jang YS, Jun SH. Robotic-assisted versus laparoscopic surgery for low rectal cancer: case-matched analysis of short-term outcomes. Ann Surg Oncol. 2010 Dec;17(12):3195-202. doi: 10.1245/s10434-010-1162-5. Epub 2010 Jun 30.
Reference Type
BACKGROUND
Patel CB, Ragupathi M, Ramos-Valadez DI, Haas EM. A three-arm (laparoscopic, hand-assisted, and robotic) matched-case analysis of intraoperative and postoperative outcomes in minimally invasive colorectal surgery. Dis Colon Rectum. 2011 Feb;54(2):144-50. doi: 10.1007/DCR.0b013e3181fec377.
Reference Type
BACKGROUND
Bianchi PP, Ceriani C, Locatelli A, Spinoglio G, Zampino MG, Sonzogni A, Crosta C, Andreoni B. Robotic versus laparoscopic total mesorectal excision for rectal cancer: a comparative analysis of oncological safety and short-term outcomes. Surg Endosc. 2010 Nov;24(11):2888-94. doi: 10.1007/s00464-010-1134-7. Epub 2010 Jun 5.
Reference Type
BACKGROUND
Popescu I, Vasilescu C, Tomulescu V, Vasile S, Sgarbura O. The minimally invasive approach, laparoscopic and robotic, in rectal resection for cancer. A single center experience. Acta Chir Iugosl. 2010;57(3):29-35. doi: 10.2298/aci1003029p.
Reference Type
BACKGROUND
Lin S, Jiang HG, Chen ZH, Zhou SY, Liu XS, Yu JR. Meta-analysis of robotic and laparoscopic surgery for treatment of rectal cancer. World J Gastroenterol. 2011 Dec 21;17(47):5214-20. doi: 10.3748/wjg.v17.i47.5214.
Reference Type
BACKGROUND
Trastulli S, Farinella E, Cirocchi R, Cavaliere D, Avenia N, Sciannameo F, Gulla N, Noya G, Boselli C. Robotic resection compared with laparoscopic rectal resection for cancer: systematic review and meta-analysis of short-term outcome. Colorectal Dis. 2012 Apr;14(4):e134-56. doi: 10.1111/j.1463-1318.2011.02907.x.
Reference Type
BACKGROUND
Memon S, Heriot AG, Murphy DG, Bressel M, Lynch AC. Robotic versus laparoscopic proctectomy for rectal cancer: a meta-analysis. Ann Surg Oncol. 2012 Jul;19(7):2095-101. doi: 10.1245/s10434-012-2270-1. Epub 2012 Feb 16.
Reference Type
BACKGROUND
Yang Y, Wang F, Zhang P, Shi C, Zou Y, Qin H, Ma Y. Robot-assisted versus conventional laparoscopic surgery for colorectal disease, focusing on rectal cancer: a meta-analysis. Ann Surg Oncol. 2012 Nov;19(12):3727-36. doi: 10.1245/s10434-012-2429-9. Epub 2012 Jul 3.
Reference Type
BACKGROUND
Gonzalez Fernandez AM, Mascarenas Gonzalez JF. [Total laparoscopic mesorectal excision versus robot-assisted in the treatment of rectal cancer: a meta-analysis]. Cir Esp. 2012 Jun-Jul;90(6):348-54. doi: 10.1016/j.ciresp.2012.03.004. Epub 2012 Apr 24. Spanish.
Reference Type
BACKGROUND
Ortiz-Oshiro E, Sanchez-Egido I, Moreno-Sierra J, Perez CF, Diaz JS, Fernandez-Represa JA. Robotic assistance may reduce conversion to open in rectal carcinoma laparoscopic surgery: systematic review and meta-analysis. Int J Med Robot. 2012 Sep;8(3):360-70. doi: 10.1002/rcs.1426. Epub 2012 Mar 22.
Reference Type
BACKGROUND
Xiong B, Ma L, Zhang C, Cheng Y. Robotic versus laparoscopic total mesorectal excision for rectal cancer: a meta-analysis. J Surg Res. 2014 May 15;188(2):404-14. doi: 10.1016/j.jss.2014.01.027. Epub 2014 Jan 22.
Reference Type
BACKGROUND
Son GM, Kim JG, Lee JC, Suh YJ, Cho HM, Lee YS, Lee IK, Chun CS. Multidimensional analysis of the learning curve for laparoscopic rectal cancer surgery. J Laparoendosc Adv Surg Tech A. 2010 Sep;20(7):609-17. doi: 10.1089/lap.2010.0007.
Reference Type
BACKGROUND
Kim HJ, Choi GS, Park JS, Park SY. Multidimensional analysis of the learning curve for robotic total mesorectal excision for rectal cancer: lessons from a single surgeon's experience. Dis Colon Rectum. 2014 Sep;57(9):1066-74. doi: 10.1097/DCR.0000000000000174.
Reference Type
BACKGROUND
Jimenez-Rodriguez RM, Diaz-Pavon JM, de la Portilla de Juan F, Prendes-Sillero E, Dussort HC, Padillo J. Learning curve for robotic-assisted laparoscopic rectal cancer surgery. Int J Colorectal Dis. 2013 Jun;28(6):815-21. doi: 10.1007/s00384-012-1620-6. Epub 2012 Dec 15.
Reference Type
BACKGROUND
Kuo LJ, Lin YK, Chang CC, Tai CJ, Chiou JF, Chang YJ. Clinical outcomes of robot-assisted intersphincteric resection for low rectal cancer: comparison with conventional laparoscopy and multifactorial analysis of the learning curve for robotic surgery. Int J Colorectal Dis. 2014 May;29(5):555-62. doi: 10.1007/s00384-014-1841-y. Epub 2014 Feb 23.
Reference Type
BACKGROUND
Baek JH, Pastor C, Pigazzi A. Robotic and laparoscopic total mesorectal excision for rectal cancer: a case-matched study. Surg Endosc. 2011 Feb;25(2):521-5. doi: 10.1007/s00464-010-1204-x. Epub 2010 Jul 7.
Reference Type
BACKGROUND
Park YA, Kim JM, Kim SA, Min BS, Kim NK, Sohn SK, Lee KY. Totally robotic surgery for rectal cancer: from splenic flexure to pelvic floor in one setup. Surg Endosc. 2010 Mar;24(3):715-20. doi: 10.1007/s00464-009-0656-3. Epub 2009 Aug 18.
Reference Type
BACKGROUND
Speicher PJ, Englum BR, Ganapathi AM, Nussbaum DP, Mantyh CR, Migaly J. Robotic Low Anterior Resection for Rectal Cancer: A National Perspective on Short-term Oncologic Outcomes. Ann Surg. 2015 Dec;262(6):1040-5. doi: 10.1097/SLA.0000000000001017.
Reference Type
BACKGROUND
Tuech JJ, Karoui M, Lelong B, De Chaisemartin C, Bridoux V, Manceau G, Delpero JR, Hanoun L, Michot F. A step toward NOTES total mesorectal excision for rectal cancer: endoscopic transanal proctectomy. Ann Surg. 2015 Feb;261(2):228-33. doi: 10.1097/SLA.0000000000000994.
Reference Type
BACKGROUND
Wolthuis AM, de Buck van Overstraeten A, D'Hoore A. Dynamic article: transanal rectal excision: a pilot study. Dis Colon Rectum. 2014 Jan;57(1):105-9. doi: 10.1097/DCR.0000000000000008.
Reference Type
BACKGROUND
Dumont F, Goere D, Honore C, Elias D. Transanal endoscopic total mesorectal excision combined with single-port laparoscopy. Dis Colon Rectum. 2012 Sep;55(9):996-1001. doi: 10.1097/DCR.0b013e318260d3a0.
Reference Type
BACKGROUND
Zorron R, Phillips HN, Coelho D, Flach L, Lemos FB, Vassallo RC. Perirectal NOTES access: "down-to-up" total mesorectal excision for rectal cancer. Surg Innov. 2012 Mar;19(1):11-9. doi: 10.1177/1553350611409956. Epub 2011 Jul 7.
Reference Type
BACKGROUND
Other Identifiers
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ICM-BDD 2015/05
Identifier Type: -
Identifier Source: org_study_id
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