Robotic Low Rectum Anterior Resection

NCT04015804 | Completed

• 1 other identifier: ICM-BDD 2015/05
• Study Type: interventional
• Target: 833
• Locations: 3 countries
• Sites: 19

Brief Summary

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.

Conditions

Rectum Cancer

Keywords

cancer; rectum; robot

Outcome Measures

Primary Outcomes (1)

• Conversion rate for robotic surgery

  5 years

Secondary Outcomes (5)

• Anatomo-pathological curability criteria

  5 years

• Median of hospitalization time

  5 years

• Post-operative morbidity

  5 years

• Number of robot docking

  5 years

• Operating time

  5 years

Study Arms (1)

Clinical database

OTHER

Other: Clinical database

Interventions

Clinical database 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

Clinical database

Eligibility Criteria

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

You may qualify if:

• Men or women ≥ 18 years
• Introducing rectal cancer, colorectal junction eligible to robotic surgery support from June 2015
• Treatment Naive for this cancer
• Enjoying a social protection scheme (For France only)
• Patient followed in the participant center

You may not qualify if:

• Male or female age (s) under 18 years
• Private person of liberty or under supervision (including guardianship)
• People who do not speak French (For France only)
• Major Nobody unable to consent
• Patient GROG-R01 already included in the base
• Patient Refusal

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (19)

UCL

Brussels, Belgium

Location

Hôpital Européen

Marseille, Bouches Du Rhône, 13003, France

Location

Institut Paoli Calmettes

Marseille, Bouches Du Rhône, 13273, France

Location

Centre François Baclesse

Caen, Calvados, 14000, France

Location

Clinique Kennedy

Nîmes, Gard, 30900, France

Location

Clinique Saint Jean du Languedoc

Toulouse, Haute Garonne, 31000, France

Location

CHU Dupuytren

Limoges, Haute Vienne, 87042, France

Location

Hôpital privé d'Anthony

Antony, Hauts De Seine, 92160, France

Location

Institut régional du cancer de Montpellier

Montpellier, Hérault, 34298, France

Location

Hôpital Michalon

Grenoble, Isère, 38043, France

Location

CHU de Nantes

Nantes, Loire Atlantique, 44093, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire Atlantique, 44805, France

Location

CHR Orléans

Orléans, Loiret, 45100, France

Location

CHU de Nancy

Vandœuvre-lès-Nancy, Lorraine, 54511, France

Location

Centre Oscart Lambret

Lille, Nord, 59000, France

Location

Institut Gustave Roussy

Villejuif, Val De Marne, 94800, France

Location

Hôpital Diaconesses

Paris, 75020, France

Location

Hôpital européen Georges Pompidou

Paris, 75908, France

Location

Centre Hospitalier-Princesse Grace

Monaco, 98012, Monaco

Location

Related Publications (30)

• 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.

  PMID: 23132548 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.

  PMID: 23395398 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.

  PMID: 23478607 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.

  PMID: 25185463 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.

  PMID: 20186432 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.

  PMID: 24272607 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.

  PMID: 23292566 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.

  PMID: 21228661 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.

  PMID: 20589436 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.

  PMID: 21228660 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.

  PMID: 20526623 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.

  PMID: 21066980 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.

  PMID: 22215947 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.

  PMID: 22151033 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.

  PMID: 22350601 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.

  PMID: 22752371 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.

  PMID: 22537895 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.

  PMID: 22438060 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.

  PMID: 24565506 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.

  PMID: 20701545 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.

  PMID: 25101602 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.

  PMID: 23242270 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.

  PMID: 24562546 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.

  PMID: 20607559 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.

  PMID: 19688388 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.

  PMID: 25405559 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.

  PMID: 25361216 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.

  PMID: 24316953 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.

  PMID: 22874608 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.

  PMID: 21742663 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Philippe Rouanet, MD

  Institut régional du cancer de Montpellier

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 11, 2019
• Study Start: March 1, 2015
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (17); MO (1); BE (1)