Top

International Journal of Colorectal Disease

Published in:

01-02-2012 | Original Article

An international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer

Authors: Fiona J. Collinson, David G. Jayne, Alessio Pigazzi, Charles Tsang, Jennifer M. Barrie, Richard Edlin, Christopher Garbett, Pierre Guillou, Ivana Holloway, Helen Howard, Helen Marshall, Christopher McCabe, Sue Pavitt, Phil Quirke, Carly S. Rivers, Julia M. B. Brown

Published in: International Journal of Colorectal Disease | Issue 2/2012

Abstract

Purpose

There is growing enthusiasm for robotic-assisted laparoscopic operations across many surgical specialities, including colorectal surgery, often not supported by robust clinical or cost-effectiveness data. A proper assessment of this new technology is required, prior to widespread recommendation or implementation.

Methods/design

The ROLARR trial is a pan-world, prospective, randomised, controlled, unblinded, superiority trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer. It will investigate differences in terms of the rate of conversion to open operation, rate of pathological involvement of circumferential resection margin, 3-year local recurrence, disease-free and overall survival rates and also operative morbidity and mortality, quality of life and cost-effectiveness. The primary outcome measure is the rate of conversion to open operation. For 80% power at the 5% (two-sided) significance level, to identify a relative 50% reduction in open conversion rate (25% to 12.5%), 336 patients will be required. The target recruitment is 400 patients overall to allow loss to follow-up. Patients will be followed up at 30 days and 6 months post-operatively and then annually until 3 years after the last patient has been randomised.

Discussion

In many centres, robotic-assisted surgery is being implemented on the basis of theoretical advantages, which have yet to be confirmed in practice. Robotic surgery is an expensive health care provision and merits robust evaluation. The ROLARR trial is a pragmatic trial aiming to provide a comprehensive evaluation of both robotic-assisted and standard laparoscopic surgery for the curative resection of rectal cancer.

Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM (2010) GLOBOCAN 2008, cancer incidence and mortality worldwide: IARC CancerBase No. 10. http://globocan.iarc.fr/

American Cancer Society (2010) Cancer facts and figures 2010. http://www.cancer.org/acs/groups/content/@nho/documents/document/acspc-024113.pdf. Accessed on 31 Jan 2011

Guillou PJ, Quirke P, Thorpe H, Walker J, Jayne DG, Smith AM, Heath RM, Brown JM (2005) Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet 365(9472):1718–1726. doi:10.1016/S0140-6736(05)66545-2 PubMedCrossRef

Clinical Outcomes of Surgical Therapy Study Group (2004) A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 350(20):2050–2059. doi:10.1056/NEJMoa032651 CrossRef

Jayne DG, Thorpe HC, Copeland J, Quirke P, Brown JM, Guillou PJ (2010) Five-year follow-up of the Medical Research Council CLASICC trial of laparoscopically assisted versus open surgery for colorectal cancer. Br J Surg 97(11):1638–1645. doi:10.1002/bjs.7160 PubMedCrossRef

Jayne DG, Guillou PJ, Thorpe H, Quirke P, Copeland J, Smith AM, Heath RM, Brown JM (2007) Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group. J Clin Oncol 25(21):3061–3068. doi:10.1200/JCO.2006.09.7758 PubMedCrossRef

Jayne DG, Brown JM, Thorpe H, Walker J, Quirke P, Guillou PJ (2005) Bladder and sexual function following resection for rectal cancer in a randomized clinical trial of laparoscopic versus open technique. Br J Surg 92(9):1124–1132. doi:10.1002/bjs.4989 PubMedCrossRef

Poon JT, Law WL (2009) Laparoscopic resection for rectal cancer: a review. Ann Surg Oncol 16(11):3038–3047. doi:10.1245/s10434-009-0603-5 PubMedCrossRef

Cheung YM, Lange MM, Buunen M, Lange JF (2009) Current technique of laparoscopic total mesorectal excision (TME): an international questionnaire among 368 surgeons. Surg Endosc 23:2796–2801. doi:10.1007/s00464-009-0566-4 PubMedCrossRef

10.

Taylor GW (2007) Minimally Invasive Robotic Association 2nd International Congress: the Union League Club, New York, NY, USA, 18–20 January 2007. Int J Med Robot 3(3):281–286. doi:10.1002/rcs.154 PubMedCrossRef

11.

Corcione F, Esposito C, Cuccurullo D, Settembre A, Miranda N, Amato F, Pirozzi F, Caiazzo P (2005) Advantages and limits of robot-assisted laparoscopic surgery: preliminary experience. Surg Endosc 19(1):117–119. doi:10.1007/s00464-004-9004-9 PubMedCrossRef

12.

Delaney CP, Lynch AC, Senagore AJ, Fazio VW (2003) Comparison of robotically performed and traditional laparoscopic colorectal surgery. Dis Colon Rectum 46(12):1633–1639. doi:10.1097/01.DCR.0000098941.42470.D9 PubMedCrossRef

13.

Wexner SD, Bergamaschi R, Lacy A, Udo J, Brolmann H, Kennedy RH, John H (2009) The current status of robotic pelvic surgery: results of a multinational interdisciplinary consensus conference. Surg Endosc 23(2):438–443. doi:10.1007/s00464-008-0202-8 PubMedCrossRef

14.

MacFarlane JK, Ryall RD, Heald RJ (1993) Mesorectal excision for rectal cancer. Lancet 341(8843):457–460. doi:0140-6736(93)90207-W PubMedCrossRef

15.

Pigazzi A, Ellenhorn JD, Ballantyne GH, Paz IB (2006) Robotic-assisted laparoscopic low anterior resection with total mesorectal excision for rectal cancer. Surg Endosc 20(10):1521–1525. doi:10.1007/s00464-005-0855-5 PubMedCrossRef

16.

Hellan M, Anderson C, Ellenhorn JD, Paz B, Pigazzi A (2007) Short-term outcomes after robotic-assisted total mesorectal excision for rectal cancer. Ann Surg Oncol 14(11):3168–3173. doi:10.1245/s10434-007-9544-z PubMedCrossRef

17.

Rawlings AL, Woodland JH, Crawford DL (2006) Telerobotic surgery for right and sigmoid colectomies: 30 consecutive cases. Surg Endosc 20(11):1713–1718. doi:10.1007/s00464-005-0771-8 PubMedCrossRef

18.

Zimmern A, Prasad L, Desouza A, Marecik S, Park J, Abcarian H (2010) Robotic colon and rectal surgery: a series of 131 cases. World J Surg 34(8):1954–1958. doi:10.1007/s00268-010-0591-4 PubMedCrossRef

19.

Park JS, Choi GS, Lim KH, Jang YS, Jun SH (2010) Robotic-assisted versus laparoscopic surgery for low rectal cancer: case-matched analysis of short-term outcomes. Ann Surg Oncol 17:3195–3202. doi:10.1245/s10434-010-1162-5 PubMedCrossRef

20.

D'Annibale A, Morpurgo E, Fiscon V, Trevisan P, Sovernigo G, Orsini C, Guidolin D (2004) Robotic and laparoscopic surgery for treatment of colorectal diseases. Dis Colon Rectum 47(12):2162–2168. doi:10.1007/s10350-004-0711-z PubMedCrossRef

21.

Baek JH, McKenzie S, Garcia-Aguilar J, Pigazzi A (2010) Oncologic outcomes of robotic-assisted total mesorectal excision for the treatment of rectal cancer. Ann Surg 251(5):882–886. doi:10.1097/SLA.0b013e3181c79114 PubMedCrossRef

22.

Bianchi PP, Ceriani C, Locatelli A, Spinoglio G, Zampino MG, Sonzogni A, Crosta C, Andreoni B (2010) Robotic versus laparoscopic total mesorectal excision for rectal cancer: a comparative analysis of oncological safety and short-term outcomes. Surg Endosc 24:2888–2894. doi:10.1007/s00464-010-1134-7 PubMedCrossRef

23.

Pigazzi A, Luca F, Patriti A, Valvo M, Ceccarelli G, Casciola L, Biffi R, Garcia-Aguilar J, Baek JH (2010) Multicentric study on robotic tumor-specific mesorectal excision for the treatment of rectal cancer. Ann Surg Oncol 17(6):1614–1620. doi:10.1245/s10434-010-0909-3 PubMedCrossRef

24.

Choi DJ, Kim SH, Lee PJ, Kim J, Woo SU (2009) Single-stage totally robotic dissection for rectal cancer surgery: technique and short-term outcome in 50 consecutive patients. Dis Colon Rectum 52(11):1824–1830. doi:10.1007/DCR.0b013e3181b13536 PubMedCrossRef

25.

Patriti A, Ceccarelli G, Bartoli A, Spaziani A, Biancafarina A, Casciola L (2009) Short- and medium-term outcome of robot-assisted and traditional laparoscopic rectal resection. JSLS 13(2):176–183PubMed

26.

Baik SH, Ko YT, Kang CM, Lee WJ, Kim NK, Sohn SK, Chi HS, Cho CH (2008) Robotic tumor-specific mesorectal excision of rectal cancer: short-term outcome of a pilot randomized trial. Surg Endosc 22(7):1601–1608. doi:10.1007/s00464-008-9752-z PubMedCrossRef

27.

Mirnezami AH, Mirnezami R, Venkatasubramaniam AK, Chandrakumaran K, Cecil TD, Moran BJ (2010) Robotic colorectal surgery: hype or new hope? A systematic review of robotics in colorectal surgery. Colorectal Dis 12:1084–1093. doi:10.1111/j.1463-1318.2009.01999.x PubMedCrossRef

28.

Rawlings AL, Woodland JH, Vegunta RK, Crawford DL (2007) Robotic versus laparoscopic colectomy. Surg Endosc 21(10):1701–1708. doi:10.1007/s00464-007-9231-y PubMedCrossRef

29.

Vassiliou MC, Feldman LS, Andrew CG, Bergman S, Leffondre K, Stanbridge D, Fried GM (2005) A global assessment tool for evaluation of intraoperative laparoscopic skills. Am J Surg 190(1):107–113. doi:10.1016/j.amjsurg.2005.04.004 PubMedCrossRef

30.

Smets EM, Garssen B, Cull A, de Haes JC (1996) Application of the multidimensional fatigue inventory (MFI-20) in cancer patients receiving radiotherapy. Br J Cancer 73(2):241–245PubMedCrossRef

31.

Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT (1992) The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol 148(5):1549–1557, discussion 1564PubMed

32.

Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A (1997) The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 49(6):822–830. doi:S0090-4295(97)00238-0 PubMedCrossRef

33.

Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr (2000) The female sexual function index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther 26(2):191–208PubMedCrossRef

34.

Dolan P (1997) Modeling valuations for EuroQol health states. Med Care 35(11):1095–1108PubMedCrossRef

35.

Aziz O, Constantinides V, Tekkis PP, Athanasiou T, Purkayastha S, Paraskeva P, Darzi AW, Heriot AG (2006) Laparoscopic versus open surgery for rectal cancer: a meta-analysis. Ann Surg Oncol 13(3):413–424. doi:10.1245/ASO.2006.05.045 PubMedCrossRef

Title: An international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer
Authors: Fiona J. Collinson
David G. Jayne
Alessio Pigazzi
Charles Tsang
Jennifer M. Barrie
Richard Edlin
Christopher Garbett
Pierre Guillou
Ivana Holloway
Helen Howard
Helen Marshall
Christopher McCabe
Sue Pavitt
Phil Quirke
Carly S. Rivers
Julia M. B. Brown
Publication date: 01-02-2012
Publisher: Springer-Verlag
Published in: International Journal of Colorectal Disease / Issue 2/2012
Print ISSN: 0179-1958
Electronic ISSN: 1432-1262
DOI: https://doi.org/10.1007/s00384-011-1313-6

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

An international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer

Abstract

Purpose

Methods/design

Discussion

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Purpose

Methods/design

Discussion

Please log in to get access to this content

Other articles of this Issue 2/2012

Segmental colitis associated with diverticulosis: a 5-year follow-up

The outcome of initial percutaneous drainage versus surgical drainage for intra-abdominal abscesses in Crohn’s disease

Comparison between quantitative assessment of bowel wall vascularization by contrast-enhanced ultrasound and results of histopathological scoring in ulcerative colitis

Polypoid adenocarcinoma of small bowel in a patient with hereditary nonpolyposis colorectal cancer: does an adjacent gastrojejunostomy have any influence on its development?

E-cadherin (CDH1) gene promoter polymorphism and the risk of colorectal cancer

Successful treatment of an intra-abdominal desmoid tumor with irinotecan, fluorouracil, and leucovorin plus bevacizumab in a patient with familial adenomatous polyposis