- Email: [email protected]
Laparoscopic surgery for rectal cancer
Reflection and Reaction
study, we should compare between tumours that are clinically restaged after pretreatment, and measure the preoperative tumour distance from the pelvic visceral fascia. Without taking these factors into account, Kang and colleagues’ study cannot support the suggestion that laparoscopic surgery is as effective as open surgery with respect to CRM. When comparing the surgical outcomes in Kang and colleagues’ study, knowledge of the technical ability of the surgeons in the open group would be of interest. Finally, in view of the rate of macroscopically complete total mesorectal excisions in the laparoscopy group, would the investigators suggest that surgeons who are faced with a difficult pelvic dissection—ie, when the pelvis is narrow, after pelvic irradiation, with an enlarged prostate, or in obese patients—should close the abdomen and continue the surgery by laparoscopy? Fernando Prete, Francesco Paolo Prete* General Surgery Unit, C Righetti, University of Bari, Bari, Italy (FP); and University College London Hospital, General Surgery and Interventional Sciences, London, UK (FPP) [email protected] The authors declared no conflicts of interest. 1
2
3 4
Kang S-B, Park JW, Jeong S-Y, et al. Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised controlled trial. Lancet Oncol 2010; 11: 637–45. Cawthorn SJ, Parums DV, Gibbs NM, et al. Extent of mesorectal spread and involvement of lateral resection margin as prognostic factors after surgery for rectal cancer. Lancet 1990; 335: 1055–59. Dworak O, Keilholz L, Hoffmann A. Pathological features of rectal cancer after preoperative radiochemotherapy. Int J Colorectal Dis 1997; 12: 19–23. Wieder HA, Rosenberg R, Lordick F, et al. Rectal cancer: MR imaging before neoadjuvant chemotherapy and radiation therapy for prediction of tumor-free circumferential resection margins and long-term survival. Radiology 2007; 243: 744–51.
We congratulate Sung-Bum Kang and colleagues1 for their use of technically demanding laparoscopic surgery for patients with rectal cancer, and producing results that are similar to the conventional open surgery in terms of surgical and pathological completeness. Several randomised trials of laparoscopic surgery in colorectal cancer have attempted to assess the potential benefits of this technique.1,2,3 Although laparoscopic surgery for colorectal cancer seems feasible and safe even in the neoadjuvant setting, the trials have not established any superiority compared with open surgery. Reported benefits in the laparoscopic group—such as decreased time to pass flatus and stools and earlier initiation of oral feeds—are debatable. www.thelancet.com/oncology Vol 11 October 2010
Fast-track protocols have evolved because of improved understanding of the recovery processes after open surgery, and the need to minimise hospital costs to insurance companies, health-care providers, and patients. Various fast-track protocols for colorectal surgery have clearly shown that passage of first flatus or stools might not be an indication of bowel movements, nor should they be used to decide when postoperative feeds should be started.4 Several studies have documented the benefits of laparoscopic surgery compared with open surgery—eg, less postoperative pain, shorter hospital stay, earlier initiation of oral feeds, earlier ambulation, and early return to activity;2,3 however, fast-track colorectal surgery protocols have resulted in shorter hospital stay, even after open surgery. The benefits of laparoscopic surgery should be made available to patients with a high body-mass index, but for both groups in Kang and colleagues’ study, bodymass index was 24·1— ie, in the normal range. The advantages expected of laparoscopic surgery are not apparent in this trial, and the duration of postoperative stay (8 days) in the laparoscopic group (despite a protective diverting ileostomy) seems to be too long. Additionally, differences in the cost implications between the two groups should have been factored. In countries such as India, where medical services are better than in most developing countries, the yearly health-care expenditure per head is $US21.5 The escalated cost of laparoscopic surgery (with no added benefits of a substantially decreased hospital stay) poses a challenge not only to socioeconomically deprived, resource-poor countries6 but also to health-care systems of developed nations. No major randomised trials in laparoscopic colorectal cancer surgery emphasise this challenge.6 In summary, laparoscopy in colorectal cancer surgery has a definite place. However, we now need to develop a system that judiciously selects candidates who would definitely benefit from laparoscopy surgery (compared with open surgery), rather than repeatedly attempting to make laparoscopy a generalised clinical practice guideline via randomised trials. Such a development might halt the ever increasing confusion about the place of laparoscopy in complex gastrointestinal surgery. Shailesh V Shrikhande*, Sachin Marda, Mahesh Goel, Guruprasad Shetty 919
Reflection and Reaction
Tata Memorial Hospital, Gastrointestinal and Hepato-PancreatoBiliary Surgical Oncology, Ernest Borges Marg, Parel, Mumbai, Maharashtra 400 012, India [email protected] The authors declared no conflicts of interest. 1
2
3
4 5 6
Kang S-B, Park JW, Jeong S-Y, et al. Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised controlled trial. Lancet Oncol 2010; 11: 637–45. Buunen M, Veldkamp R, Hop WC, et al, for the Colon Cancer Laparoscopic or Open Resection Study Group. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol 2009; 10: 44–52. Jayne DG, Guillou PJ, Thorpe H, et al, for the UK MRC CLASICC Trial Group. Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group. J Clin Oncol 2007; 25: 3061–68. El Nakeeb A, Fikry A, El Metwally T, et al. Early oral feeding in patients undergoing elective colonic anastomosis. Int J Surg 2009; 7: 206–09. Srinivasan S. Healing people, part I: India on less than $30 a year. World Policy J 2010; 27: 19–20. Künzli BM, Friess H, Shrikhande SV. Is laparoscopic colorectal cancer surgery equal to open surgery? An evidence based perspective. World J Gastrointest Surg 2010; 2: 101–08.
Authors’ reply We thank Francesco and Fernando Prete for their comments. Despite the similar pretreatment clinical stages in our study,1 there were unexpected differences in pathological N classification and tumour regression grade between the laparoscopic group and the open group after neoadjuvant therapy. However, there were no significant differences between the groups in circumferential resection margin (CRM) positivity by ypT status—for patients with ypT0,is,1,2, none of the 95 CRM were positive in the laparoscopic group, compared with one of 71 (1·41%) in the open group (p=0·428); for patients with ypT3,4, five of 75 (6·67%) CRM in the laparoscopic group were positive, compared with six of 99 (6·06%; p=1·000). Likewise, distance from the mesorectal fascia was not affected by ypT status (for patients with ypT0,is,1,2, median distance from mesorectal fascia was 1·0 cm (IQR 0·7–1·3) in the laparoscopic group vs 1·1 cm (0·5–1·3) in the open group, p=0·611; for those with ypT3,4, median distance was 0·6 cm (0·3–1·2) in the laparoscopic group vs 0·7 cm (0·3–1·0) in the open group, p=0·944. Furthermore, CRM positivity and distance from the mesorectal fascia between the groups were also not affected by ypN classification and tumour regression grade (data not shown), suggesting that laparoscopic total mesorectal excision was not inferior to open surgery in terms of CRM quality. Both laparoscopic and open resection were done by all participating surgeons. These surgeons are specialised, 920
and perform surgery principally for colorectal cancer (over 100 cases per year). For difficult pelvic dissections, although we expect possible merits of laparoscopic surgery, we have not yet converted open resection to laparoscopic surgery. We think that conversion to open resection depends on the experience of the surgeon and on oncological safety. Because the outcomes in our trial were produced from procedures that were done by well-trained colorectal surgeons, our results do not prove that laparoscopic rectal resection should be the preferred surgical method for routine use by all surgeons. According to the learning curve of the surgeon, conversion could be chosen after considering the status of patients. We believe that the oncological safety of patients should be the first priority for all, whatever type of surgery is selected. In response to Shailesh Shrikhande and colleagues, our trial did not include fast-track protocols. Some randomised trials2,3 have investigated the effect of such protocols in terms of hospital stay and bowel functional recovery; however, these trials were based on small samples and did not control for tumour location. We should await the outcome of an ongoing, large randomised multicentre study4 for definite evidence of fast-track protocols after laparoscopic or open surgery for colorectal surgery. Shrikhande and colleagues suggest that the expected advantages of laparoscopic surgery, such as decreased duration of postoperative stays in hospital, are not evident in our trial. However, the duration of postoperative stay depends on the differences between medical service systems. In our study, the postoperative stay was long because the Korean medical insurance system is such that hospital stay is inexpensive. With regard to the costs of laparoscopic surgery compared with those for open surgery, the escalated costs of laparoscopic surgery might be resolved with increased experience with this techniques.5 Further, previous studies have shown that laparoscopic surgery was not inferior to open surgery in terms of cost-effectiveness.6,7 We agree that a selection system should be developed for laparoscopic surgery. Jae Hwan Oh*, Sung-Bum Kang, Seung-Yong Jeong, Byung Ho Nam, Ji Won Park Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea (JHO; JWP)
www.thelancet.com/oncology Vol 11 October 2010
study, we should compare between tumours that are clinically restaged after pretreatment, and measure the preoperative tumour distance from the pelvic visceral fascia. Without taking these factors into account, Kang and colleagues’ study cannot support the suggestion that laparoscopic surgery is as effective as open surgery with respect to CRM. When comparing the surgical outcomes in Kang and colleagues’ study, knowledge of the technical ability of the surgeons in the open group would be of interest. Finally, in view of the rate of macroscopically complete total mesorectal excisions in the laparoscopy group, would the investigators suggest that surgeons who are faced with a difficult pelvic dissection—ie, when the pelvis is narrow, after pelvic irradiation, with an enlarged prostate, or in obese patients—should close the abdomen and continue the surgery by laparoscopy? Fernando Prete, Francesco Paolo Prete* General Surgery Unit, C Righetti, University of Bari, Bari, Italy (FP); and University College London Hospital, General Surgery and Interventional Sciences, London, UK (FPP) [email protected] The authors declared no conflicts of interest. 1
2
3 4
Kang S-B, Park JW, Jeong S-Y, et al. Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised controlled trial. Lancet Oncol 2010; 11: 637–45. Cawthorn SJ, Parums DV, Gibbs NM, et al. Extent of mesorectal spread and involvement of lateral resection margin as prognostic factors after surgery for rectal cancer. Lancet 1990; 335: 1055–59. Dworak O, Keilholz L, Hoffmann A. Pathological features of rectal cancer after preoperative radiochemotherapy. Int J Colorectal Dis 1997; 12: 19–23. Wieder HA, Rosenberg R, Lordick F, et al. Rectal cancer: MR imaging before neoadjuvant chemotherapy and radiation therapy for prediction of tumor-free circumferential resection margins and long-term survival. Radiology 2007; 243: 744–51.
We congratulate Sung-Bum Kang and colleagues1 for their use of technically demanding laparoscopic surgery for patients with rectal cancer, and producing results that are similar to the conventional open surgery in terms of surgical and pathological completeness. Several randomised trials of laparoscopic surgery in colorectal cancer have attempted to assess the potential benefits of this technique.1,2,3 Although laparoscopic surgery for colorectal cancer seems feasible and safe even in the neoadjuvant setting, the trials have not established any superiority compared with open surgery. Reported benefits in the laparoscopic group—such as decreased time to pass flatus and stools and earlier initiation of oral feeds—are debatable. www.thelancet.com/oncology Vol 11 October 2010
Fast-track protocols have evolved because of improved understanding of the recovery processes after open surgery, and the need to minimise hospital costs to insurance companies, health-care providers, and patients. Various fast-track protocols for colorectal surgery have clearly shown that passage of first flatus or stools might not be an indication of bowel movements, nor should they be used to decide when postoperative feeds should be started.4 Several studies have documented the benefits of laparoscopic surgery compared with open surgery—eg, less postoperative pain, shorter hospital stay, earlier initiation of oral feeds, earlier ambulation, and early return to activity;2,3 however, fast-track colorectal surgery protocols have resulted in shorter hospital stay, even after open surgery. The benefits of laparoscopic surgery should be made available to patients with a high body-mass index, but for both groups in Kang and colleagues’ study, bodymass index was 24·1— ie, in the normal range. The advantages expected of laparoscopic surgery are not apparent in this trial, and the duration of postoperative stay (8 days) in the laparoscopic group (despite a protective diverting ileostomy) seems to be too long. Additionally, differences in the cost implications between the two groups should have been factored. In countries such as India, where medical services are better than in most developing countries, the yearly health-care expenditure per head is $US21.5 The escalated cost of laparoscopic surgery (with no added benefits of a substantially decreased hospital stay) poses a challenge not only to socioeconomically deprived, resource-poor countries6 but also to health-care systems of developed nations. No major randomised trials in laparoscopic colorectal cancer surgery emphasise this challenge.6 In summary, laparoscopy in colorectal cancer surgery has a definite place. However, we now need to develop a system that judiciously selects candidates who would definitely benefit from laparoscopy surgery (compared with open surgery), rather than repeatedly attempting to make laparoscopy a generalised clinical practice guideline via randomised trials. Such a development might halt the ever increasing confusion about the place of laparoscopy in complex gastrointestinal surgery. Shailesh V Shrikhande*, Sachin Marda, Mahesh Goel, Guruprasad Shetty 919
Reflection and Reaction
Tata Memorial Hospital, Gastrointestinal and Hepato-PancreatoBiliary Surgical Oncology, Ernest Borges Marg, Parel, Mumbai, Maharashtra 400 012, India [email protected] The authors declared no conflicts of interest. 1
2
3
4 5 6
Kang S-B, Park JW, Jeong S-Y, et al. Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised controlled trial. Lancet Oncol 2010; 11: 637–45. Buunen M, Veldkamp R, Hop WC, et al, for the Colon Cancer Laparoscopic or Open Resection Study Group. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol 2009; 10: 44–52. Jayne DG, Guillou PJ, Thorpe H, et al, for the UK MRC CLASICC Trial Group. Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group. J Clin Oncol 2007; 25: 3061–68. El Nakeeb A, Fikry A, El Metwally T, et al. Early oral feeding in patients undergoing elective colonic anastomosis. Int J Surg 2009; 7: 206–09. Srinivasan S. Healing people, part I: India on less than $30 a year. World Policy J 2010; 27: 19–20. Künzli BM, Friess H, Shrikhande SV. Is laparoscopic colorectal cancer surgery equal to open surgery? An evidence based perspective. World J Gastrointest Surg 2010; 2: 101–08.
Authors’ reply We thank Francesco and Fernando Prete for their comments. Despite the similar pretreatment clinical stages in our study,1 there were unexpected differences in pathological N classification and tumour regression grade between the laparoscopic group and the open group after neoadjuvant therapy. However, there were no significant differences between the groups in circumferential resection margin (CRM) positivity by ypT status—for patients with ypT0,is,1,2, none of the 95 CRM were positive in the laparoscopic group, compared with one of 71 (1·41%) in the open group (p=0·428); for patients with ypT3,4, five of 75 (6·67%) CRM in the laparoscopic group were positive, compared with six of 99 (6·06%; p=1·000). Likewise, distance from the mesorectal fascia was not affected by ypT status (for patients with ypT0,is,1,2, median distance from mesorectal fascia was 1·0 cm (IQR 0·7–1·3) in the laparoscopic group vs 1·1 cm (0·5–1·3) in the open group, p=0·611; for those with ypT3,4, median distance was 0·6 cm (0·3–1·2) in the laparoscopic group vs 0·7 cm (0·3–1·0) in the open group, p=0·944. Furthermore, CRM positivity and distance from the mesorectal fascia between the groups were also not affected by ypN classification and tumour regression grade (data not shown), suggesting that laparoscopic total mesorectal excision was not inferior to open surgery in terms of CRM quality. Both laparoscopic and open resection were done by all participating surgeons. These surgeons are specialised, 920
and perform surgery principally for colorectal cancer (over 100 cases per year). For difficult pelvic dissections, although we expect possible merits of laparoscopic surgery, we have not yet converted open resection to laparoscopic surgery. We think that conversion to open resection depends on the experience of the surgeon and on oncological safety. Because the outcomes in our trial were produced from procedures that were done by well-trained colorectal surgeons, our results do not prove that laparoscopic rectal resection should be the preferred surgical method for routine use by all surgeons. According to the learning curve of the surgeon, conversion could be chosen after considering the status of patients. We believe that the oncological safety of patients should be the first priority for all, whatever type of surgery is selected. In response to Shailesh Shrikhande and colleagues, our trial did not include fast-track protocols. Some randomised trials2,3 have investigated the effect of such protocols in terms of hospital stay and bowel functional recovery; however, these trials were based on small samples and did not control for tumour location. We should await the outcome of an ongoing, large randomised multicentre study4 for definite evidence of fast-track protocols after laparoscopic or open surgery for colorectal surgery. Shrikhande and colleagues suggest that the expected advantages of laparoscopic surgery, such as decreased duration of postoperative stays in hospital, are not evident in our trial. However, the duration of postoperative stay depends on the differences between medical service systems. In our study, the postoperative stay was long because the Korean medical insurance system is such that hospital stay is inexpensive. With regard to the costs of laparoscopic surgery compared with those for open surgery, the escalated costs of laparoscopic surgery might be resolved with increased experience with this techniques.5 Further, previous studies have shown that laparoscopic surgery was not inferior to open surgery in terms of cost-effectiveness.6,7 We agree that a selection system should be developed for laparoscopic surgery. Jae Hwan Oh*, Sung-Bum Kang, Seung-Yong Jeong, Byung Ho Nam, Ji Won Park Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea (JHO; JWP)
www.thelancet.com/oncology Vol 11 October 2010