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Current Status of Laparoscopy for Colon and Rectal Cancer

Current Status of Laparoscopy for Colon and Rectal Cancer. Chairman, Department of Colorectal Surgery 21st Century Oncology Chair in Colorectal Surgery Chief of Staff Cleveland Clinic Florida Professor of Surgery, Ohio State University Health Sciences Center at the

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Current Status of Laparoscopy for Colon and Rectal Cancer

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  1. Current Status of Laparoscopy for Colon and Rectal Cancer Chairman, Department of Colorectal Surgery 21st Century Oncology Chair in Colorectal Surgery Chief of Staff Cleveland Clinic Florida Professor of Surgery, Ohio State University Health Sciences Center at the Cleveland Clinic Foundation Clinical Professor of Surgery, University of South Florida College of Medicine Clinical Professor of Biomedical Science Department of Biomedical Science Florida Atlantic University College of Medicine Steven D Wexner, MD, FACS, FRCS, FRCS (Ed) Dan Enger Ruiz, MD David Vivas, MD Clinical Research Fellows

  2. Laparoscopy: Colorectal cancer • Short term benefits • Bowel function recovery • Quality of life (including pain) • Hospital stay • Costs • Long term benefits • Recurrence • Survival

  3. Laparoscopy: Colorectal cancerBowel Function Recovery Randomized p<0.05

  4. Laparoscopy: Colorectal cancerBowel Function Recovery • The evidence that laparoscopy offers faster bowel function recovery than the traditional open approach may be considered high (Level I)

  5. Laparoscopy: Colorectal cancerQuality of Life - Pain Randomized

  6. Laparoscopy: Colorectal cancerQuality of life • Randomized trial (COST trial) • 449 patients • 228 Laparoscopy (Lap) , 221Open • Pain, hospital stay • Quality of life (2 days, 2 weeks, 2 months) • Symptom distress scale • Quality of life index • Global rating scale (1-100) Weeks, JAMA 2002

  7. Results P = N.S. Weeks, JAMA 2002

  8. Results Values are means • Patients in the Lap group had only greater mean global rate scores at 2 weeks after surgery (76.9 vs. 74.4; p=.0009) • No other differences in quality of life Weeks, JAMA 2002

  9. Laparoscopy: Colorectal cancer • The superiority of laparoscopy in reducing pain during the same length of the postoperative period seems evident (Level I) • Other aspects of quality of life warrant further investigation

  10. Laparoscopy: Colorectal cancerHospital Stay Randomized p<0.05

  11. Laparoscopy: Colorectal cancerHospital stay • There is high evidence (Level I) that laparoscopy for malignancy is associated with an earlier discharge compared to laparotomy

  12. Laparoscopy: Colorectal cancerCost • Randomized, prospective trial • Subset of patients from the Swedish COLOR trial • Study period – 12 weeks after surgery • Analysis of direct medical cost (hospital and outpatient) and indirect cost (loss of productivity) Janson, BJS 2004

  13. Laparoscopy: Colorectal cancerCost Prospective, Randomized - COLOR Janson, BJS 2004 All costs in Euros

  14. Laparoscopy: Colorectal cancerCost Prospective, Randomized - COLOR Janson, BJS 2004

  15. Laparoscopy: Colorectal cancerCost • Total cost to society similar in both groups • Direct costs to healthcare system much higher for LCR • Higher OR cost • Cost of complications and reoperation which happened more often in LCR • Same length of stay in both (9 days) • Faster recovery and return to work offset higher healthcare system cost Janson, BJS 2004

  16. Laparoscopy: Colorectal cancerCosts • The data available do not provide adequate evidence on whether total costs significantly differ between laparoscopy and laparotomy in the treatment of malignancy. Costs may significantly vary depending on the healthcare system

  17. Laparoscopy: Colorectal cancerRandomized Controlled Trial • 111 Laparoscopy vs. 106 Laparotomy • Non metastatic colon cancer • Median follow-up time: 43 (27-85) months • Postoperative chemotherapy for all suitable patients with Stage II or III rectal cancer • Intention-to-treat analysis Lacy et al, The Lancet 2002

  18. Laparoscopy: Colorectal cancerRecurrence Lacy et al, The Lancet 2002

  19. Laparoscopy: Colorectal cancerSurvival Lacy et al, The Lancet 2002

  20. Laparoscopy: Colorectal cancerPredictive factors Cox’s regression model Lacy et al, The Lancet 2002

  21. Laparoscopy: Colorectal cancerOverall survival Lacy et al, The Lancet 2002

  22. Laparoscopy: Colorectal cancerCancer-related survival Lacy et al, The Lancet 2002

  23. Laparoscopy: Colorectal cancerRecurrence free – by Stage Lacy et al, The Lancet 2002

  24. Laparoscopic Colectomy: Cancer • Laparoscopic resection of colorectal malignancies • a systematic review • English language • Randomized controlled trials • Controlled clinical trials • Case series/reports Chapman et al. Ann Surg 2001

  25. Laparoscopic Colectomy : Cancer • 52 papers met inclusion criteria • “Little high level evidence was available” • “The evidence base for laparoscopic-assisted reection of colorectal malignancies is inadequate to determine the procedures safety and efficacy” Chapman et al. Ann Surg 2001

  26. Laparoscopic Colectomy : CancerDisadvantages vs. Open Colectomy • Significantly longer operative times • Possibly more expensive • Possibly worse short term immune effects Chapman et al. Ann Surg 2001

  27. Laparoscopic Colectomy : Cancer • “Laparoscopic resection of colorectal malignancy was more expensive and time-consuming” • The new procedure’s advantages revolve around early recovery from surgery and reduced pain” Chapman et al. Ann Surg 2001

  28. Laparoscopic Colectomy : CancerAdvantages vs. Open Colectomy • Improved cosmesis (no data but appears uncontentious) • Quicker hospital discharge • Less narcotic use, though possibly larger benefits for certain types of colectomy (low colonic) • Possibly less pain at rest, at least for patients who have uncovered procedures • Possibly earlier return of bowel function and resumption of normal diet Chapman et al. Ann Surg 2001

  29. Laparoscopic Colectomy : Cancer • Short term Quality-of-Life outcomes Following Laparoscopic-Assisted Colectomy vs Open Colectomy for Colon Cancer (COST Study) • AIMS • Are disease free and overall survival equivalent ? • Is laparoscopic approach associated with better QOL ? Weeks et al. JAMA 2002

  30. Laparoscopic Colectomy : Cancer • Randomized control trial • 449 patients • Adenocarcinoma of single segment of colon • Excluded: Acute presentation, rectal and transverse colon cancers, advanced local disease, those lesions with evidence of metastatic disease, ASA IV or V • Quality of surgery: • All surgeons with > 20 cases; Random audit of cases Weeks et al. JAMA 2002

  31. Laparoscopic Colectomy : Cancer • Outcomes: • Survival: still pending • QOL at 2days, 2 weeks and 2 months using: • Symptom Distress Scale, Global QOL Scale, QOL index • Results: Intention to Treat Analysis • Shorter use of narcotics • Shorter length of stay by 0.8 days (p<0.01) • Quality of life: no difference Weeks et al. JAMA 2002

  32. Laparoscopic Colectomy : Cancer • Conclusions • “The modest benefits in short term QOL measures we observed are not sufficient to justify the use of this procedure in the routine care setting” • Unresolved Issues: • Blunting of QOL differences via analgesic use • QOL differences between POD 2 and POD 14 • Recurrence and survival outcomes • Incidence of small bowel obstruction Weeks et al. JAMA 2002

  33. Laparoscopic Colectomy : Prospective, Randomized, Controlled • 48 institutions, 872 patients • Prospective, randomized • Follow-up 4.4 years • Conversion 21% • End point was time to tumor recurrence Nelson, NEJM 2004

  34. Prospective, Randomized, Controlled Nelson, NEJM 2004

  35. Prospective, Randomized, Controlled: Outcome at Surgery Nelson, NEJM 2004

  36. Prospective, Randomized, Controlled: Post-operative Nelson, NEJM 2004

  37. Prospective, Randomized, Controlled: Outcome *Laparoscopic procedure not significantlyinferior to Open Procedure. Nelson, NEJM 2004

  38. Cumulative Incidence of Recurrence at Any Satge

  39. Overall Survival at Any Stage

  40. Prospective, Randomized, Controlled: Conclusions • No difference between: • Time to recurrence • Disease-free survival • Overall survival • Oncologic outcome of laparoscopic resection is similar to that of open resection • Laparoscopic approach is associated with less pain and a shorter hospital stay than conventional surgery Nelson, NEJM 2004

  41. Laparoscopic Colectomy : CLASICC Trial Colon and Rectal Cancer • 27 UK institutions, 794 patients • Prospective, randomized, controlled • Follow-up at 1 and 3 months • 29% conversion rate Guillou, Lancet 2005

  42. Laparoscopic ColectomyCLASICC Trial Colon and Rectal Cancer • Positivity rates of circumferential and longitudinal resection margins • Proportion of Dukes’ C2 tumors • In-Hospital mortality Primary Endpoints • Complication rates • Quality of life • Transfusion requirments Secondary Endpoints Guillou, Lancet 2005

  43. CLASICC Trial Profile Guillou, Lancet 2005

  44. Prospective, Randomized, Controlled Guillou, Lancet 2005

  45. CLASICC: Outcome at Surgery All data are median Guillou, Lancet 2005

  46. CLASICC: Pathology P>0.05 Guillou, Lancet 2005

  47. CLASICC: Complications P > 0.05 Guillou, Lancet 2005

  48. CLASICC: Complications P>0.05 Guillou, Lancet 2005

  49. CLASICC: Conversions Guillou, Lancet 2005

  50. Laparoscopic Colectomy : Prospective, Randomized, Controlled Outcome at 3 years Equivalent in terms of recurrence and survival Kaiser, J Lap and Advanced Surg Tech 2004

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