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CURRENT STATUS OF LAPAROSCOPY FOR COLORECTAL DISORDERS. Steven D. Wexner, M.D., FACS, FRCS, FRCS(Ed) Cleveland Clinic Florida Chairman, Department of Colorectal Surgery Professor of Surgery, Ohio State University Health Sciences Center at the Cleveland Clinic Foundation
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CURRENT STATUS OF LAPAROSCOPY FOR COLORECTAL DISORDERS Steven D. Wexner, M.D., FACS, FRCS, FRCS(Ed) Cleveland Clinic Florida Chairman, Department of Colorectal Surgery 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
Laparoscopy: Colorectal cancer • Short term benefits • Bowel function recovery • Quality of life (including pain) • Hospital stay • Costs • Long term benefits • Recurrence • Survival
I Evidence obtained from at least one properly randomized controlled trial II-1 Evidence obtained from well-designed controlled trials without randomization II-2 Evidence obtained from well-designed cohort or case control analytic studies, preferable from more than one center or research group II-3 Evidence obtained from comparisons between times or places with or without the intervention; dramatic results in uncontrolled experiments were also included in this category III Opinion of respected authorities based on clinical experience, descriptive studies, or reports of expert committees Laparoscopy: Colorectal cancer Levels of evidence* *Can Med Assoc, 1979
Laparoscopy: Colorectal cancerBowel Function Recovery Case-control/Cohort p<0.05
Laparoscopy: Colorectal cancerBowel Function Recovery Randomized p<0.05
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)
Laparoscopy: Colorectal cancerQuality of Life - Pain Case-control/Cohort
Laparoscopy: Colorectal cancerQuality of Life - Pain Randomized
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
Results P=NS Weeks, JAMA 2002
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
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
Laparoscopy: Colorectal cancerHospital Stay Cohort/case-control studies p<0.05
Laparoscopy: Colorectal cancerHospital Stay Cohort/case-control studies (cont) p<0.05
Laparoscopy: Colorectal cancerHospital Stay Randomized p<0.05
Laparoscopy: Colorectal cancerHospital stay • There is high evidence (Level I) that laparoscopy for malignancy is associated with an earlier discharge compared to laparotomy
Laparoscopy: Colorectal cancerCosts • Retrospective study (Australian $) Philipson, Wold J Surg 1997
Laparoscopy: Colorectal cancerCosts • Retrospective study Khalili, DCR 1998
Laparoscopy: Colorectal cancerCosts • Retrospective study Values are mean (s.d) Psaila, Br J Surg 1998
Laparoscopy: Colorectal cancerCosts • The data available does not provide adequate evidence on whether total costs differ between laparoscopy and laparotomy in the treatment of malignancy
Laparoscopy: Colorectal cancerRecurrence Cohort/case-control studies p=NS
Laparoscopy: Colorectal cancerSurvival Cohort/case-control studies
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
Laparoscopy: Colorectal cancerRecurrence Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancerSurvival Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancerPredictive factors Cox’s regression model Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancerOverall survival Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancerCancer-related survival Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancerRecurrence free – by Stage Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancerOverall survival- by Stage Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancerCancer related survival – by Stage Lacy et al, The lancet 2002
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
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
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
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
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
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
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
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
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
Laparoscopic Colectomy : Prospective, Randomized, Controlled 48 institutions, 872 patients Prospective, randomized Follow-up 4.4 years Conversion 21% Endpoint was time to tumor recurrence Nelson, NEJM 2004
Prospective, Randomized, Controlled Nelson, NEJM 2004
Prospective, Randomized, Controlled: Outcome at Surgery Nelson, NEJM 2004
Prospective, Randomized, Controlled: Post-operative Nelson, NEJM 2004
Prospective, Randomized, Controlled: Outcome *Laparoscopic procedure not significantlyinferior to Open Procedure. Nelson, NEJM 2004