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A COMPARISON of LAPAROSCOPICALLY ASSISTED and OPEN COLECTOMY for COLON CANCER

A COMPARISON of LAPAROSCOPICALLY ASSISTED and OPEN COLECTOMY for COLON CANCER. The Clinical Outcomes of Surgical Therapy Study Group (Cost Study). NEJM, May 13, 2004. BACKGROUND METHODS RESULTS CONCLUSIONS EVIDENCE BASED MEDICINE Ranking of the Study. BACKGROUND.

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A COMPARISON of LAPAROSCOPICALLY ASSISTED and OPEN COLECTOMY for COLON CANCER

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  1. A COMPARISON of LAPAROSCOPICALLY ASSISTED and OPEN COLECTOMY for COLON CANCER The Clinical Outcomes of Surgical Therapy Study Group (Cost Study) NEJM, May 13, 2004

  2. BACKGROUND • METHODS • RESULTS • CONCLUSIONS • EVIDENCE BASED MEDICINE • Ranking of the Study

  3. BACKGROUND

  4. Phillips, Ann, Surg, 1992 First to report laparoscopic approach to colectomy for colon cancer in 24 patients Berends, Lancet, 1994 Reported 3 of 14 patients developed trocar wound site recurrences in series of laparoscopically assisted resections for colon cancer.

  5. Reilly, Disease Colon Rectum, 1996 Reported less than 1% wound site recurrences following laparoscopically assisted resections for colon cancer.

  6. Questions Raised • Could a proper oncologic resection be performed with the laparoscopic approach? • Were there staging inaccuracies with the laparoscopic approach? • Were patterns of tumor cell dissemination altered by the laparoscopic approach?

  7. Questions Raised • Were wound site recurrence rates truly higher with the laparoscopic approach? • Were overall recurrence rates higher with the laparoscopic approach? • Were disease free and overall survival rates lower with the laparoscopic approach?

  8. Questions Raised • Were post operative complication rates higher with the laparoscopic approach? • Was post operative recovery faster with the laparoscopic approach?

  9. COST STUDY • Initiated in 1994 to ensure that the laparoscopic approach to colon cancer was properly tested before its use became wide spread. • Surgeons generally adopted a virtual moratorium on laparoscopic resection for colon cancer outside of this trial.

  10. METHODS

  11. Design • Noninferiority trial • Prospective randomized trial • Involved 66 credentialed surgeons from 48 institutions in the USA and Canada. • Compared laparoscopic vs open approach to colon cancer

  12. Patients • Inclusion Criteria • 18 years of age or older • Diagnosed clinically with colon adenocarcinoma and had histologic confirmation at surgery • Right or left colon cancer

  13. Patients • Exclusion Criteria • Pregnancy • Inflammatory bowel disease • Familial polyposis • Previous malignant tumor • Current malignant tumor • Severe medical illness • Prohibitive abdominal adhesions

  14. Patients • Exclusion Criteria • Transverse colon cancer • Rectal cancer • Acute bowel obstruction • Perforation from cancer • Advanced local disease • Metastatic disease

  15. Quality Control • 66 credentialed surgeons at 48 institutions • Each surgeon was required to have had performed at least 20 laparoscopically assisted colorectal surgeries prior to entry into the trial

  16. Quality Control • Prior to entry into trial, each surgeon submitted a videotape of a laparoscopic colectomy that was reviewed for: • thoroughness of abdominal exploration • identification of critical adjacent structures • oncologic techniques • degree of avoidance of direct tumor handling • level of mesenteric ligation

  17. Quality Control • Random audits of videotapes during trial • Assessment of bowel resection margins during trial

  18. TECHNIQUE OF LAPAROSCOPIC COLON RESECTION • Pneumoperitoneal/ intracorporeal approach to: • abdominal exploration • mobilization of colon • identification of critical structures • ligation of vascular pedicles • Exteriorization of bowel through small incision for resection/ anastomosis

  19. INDICATIONS FOR COVERSION FROM LAPAROSCOPIC TO OPEN SURGERY • Presence of associated conditions • Findings of advanced disease • Massive adhesions • Technical difficulties • Inadequate oncologic margins • Surgeons descretion for patient safety

  20. Adjuvant chemotherapy was allowed at the physicians or patient’s descretion

  21. RANDOMIZATION • Performed centrally at the North Central Cancer Treatment Group statistical office • Patients randomly assigned to: • laparoscopically assisted colectomy • open laparotomy and colectomy

  22. RANDOMIZATION • Through use of minimization algorithm, treatment assignment was balanced with respect to three stratification variables: • surgeon • primary tumor site – right, left, sigmoid

  23. RANDOMIZATION • American Society of Anesthesiologists Class • Class I – patient appears healthy • Class II – patient has systemic, well controlled disease • Class III – patient has multiple symptoms of disease, or well controlled major system disease

  24. FOLLOW – UP: • COMPLICATIONS • Assessed by single reviewer • Reviewer unaware of patient’s treatment assignment • Assessed at date of discharge, 2 months, and 18 months

  25. Follow – UpClassification of Complications

  26. FOLLOW – UP: • TUMOR RECURRENCE • Physical exam including inspection of wound sites • CEA every 3 months for first year, then every 6 months for 5 years • CxR every 6 months for 2 years, then every year • Colonoscopy, or proctosigmoidoscopy and barium enema every 3 years • Recurrence had to be confirmed with imaging or endoscopy

  27. STATISTICAL ANALYSIS • Designed to compare the following end points in the laparoscopic vs the open colectomy groups: • Primary end point • Time to tumor recurrence defined as the time from randomization to first confirmed recurrence • Secondary end points • Variables related to recovery • Complications • Disease free survival • Overall survival

  28. RESULTS

  29. Characteristics of Patients and Tumors • 872 patients underwent randomization from August 1994 to August 2001 over 7 years • 2 patients subsequently declined surgery • 7 patients subsequently were ineligible • This left 863 patients for final analysis

  30. Characteristics of Patients and Tumors Age

  31. Characteristics of Patients and Tumors Sex

  32. Characteristics of Patients and Tumors

  33. Characteristics of Patients and Tumors

  34. Characteristics of Patients and Tumors

  35. Characteristics of Patients and Tumors

  36. Characteristics of Patients and Tumors Grade of Differentiation

  37. Characteristics of Patients and Tumors Depth of Invasion

  38. Characteristics of Patients and Tumors

  39. SURGERY • Total Surgery Patients • Total patients 863 • Open colectomy 428 (49.6%) • Laparoscopic Colectomy 435 (50.4%) • Successful laparoscopic colectomy 345 (79%) • Converted to open colectomy 90 (21%)

  40. SURGERY • Reasons for conversion# of patients • Advanced disease 22 (24%) • Other 21 (23%) • Adhesions 14 (16%) • No visualization 12 (13%) • of critical structures • Unable to mobilize colon 10 (11%) • Complicating disease 3 (3%) • Inadequate resection margins 4 (4%) • Intraoperative complications 4 (4%)

  41. SURGERY Conversion Rates P Value High vs low volume surgeons >0.05 Early vs late trial entry surgeons >0.05

  42. SURGERY

  43. SURGERY

  44. SURGERY

  45. SURGERY

  46. RECOVERY

  47. Complications

  48. Complications

  49. Complications

  50. RECURRENCE (after median follow-up of 4.4 years)

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