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To divert or not to divert after LAR

To divert or not to divert after LAR. John H Marks MD and Rahila Essani MD Chief, Section of Colon and Rectal Surgery Main Line Health System. Introduction. Anastomotic leak is perhaps the most devastating complication after colorectal surgery

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To divert or not to divert after LAR

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  1. To divert or not to divert after LAR John H Marks MD and RahilaEssani MD Chief, Section of Colon and Rectal Surgery Main Line Health System

  2. Introduction • Anastomotic leak is perhaps the most devastating complication after colorectal surgery • Leads to significant morbidity and mortality • Clinical anastomotic leak rate after anterior resection 2.9-19% Rullier et al Br J Surg 1998

  3. Introduction • Reported mortality rate for anastomotic leak 10% to 32% • associated with increased local recurrence and diminished survival • Bokey et al DCR 1995 • Walker et al Ann Surg 2004 • McArdle et al Br J Surg 2005 • Pickleman J et al J Am Coll Surg 1999

  4. Definition of Anastomotic leak • No uniformly accepted definition in the literature. • In a review of 97 studies from 1993 to 1999, 56 differentdefinitions of what constitutes an anastomotic leak were described* * Bruce J et al Br J Surg 2001

  5. Definition of Anastomotic leak

  6. Risk Factors for Anastomotic leak Low Anastomosis and Male * Kingham et al JACS 2008

  7. What about radiation • Only retrospective studies looking at relationship between radiation and leak • Inconclusive data about whether preoperative irradiation leads to higher leak rates • Previous abdominal or pelvic irradiation was a risk for leak on univariate analysis for anastomotic leak, in 707 patients who underwent colorectal resection Inconclusive “data”: but come on…definitely a risk Mortensen et al Best Pract Res Clin Gastroenterol 2004 Alves et al World Journal of Surgery 2002

  8. Defunctioning stoma • Used in up to 73% of rectal cancers • Absence of defunctioning stoma is reported as a risk factor in retrospective reviews • Lower leakage rates have not been demonstrated with defunctioning stoma Heald RJ et al World J Surg 1992 Peeters et al Br J Surg 2005 Gastinger et al Br J Surg 2005

  9. Diversion: Cost to the patient • Routine creation of a stoma will reduce the quality of life in the subgroup in whom no complications would occur • Stoma morbidity is reported to be 30% • Stoma closure leads to second hospital stay and additional costs Gooszen et al Br J Surg 1998 Kooperna et al Arch Surg 2003

  10. Benefit to the patient of diversion • No good long term data on functional results of anastomosis after pelvic sepsis • Multiple studies indicate function better without pelvic sepsis • Increased risk of local and metastatic recurrence after leak Laurent et al J Am Coll Surg 2006

  11. Methods • 1/1996 12/1998- 70 patients in Australia • 19 defunctioning stoma • 51 without stoma • Direct patient care costs -laboratory resources -diagnostic imaging -endoscopy -supplies -drugs -operating room costs + devices in OR

  12. Methods • mean of these costs was calculated per day of hospital and operation time for calculation of cost-effectiveness data • Costs instead of charges were used • Main outcome measure – anastomotic leak rate

  13. Results

  14. Results • Over all major difference in mean costs of treatment between an LAR carried out with or without a defunctioning stoma (€13985 vs €10391; P.001) • mean costs of treatment 5-fold higher with anastomotic leak (€42250) as compared to LAR without a stoma and without leak (€8400; P.001)

  15. Cost Analysis best-case scenario Costeffectiveness ratio of €158705/ leak avoided with defunctioning stoma worst-case scenario 2.5-fold higher overall costs

  16. Methods • Relevant retrospective studies included in the systematic review • RCTs included in meta-analysis reporting -# of clinically relevant anastomotic leaks -# reoperations due to leaks

  17. Systematic review • 1/1966 to 9/ 2007: 70 - 2729 patients • 3 categories of studies on use of stoma -Selective usage -Advocate Routine use -Reject use of stoma

  18. Defunctioning stoma • In non-randomized studies: Selection bias favors surgery without a stoma • Only best patients are not diverted • Selective creation of a stoma when complications are anticipated.

  19. Example Problem: EEA Misfire

  20. Selective stoma Studies Stoma is not recommended use for high risk patients

  21. Studies Rejecting use of Defunctioning stoma higher leak rates in stoma groups routine use of a diverting stoma in LAR is not advisable

  22. Studies Advocating Diversion Stoma prevents clinical leak Stoma protects but doesn’t prevent leak

  23. Conclusion • Included all anterior resections • No clear consensus from non-randomized studies - Due to selection bias

  24. Methods • Only included low anastomoses • Total 26 studies 1983-2008 -22 non-randomized -4 RCTs -1 excluded • Meta-analysis included total 11429 patients

  25. Methods • 4 RCTs -358 patients -178 stoma group -180 non-stoma group • Non-randomized studies -11071 patients -4452 stoma group -6619 non-stoma group

  26. Clinical leak rates in non-randomized studies Significantly lower leak rates in stoma group Meta-analysis of clinical leak rate in stoma versus non-stoma groups in non-randomized studies

  27. Reoperation rates in non-randomized studies Significantly lower in stoma group Meta-analysis of clinical leak rate in stoma versus non-stoma groups in non-randomized studies

  28. Mortality rates in non-randomized studies Significantly higher mortality in non-diverted group Meta-analysis of mortality rate related to leakage in stoma versus non-stoma groups in non-randomized studies

  29. Clinical leak rate in RCT studies Over all higher leak rates in non diverted group All had higher leak rates in non-stoma group but only one statistically significant Meta-analysis of clinical leak rate in stoma versus non-stoma groups in randomized controlled trials

  30. Reoperation rate in RCT studies Over all reoperation rates in non stoma group All had higher reop rates in non-stoma group but only one statistically significant Meta-analysis of reoperation rate in stoma versus non-stoma groups in randomized controlled trials

  31. Mortality rates in RCT studies No significant difference Meta-analysis of mortality rate in stoma versus non-stoma groups in randomized controlled trials

  32. Annals of Surgery Vol 246 August 2007

  33. Methods • 21 hospitals in Sweden participated in the REctal Cancer Trial On DEfunctioning Stoma (RECTODES) Annals of Surgery Vol 246 August 2007

  34. Inclusion criteria • biopsy proven rectal cancer at 15 cm • estimated survival of 6 months • Intraoperative inclusion criteria -anastomosis at 7cm -negative air leak test -intact anastomotic stapler rings -absence of major intraoperative event Randomization intraop Annals of Surgery Vol 246 August 2007

  35. Anastomotic leak • Clinical: -Peritonitis -Rectovaginal fistula -Pelvic abscess without radiologic evidence • Leakage was verified by: -Clinical (digital palpation, inspection of drain contents) -Endoscopic (rigid rectoscopy, flexible sigmoidoscopy) -Radiologicinvestigations (rectal contrast study, CT) • Excluded: -Radiologically proven leak without clinical symptoms Annals of Surgery Vol 246 August 2007

  36. Results • From1999- 2005, 821 Anterior resections performed by 21 hospitals • 234(28.5%) patients randomized -116 defunctiong stoma -118 no stoma Preoperative radiation -79% of 234 • The total rate of symptomatic anastomotic leak was 19.2% (45 of 234 patients)

  37. Results No difference ASA Gender BMI XRT Level

  38. Results Defunctioning stoma 3.4X less likely to have a leak • Leak rate : -10.3% (12/116) defunctioning stoma -28.0% (33/118) no stoma

  39. Results • 40% of the leaks identified after discharge on median POD# 24 (range13-72) • Urgent Reoperation 6% of defunctioning stoma group 23.4% of no stoma group

  40. Results

  41. Conclusions • Presence of defunctioning stoma signficantly decreases anastomotic leak rate • Need for urgent reoperation is increased in non-diverted group Higher leak rate without stoma

  42. Conclusion • Significantly decreased leak and reoperation rates in non-stoma group in both randomized and non-randomized studies • Mortality rates lower in non-stoma group in non-randomized studies only

  43. Two most common risk factors identified - Level of anastomosis - Male sex

  44. Conclusion • The benefits of stoma in decreasing the rate of anastomotic leak and its consequences, should be balanced against the morbidity of the stoma itself

  45. Who should be diverted • Obese • Low anastomsis • Males • Irradiated pelvis

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