Laparoscopic Appendectomy Overrated. University of Colorado Department of Surgery Grand Rounds November 20, 2006 Carlos Rueda M.D.

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1 Laparoscopic Appendectomy Overrated University of Colorado Department of Surgery Grand Rounds November 20, 2006 Carlos Rueda M.D.

2 Appendicitis 6-8% of population over lifetime Surgical Treatment 250,000 per year in United States Laparoscopic vs. Open Appendectomy

3 Open Appendectomy First done in 1894 by Dr. Charles McBurney Surgical procedure remained unchanged for nearly a century.

4 Laparoscopic Appendectomy First done in 1983 by a German Gynecologist Dr. Kurt Semm New technique has only partly gained acceptance

5 Introduction: Cochrane Review Review comparing laparoscopic and conventional surgery with regard to several variables. Searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, SciSearch. 54 studies were examined. 45 studies compared LA vs. OA in adults 5 studies compared LA vs. OA in children Sauerland S, et al. Laparoscopic versus open surgery for suspected appendicitis. Cochrane Database of Systemic Reviews 2004, Issue 4.

6 Results: Cochrane Review Therapeutic effects in adults Wound infection half as likely after LA than OA (OR 0.45; 95%-CI ) 0.58) Intraabdominal abscesses increased nearly threefold after LA (OR 2.48; 95%-CI 1.45 to 4.21) OR time increased by 12 minutes in LA (95%-CI 7 to 16) Pain on day 1 after surgery showed a reduction of pain by 9mm on a 100mm visual analog scale (95%-CI 5 to 13mm) Hospital stay reduction of 1.1 days after LA (95%-CI 0.6 to 1.5) Hospital costs were significantly higher in LA vs. OA Sauerland S, et al. Laparoscopic versus open surgery for suspected appendicitis. Cochrane Database of Systemic Reviews 2004, Issue 4.

7 Results: Cochrane Review Therapeutic effects in children Wound infection significantly reduced after LA (OR 0.20; 95%-CI 0.08 to 0.54) Only 3 intraabdominal abscesses were observed in 3 out of 5 trials OR time increased by 11 minutes in LA (95%-CI 6 to 16) Shoulder tip pain was more frequent in LA, and one trial failed to show reduction in pain (Lintula 2004) Hospital stay reduction significantly decreased after LA (OR % 0.3 to 1.1) Hospital costs were significantly higher in LA vs. OA (OR %-CI Sauerland S, et al. Laparoscopic versus open surgery for suspected appendicitis. Cochrane Database of Systemic Reviews 2004, Issue 4.

8 Conclusion: Cochrane Review What is of clinical relevance? Wound infections less common in LA, but IAA more common. Can we justify avoiding 3 wound infections but accepting 1 IAA more in return? Pain reduction by 9 mm on a 100 mm VAS has been shown to be under the level of pain that an average patient is able to perceive. Statistically significant yes, but clinically relevant? LA has undoubtedly higher hospital costs, but somewhat quicker recovery and shorter hospital stay. Hospital stay data reported was surprisingly long after OA. Hospitalization depended more on tradition than on clinical needs. Sauerland S, et al. Laparoscopic versus open surgery for suspected appendicitis. Cochrane Database of Systemic Reviews 2004, Issue 4.

9 Introduction: Meta-Analysis in Children Compared laparoscopic and open appendectomy in a pediatric population Studies between 1992 and 2004 Examined four complications: postoperative fever, ileus, wound infection and intraabdominal abscesses formation. 23 studies analyzed, included almost 6500 kids, including 6 randomized control trials 43% had laparoscopic appendectomy 57% had open appendectomy Aziz O, et al. Laparoscopic versus open appendectomy in children. Annals of Surgery 2006;246:

10 Results: Meta-Analysis in Children Wound infection in all studies was significantly different. RCT: LA 1.5% vs. OA 4.9%. Not statistically significant IAA formation of all studies did not show a significant difference. RCT: LA 7.4% vs. OA 4.2% (OR %-CI 1.0 to 2.87) Marginally NSS Postop ileus in all studies significantly reduced in LA. RCT: LA 2.9% vs. OA 3.4%. Not statistically significant Postop fever of all studies no significant difference Aziz O, et al. Laparoscopic versus open appendectomy in children. Annals of Surgery 2006;246:

11 Results: Meta-Analysis in Children Hospital stay significantly reduced in LA Operative time did not show a significantly greater length of operation in LA vs. OA. Cost of hospital stay for LA $5,801 (±$1,776)( for OA $4734 (±$2,199)( Aziz O, et al. Laparoscopic versus open appendectomy in children. Annals of Surgery 2006;246:

12 Conclusion: Meta-Analysis in Children Wound infection rate is better in LA There were more IAA in the LA group when analyzed with RCT only. Although this was not statistically significant, is it clinically relevant? Analysis did not match for the severity of appendicitis. The more severe cases may have undergone OA. Finally length of hospital stay was reduced by 0.48 days. Statistically significant yes, but is it clinically relevant at the expense of more than $1,000 difference and increased risk of IAA? Besides Aziz O, et al. Laparoscopic versus open appendectomy in children. Annals of Surgery 2006;246:

13 Real men do open appendectomies and use ether!

14 Introduction: Double Blind Randomized Trial Prospective Randomized Study comparing LA to OA, included double blinding of the patient and the independent data collector 247 patients analyzed with similar characteristics in both groups Surgical technique was standardized among 4 surgeons Main outcomes measure was post-operative operative complications Secondary outcome measures included evaluation of pain, return to regular activity, resumption of diet and length of hospital stay Katkhouda N, et al. Laparoscopic versus open appendectomy: A prospective randomized double-blind blind Study. Annals of Surgery 2005;242:

15 Results: Double Blind Randomized Trial Wound infections LA 6.2% vs. OA 6.7%, no significant statistical difference. IAA formation LA 5.3% vs. OA 3%, no significant statistical difference Katkhouda N, et al. Laparoscopic versus open appendectomy: A prospective randomized double-blind blind Study. Annals of Surgery 2005;242:

16 Conclusion: Double Blind Randomized Trial LA is not superior to OA Infectious complications showed no statistical difference. Possibly from insufficient sample size (Type 2 Error) The authors do not recommend laparoscopic appendectomy for perforated appendicitis, in agreement with other authors (Paik, et al; 1997) Secondary outcome measures were not statistically different except for length of procedure in favor of OA. Therefore LA is overrated. Katkhouda N, et al. Laparoscopic versus open appendectomy: A prospective randomized double-blind blind Study. Annals of Surgery 2005;242:

17 SAGES Society of American Gastrointestinal Endoscopic Surgeons th World Congress of Endoscopic Surgery meeting, NY, March th Appropriateness conference related to lap or open techniques in four topics including appendectomy Glasgow R, et al. SAGES appropriateness conference: A summary. Surgical Endoscopy. 2003;17:

18 SAGES Level of evidence Ia (Meta-analysis analysis or RCT) Wound infections when intention-to to-treat treat analysis is used, the LA advantage is diminished Reduction in the 1 st postop day pain based on VAS Two to threefold increase in the deep abscess rate associated with LA Glasgow R, et al. SAGES appropriateness conference: A summary. Surgical Endoscopy. 2003;17:

19 SAGES Level of evidence Ia (Meta-analysis analysis or RCT) Wound infections when intention-to to-treat treat analysis is used, the LA advantage is diminished Reduction in the 1 st postop day pain based on VAS Two to threefold increase in the deep abscess rate associated with LA Glasgow R, et al. SAGES appropriateness conference: A summary. Surgical Endoscopy. 2003;17:

20 IAA After Lap Appy

21 Introduction: LA in Denver Retrospective analysis of LA and OA cases over one year 247 patients included LA 95 patients vs. OA 152 patients No significant differences between laparoscopic or open groups Charge comparison was conducted Cothren C, et al. Can we afford to do laparoscopic appendectomy in an academic hospital. The American Journal of Surgery 2005;190:

22 Results: LA in Denver No statistical difference in operative minutes, operating room minutes, or hospital length of stay Significantly different hospital charges Cothren C, et al. Can we afford to do laparoscopic appendectomy in an academic hospital. The American Journal of Surgery 2005;190:

23 Conclusions: LA in Denver Unless patient factors warrant a laparoscopic approach, we submit open appendectomy remains the most cost effective procedure in an academic environment. Authors concluded that DHMC would have saved over $800,000 in charges over the year. Considering that the length of stay was similar in both groups the offset in charges from an earlier discharge after LA is not observed. Cothren C, et al. Can we afford to do laparoscopic appendectomy in an academic hospital. The American Journal of Surgery 2005;190:

24 Who should have a lap appy? SAGES Appropriateness Conference In fertile women, laparoscopy improves the diagnostic accuracy when compared with the open approach (Strength of evidence Ib; from at least one RCT) In obese patients (BMI > 26) a laparoscopic approach may be beneficial. But the appropriateness of laparoscopy to diagnose appendicitis in non-obese obese young men has not been demonstrated. The benefits of LA in the pediatric population remain controversial. Glasgow R, et al. SAGES appropriateness conference: A summary. Surgical Endoscopy. 2003;17:

25 Conclusion Why advocates feel LA is better? Improved wound infections rates? Well, when an intention-to to- treat analysis is conducted this advantage diminishes.

26 Conclusion Why advocates feel LA is better? Improved wound infections rates? Well, when an intention-to to- treat analysis is conducted this advantage diminishes. Improved 1 st post-operative operative day pain? The difference is under the level of pain that an average patient is able to perceive.

27 Conclusion Why advocates feel LA is better? Improved wound infections rates? Well, when an intention-to to- treat analysis is conducted this advantage diminishes. Improved 1 st post-operative operative day pain? The difference is under the level of pain that an average patient is able to perceive. Improved hospital length of stay? Numerous studies document otherwise, LA and OA post-op op patients have similar length of stay.

28 Conclusion Why advocates feel LA is better? Improved wound infections rates? Well, when an intention-to to- treat analysis is conducted this advantage diminishes. Improved 1 st post-operative operative day pain? The difference is under the level of pain that an average patient is able to perceive. Improved hospital length of stay? Numerous studies document otherwise, LA and OA post-op op patients have similar length of stay. Improved cosmesis? Wound healing and scarring are processes that require weeks and months.

29 Conclusion Why advocates feel LA is better? Improved wound infections rates? Well, when an intention-to to- treat analysis is conducted this advantage diminishes. Improved 1 st post-operative operative day pain? The difference is under the level of pain that an average patient is able to perceive. Improved hospital length of stay? Numerous studies document otherwise, LA and OA post-op op patients have similar length of stay. Improved cosmesis? Wound healing and scarring are processes that require weeks and months. Improved time to re-introduction of diet? The Cochrane review has a miniscule advantage over OA. The recent double blind randomized trial found no difference.

30 Conclusion Why is laparoscopic appendectomy overrated? Two to threefold increase in intraabdominal abscess requiring further surgical intervention or antibiotic treatment.

31 Conclusion Why is laparoscopic appendectomy overrated? Two to threefold increase in intraabdominal abscess requiring further surgical intervention or antibiotic treatment. Lack of recent randomized trials for perforated appendectomies. Older trials indicate that it may not be as safe as currently believed.

32 Conclusion Why is laparoscopic appendectomy overrated? Two to threefold increase in intraabdominal abscess requiring further surgical intervention or antibiotic treatment. Lack of recent randomized trials for perforated appendectomies. Older trials indicate that it may not be as safe as currently believed. No significant clinical improvement in hospital stay, return to activity, resumption of diet, postoperative ileus, postoperative fever, or number of days on pain medication needed.

33 Conclusion Why is laparoscopic appendectomy overrated? Two to threefold increase in intraabdominal abscess requiring further surgical intervention or antibiotic treatment. Lack of recent randomized trials for perforated appendectomies. Older trials indicate that it may not be as safe as currently believed. No significant clinical improvement in hospital stay, return to activity, resumption of diet, postoperative ileus, postoperative fever, or number of days on pain medication needed. Significant hospital charges. In indigent patients, these charges go directly to the tax payers. In insured patients, these charges are eventually passed to those paying the premiums or have higher co- pays.

34 Conclusion Why is laparoscopic appendectomy overrated? Two to threefold increase in intraabdominal abscess requiring further surgical intervention or antibiotic treatment. Lack of recent randomized trials for perforated appendectomies. Older trials indicate that it may not be as safe as currently believed. No significant clinical improvement in hospital stay, return to activity, resumption of diet, postoperative ileus, postoperative fever, or number of days on pain medication needed. Significant hospital charges. In indigent patients, these charges go directly to the tax payers. In insured patients, these charges are eventually passed to those paying the premiums or have higher co- pays. Finally, I ask you

35 Why use chopsticks

36 to take this out

37 when you can use

38 real surgical instruments!