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• W2079236105 abstract "I welcome this opportunity to point out that what I actually wrote was that “the technique of laparoscopy is known to be safe” (which it most surely is as evidenced by >20 years of use). I did not write that any particular laparoscopic operation was safe, certainly not laparoscopic cholecystectomy as Grimes1 impliedor laparoscopic hysterectomy as Chandler now does. Chandler takes so many contradictory positions that I am left wondering if even he knows what his real beliefs are. He questions the safety of laparoscopy but advocates laparoscopic cholecystectomy as the standard of care. He rebukes me for questioning the need to study laparoscopic surgery with randomized trials, yet he has concluded without a randomized trial that the morbidity of cholecystectomy is reduced dramatically if the operation is performed laparoscopically. He glowingly endorses the position of Grimes, that there is an “epidemic of surgical morbidity and mortality related to laparoscopic cholecystectomy now unfolding in New York State and elsewhere.”1Grimes DA Laparoscopic surgery: experiment or expedient? [Letter].AM J OBSTET GYNECOL. 1993; 168: 1333-1334Abstract Full Text PDF PubMed Google Scholar What is clear is that Chandler's concerns have not inhibited him from adopting laparoscopic techniques himself or from advertising this fact, for I note that his letterhead lists “Laparoscopic Surgery” as one of the services he offers. The case for using randomized trials to study laparoscopic surgery is invalid for many reasons as I explained in a recent paper,2Kadar N. The operative laparoscopy debate: technology assessment or statistical Jezebel? Biomed Pharmacother [In press].Google Scholar a copy of which has been sent to Chandler. Suffice it to say that I was disappointed that Grimes1 chose to attack the veracity of my comments on the pretext that I failed to reference the statement “most randomized trials yield negative results.” Am I to believe that he doubts the truth of this statement when an entirely new class of statistical techniques has been developed specifically to deal with the problem (meta-analysis)? I am sure he is aware that Sacks et al.3Sacks HS Chalmers TC Smith H Sensitivity and specificity of clinical trials.Arch Intern. 1983; 143: 753-755Crossref PubMed Scopus (77) Google Scholar found the sensitivity of randomized trials to range between 0% and 27% (mean 12%) and that many eminent surgeons agree with me that because important differences exist between new drugs and new operations different methods must be used to study them.4Lowe JW Drugs and operations: some important differences.JAMA. 1975; 232: 37-38Crossref PubMed Scopus (38) Google Scholar, 5Bonchek LI Are randomized clinical trials appropriate for evaluating new operations?.N Engl J Med. 1979; 301: 44-45Crossref PubMed Scopus (70) Google Scholar, 6van der Linden W Pitfalls in randomized surgical trials.Surgery. 1980; 87: 258-262PubMed Google Scholar I congratulate Chandler on his appointment as president of the medical staff, but secular success is not an acceptable substitute for scientific evidence in justifying personal opinions. In the absence of data I remain skeptical that his rosy statements about abdominal hysterectomy reflect the true situation at Princeton, unless, of course, difficult hysterectomies are sent elsewhere. I would agree that the therapeutic ratio for laparoscopic hysterectomy is narrower than for laparoscopic cholecystectomy, because abdominal hysterectomy is less morbid than open cholecystectomy, but hysterectomy is the more difficult operation to perform laparoscopically and requires greater endoscopic skills. This, however, simply means that the laparoscopic approach must be deployed on difficult cases and not on those amenable to conventional vaginal hysterectomy. If Chandler had seen the laparoscopic hysterectomy and lymphadenectomy I performed this week (June 2, 1993) on a 300-pound woman for endometrial carcinoma (a tedious affair to be sure) and witnessed her dramatic recovery, he might better understand why gynecologists at more progressive hospitals eagerly put themselves out to learn the operation. We recently reported that in 22 women weighing >200 pounds (mean 239 pounds) who had a laparoscopic hysterectomy there were no failures, no significant surgical injuries, and no febrile or hemorrhagic complications, and the average hospital stay was 3.2 days.7Kadar N Pelosi MA Laparoscopically assisted hysterectomy in women weighing 200 pounds or more [Abstract].in: Proceedings of the 1993 international meeting of the Society for Minimally Invasive Therapy, Orlando, Florida, November 5-7, 1993. Society for Minimally Invasive Therapy, Orlando1993Google Scholar Nine women had concurrent lymphadenectomy, bladder suspension, or extensive lysis of adhesions. I believe these results are superior to what can be achieved with an open approach, and I don't believe one needs a randomized trial to prove it. The success of inchoate procedures increases with experience, and any drawbacks are frequently offset by benefits. The complication rate of the Kock ileal pouch, for example, has been reduced threefold to fourfold over the last 10 years, yet the rate remains higher than for a standard ileal conduit. Nonetheless, many patients accept the added risks in exchange for a chance to avoid a urostomy bag. This is the situation with many laparoscopic operations." @default.
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• W2079236105 title "Reply to: Laparoscopic pelvic surgery: Better? Safer?" @default.
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