1. Clinical Decision on Harm

2. Clinical scenario or question Will laparoscopic hysterectomy increase post operative complications for our obese patient with endometrial cancer?

3. Search Pub med keywords – Endometrial cancer – Obese – Laparoscopy – Complications

6. Hysterectomy for Obese Women with Endometrial Cancer: Laparoscopy or Laparotomy? Gamal H. Eltabbakh, M.D., Mousa I. Shamonki, M.D., Joanne M. Moody, R.N., and Lynda Lee Garafano, R.N. Division of Gynecologic Oncology, University of Vermont College of Medicine, Burlington, Vermont 05401 Received January 6, 2000

7. Patients Population – 80 obese women who presented with clinical stage I endometrial cancer Intervention – Laparoscopy Outcome – Post operative complications Methodology – Prospective study

8. Relevance Is the objective of the article on harm similar to your clinical dilemma? – Yes, the objective of this journal answers our clinical question. – The parameters (population, intervention and outcome) used in the journal is also similar with our patient

9. Validity Were there clearly identified comparison groups? – Yes – The journal states that obese women who underwent LAVH (experimental group) were compared against those who underwent TAH (control group)

10. Validity Did investigators assemble clearly defined groups of patients similar in all important ways other than exposure? – Yes, all patients were similar in the beginning of the study

11. Validity Were the exposures and outcomes measured in the same way in the groups compared? – Yes. The paper mentions that: Preoperative patient data were extracted in terms of the same demographic category Both groups were subjected to surgical intervention The same postoperative results and events were noted for both groups

12. Validity Was follow-up sufficiently long and complete? – Yes. All patients were followed till the end and accounted for – Group A: all patients were accounted for because they were taken from patient charts – Group B: all patient data were accounted for because they followed up the patient for 30 days postoperatively. Most of the outcomes measured by the author would have been apparent in that 30 day period

13. Validity Is the temporal relationship between the exposure and outcome correct and dose response gradient present? Yes, the outcome was assessed directly after the interventions which are defined as TAH and LAVH Dose response gradient is present.

14. Validity Overall, is the study valid? – Yes, since all validity guides were satisfied satisfactorily, study is valid. – All the outcome measured follow intervention which establishes the temporal aspect

15. Study Design TAH GROUP 40 historical TAH patients taken from charts 40 patients analyzed through charts LAVH GROUP 42 patients offered LAVH 2 patients removed because of inclusion criteria 40 patients LAVH Post operative events and details were analyzed

16. Results The study found significance in: – Drop in Hct – Operative time – Number of pelvic nodes sampled – Amount of pain medication – Length of hospital stay

17. Results

18. Results related to our outcome

19. Event rate

20. Catmaker Results What is the magnitude of the association between exposure and outcome? – RR of having 0.75 complications for laparoscopy compared to laparotomy – Need to expose 40 people before there is a decrease of 1 complication

21. Significance of Chi squared Chi square of 0.63 is between P value of 0.5- 0.3 Using the net. P value is – Probability (One-Tailed): 0.427355 Like author said, difference is NOT SIGNIFICANT

22. Results What was the magnitude of association between exposure and outcome? Was the estimate of the risk precise? – RR of having 0.75 complications for laparoscopy compared to laparotomy  REDUCES HARM – 95% CI shows high and low limits below 1  REDUCTION IN HARM

23. Can the results help me in caring for my patients? Are the study patients similar to my own? – Yes Age Height BMI Postmenopause Previous laparotomy Medical problems – Somewhat (within range) Weight Parity

24. Can the results help me in caring for my patients? Should I attempt to stop the exposure? – How large and precise is the risk of harm? It may cause a little harm since exposure is beneficial. – What are the consequences if I withdraw exposure? It will cause harm to patient. – Do I have any alternatives? Control operation which is laparotomy UNDERSTAND THAT POSTOPERATIVE COMPLICATIONS ARE NOT SIGNIFICANT!

25. Resolution of the problem in the scenario Laparoscopy is superior in decreasing operative time, pain medication amount and length of hospital stay. With regards to our clinical question, it slightly reduces the amount of postoperative complications BUT is non significant. Applicability wise laparotomy is an alternative choice if patient does not have bleeding problems and is financially constraint.