Clinical Decision on Harm. Clinical scenario or question Will laparoscopic hysterectomy increase...
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Transcript of Clinical Decision on Harm. Clinical scenario or question Will laparoscopic hysterectomy increase...
Clinical Decision on Harm
Clinical scenario or question
• Will laparoscopic hysterectomy increase post operative complications for our obese patient with endometrial cancer?
Search
• Pub med keywords– Endometrial cancer– Obese– Laparoscopy– Complications
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
Patients
• Population– 80 obese women who presented with clinical
stage I endometrial cancer• Intervention– Laparoscopy
• Outcome– Post operative complications
• Methodology– Prospective study
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
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)
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
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
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
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.
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
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
Results
• The study found significance in:– Drop in Hct– Operative time– Number of pelvic nodes
sampled– Amount of pain
medication– Length of hospital stay
Results
Results related to our outcome
Event rate
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
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
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
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
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!
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.