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.