Clinical Questions

• What is the superior surgical approach for postmenopausal women with early stage endometrial cancer in terms of patient quality of life?

• What is the superior surgical approach for postmenopausal women with early stage endometrial cancer in terms of intraoperative complications?

• Population: Postmenopausal women with early endometrial carcinoma

• Intervention: Surgery• Outcome: Quality of life and intraoperative

complications• Methodology: Randomized Control Trial

A prospective randomized comparison between laparoscopic and laparotomic approaches in

women with early stage endometrial cancer: A focus on the quality of life

Fulvio Zullo, MD, Stefano Palomba, MD,* Tiziana Russo, MD, Angela Falbo, MD, Marilena Costantino, MD,a Achille Tolino, MD, Errico Zupi, MD, Piersandro Tagliaferri, MD,d Salvatore Venuta, MDd

Departments of Obstetrics and Gynecologya and Oncology,d University ‘‘Magna Graecia’’ of Catanzaro, Catanzaro,Italy; Department of Obstetrics and Gynecology, University ‘‘Federico II’’ of Naples,b Naples, Italy; Department ofObstetrics and Gynecology, University ‘‘Tor Vergata’’ of Rome,c Rome, Italy

Critical Appraisal

Relevance• Compare two therapeutic interventions for early stage

endometrial carcinoma based on quality of life using Short-Form Healthy Survey (SF-36 scoring system)– well validated generic measure of QoL score range, 0-100

• higher scores indicating better quality of life

Domains Number of Items

Physical Functioning 10

Physical Role Functioning 4

Body Pain 2

General Health Perception 5

Vitality 4

Social Function 2

Emotional Role Function 3

Mental Health 5

SF – 36 in Clinical Epidemiology

• The IQOLA (International Quality of Life Assessment) Project was established in 1991 to translate and validate the SF-36 Health Survey and other measures of patient-reported outcomes for international use.

• Papers describing IQOLA methods and their application to the SF-36 were published in 1998 in a 320-page issue of the Journal of Clinical Epidemiology that contained work from 15 countries.

•

SF – 36 in Clinical Epidemiology

• The SF-36 is a generic measure, as opposed to one that targets a specific age, disease, or treatment group.

• Thus, it has been useful in assessing • the health of general and specific populations,• comparing the relative burden of diseases• differentiating the health benefits produced by a wide

range of treatments, and screening individual patients. • The widespread applicability of the SF-36 is apparent in the

more than 5,000 publications that have used this measure.

Relevance• Clinical case question applicable• Population: 138 women with early stage endometrial

cancer, i.e. stage I according to FIGO classification• Intervention: laparoscopic and laparotomic

hysterectomy• Outcomes:

• In early stage endometrial cancer, the laparoscopic approach provides significant benefits compared with laparotomy in terms of QoL.

• Intra-operative complications incidence resulted similar in both treatment groups (7.5% vs 10.5%)

VALIDITY

Validity

• Randomized control Trial– 84 women with clinical stage I endometrial cancer

were enrolled in a prospective randomized controlled trial design and treated with laparoscopic or laparotomic approach.

figure 1 p.1346

Were all the patients properly accounted for and attributed at its conclusion?

• Yes. Follow-up was complete– After the first 6-month follow-up, there was only 1 case

(laparoscopic group) of recurrence and no deaths occurred in either group.

– The control and treatment group are analyzed from beginning to end

– Exclusion of non compliant patients:• 4 missed the first follow-up visit in laparotomy• 2 missed the first follow-up visit in laparoscopy

figure 1 p.1346

Were patients, their clinicians and study personnel blind to treatment?

• Yes. Single-Blind– All eligible patients were randomly assigned in

singleblocks into a single-blind controlled study design with the use of a computer-generated randomization list. The subjects were assigned to 1 of the 2 surgical treatment groups

p.1345 paragraph 7

Were the groups similar at the start of the trial?

• Yes• Initial work up:

– Gynecologic and rectal exam

– Pap smear– UTZ and hysteroscopic

assessment with endometrial biopsy

– Liver UTZ– CXR and CT

• Assessment of:– Age– Parity– BMI– Menopausal status– Socio-economic and

work status with QoL– Previous laparotomies– Associated medical

conditions

Were the groups similar at the start of the trial?

• Control group– Matched with

demographic characteristics with patients

– Same exclusion criteria

• Exclusion criteria: – Other premalignancies

or malignancies– Major medical

conditions– Psychiatric disorders– current or past history of

acute or chronic physical illness

– premenstrual syndrome– current or past use of

drugs influencing cognition, vigilance and mood

Aside from the experimental interventions, were the groups

treated equally• Yes• Both groups were treated equally

Is the overall study valid?

• Yes• All of the above criteria were met

RESULTS

What are the results? QUALITY OF LIFE

Figure 2 Total SF-36 score (mean ± SD) in laparoscopic and laparotomic group, and in controls. *P < .05 vs controls; P< .05 vs baseline; P <.05 vs laparoscopic group; P< .05 vs first month follow-up.

What are the results?INTRAOPERATIVE COMPLICATIONS

Relative Risk

• RC =event in control/ # of px in control = 4/38 = .105 = 10.5 %

• RT = event in treatment/number of px in treatment = 3/40 = .075

= 7.5%• RR = RT/RC = .075/.105 = .714

How precise was the treatment effect?

• All p values are <.05• The study is precise

Can the results be applied to patient?

• Yes• All women with clinical stage I endometrial

cancer

Characteristic Population of the study

Patient

Age 62.1 ± 14.5 58

BMI 29.9 ± 7.5 33

What are clinical outcomes considered?

• Quality of life (Standardized by the SF-36 form)– Physical functioning– Physical role functioning– Bodily pain– General health perceptions– Vitality– Social functioning– Emotional role functioning– Mental health

• Intraoperative complications

Are the likely benefits worth the potential harm and cost?

• Yes– Low intraoperative and postoperative complications

rates observed in the laparoscopic group, highlights the safety of this surgical approach

– The incidence of intraoperative complications resulted similar in both treatment groups (7.5 vs 10.5%), whereas a lower rate of postoperative complications (27.5% vs 47.4%) was observed after laparoscopic surgery

p.1349 paragraph 9

Are the likely benefits worth the potential harm and cost?

• No significant difference in intraoperative complications was observed between groups, whereas postoperative complications were significantly (P<.05) less common in the laparoscopic group than in the laparotomic group (Table III)

P. 1348 paragraph 6

SF-36