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 of Obstetrics 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, higher scores indicating better quality of life DomainsNumber of Items Physical Functioning10 Physical Role Functioning4 Body Pain2 General Health Perception5 Vitality4 Social Function2 Emotional Role Function3 Mental Health5

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 CharacteristicPopulation of the study Patient Age62.1 ± BMI29.9 ± 7.533

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 paragraph 6

SF-36