Cost effectiveness of laparoscopy versus laparotomy in early stage endometrial cancer: a randomised trial.

OBJECTIVE: To determine the cost effectiveness of total laparoscopic hysterectomy (TLH) versus total abdominal hysterectomy (TAH) in early stage endometrial cancer alongside a multicenter randomised controlled trial (RCT). METHODS: An economic analysis was conducted in 279 patients (TLH n=185; TAH n=94) with early stage endometrial cancer from a societal perspective, including all relevant costs over a three month time horizon. Health outcomes were expressed in terms of major complication-free rate and in terms of utility based on women's response to the EQ-5D. Comparisons of costs per major complication-free patient gained and costs with utility gain and costs were made, using incremental cost effectiveness ratios. RESULTS: The mean major complication-free rate and median utility scores were comparable between TLH and TAH at three months. TLH is more costly intraoperatively (Δ$1.129) and less costly postoperatively in-hospital (Δ$-1.350) compared to TAH. Incremental costs per major complication-free patient were $-52. Higher cost ($249) were generated while no gains in utility (-0.02) were observed for TLH compared to TAH. Analysing utility at six weeks, incremental costs per additional point on the EQ-5D scale were $1.617. CONCLUSION: TLH is cost effective compared to TAH, based on major complication-free rate as measure of effect. Along with future cost saving strategies in laparoscopy, TLH is assumed to be cost effective for both effect measures. Therefore and due to comparable safety, TLH should be recommended as a standard-of-care surgical procedure in early endometrial cancer.

Safety of laparoscopy versus laparotomy in early-stage endometrial cancer: a randomised trial.

BACKGROUND: The standard surgery for early-stage endometrial cancer is total abdominal hysterectomy (TAH) and bilateral salpingo-oophorectomy, which is associated with substantial morbidity. Total laparoscopic hysterectomy (TLH) and bilateral salpingo-oophorectomy is less invasive and is assumed to be associated with lower morbidity, particularly in obese women. This study investigated the complication rate of TLH versus TAH in women with early-stage endometrial cancer. METHODS: This randomised trial was done in 21 hospitals in The Netherlands, and 26 gynaecologists with proven sufficient skills in TLH participated. 283 patients with stage I endometrioid adenocarcinoma or complex atypical hyperplasia were randomly allocated (2:1) to the intervention group (TLH, n=187) or control group (TAH, n=96). Randomisation by sequential number generation was done centrally in alternate blocks of six and three participants, with stratification by trial centre. After assignment, the study coordinators, patients, gynaecologists, and members of the panel were not masked to intervention. The primary outcome was major complication rate, assessed by an independent panel. Data were analysed by a modified intention-to-treat analysis, since two patients in both groups were excluded from the main analysis. This trial is registered with the Dutch trial registry, number NTR821. FINDINGS: The proportion of major complications was 14.6% (27 of 185) in the TLH group versus 14.9% (14 of 94) in the TAH group, with a difference of -0.3% (95% CI -9.1 to 8.5; p=0.95). The proportion of patients with an intraoperative major complication (nine of 279 [3.2%]) was lower than the proportion with a postoperative major complication (32 of 279 [11.5%]) and did not differ between TLH (five of 185 [2.7%]) and TAH (four of 94 [4.3%]; p=0.49). The proportion of patients with a minor complication was 13.0% (24 of 185) in the TLH group and 11.7% (11 of 94) in the TAH group (p=0.76). Conversion to laparotomy occurred in 10.8% (20 of 185) of the laparoscopic procedures. TLH was associated with significantly less blood loss (p<0.0001), less use of pain medication (p<0.0001), a shorter hospital stay (p<0.0001), and a faster recovery (p=0.002), but the procedure took longer than TAH (p<0.0001). INTERPRETATION: Our results showed no evidence of a benefit for TLH over TAH in terms of major complications, but TLH (done by skilled surgeons) was beneficial in terms of a shorter hospital stay, less pain, and quicker resumption of daily activities. FUNDING: The Dutch Organization for Health Research and Development (ZonMw), programme efficacy.