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Safety of laparoscopy versus laparotomy in early-stage endometrial cancer: A randomised trial
The Lancet Oncology - Online First, 07/20/2010
Clinical Article
Mourits MJE et al. – This study investigated the complication rate of TLH versus TAH in women with early-stage endometrial cancer.
Methods- Randomised trial was done in 21 hospitals in the Netherlands, and 26 gynecologists 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 6 and 3 participants, with stratification by trial center
- Primary outcome was major complication rate, assessed by an independent panel
- Data were analysed by a modified intention-to-treat analysis, since 2 patients in both groups were excluded from the main analysis
- 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)
- 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 (5 of 185 [2·7%]) and TAH (4 of 94 [4·3%]; p=0·49)
- 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)
