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.


RESULTS
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).


CONCLUSIONS
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.


BACKGROUND
The Dutch Organization for Health Research and Development (ZonMw), programme efficacy.
Mourits
Marian J E
MJ
Department of Gynaecology, University Medical Center Groningen, University of Groningen, The Netherlands. m.j.e.mourits@og.umcg.nl
Bijen
Claudia B
CB
Arts
Henriëtte J
HJ
ter Brugge
Henk G
HG
van der Sijde
Rob
R
Paulsen
Lasse
L
Wijma
Jacobus
J
Bongers
Marlies Y
MY
Post
Wendy J
WJ
van der Zee
Ate G
AG
de Bock
Geertruida H
GH
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018269:Carcinoma, Endometrioid / Q000473:pathology / Q000601:surgery*; D004714:Endometrial Hyperplasia / Q000473:pathology / Q000601:surgery*; D016889:Endometrial Neoplasms / Q000473:pathology / Q000601:surgery*; D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000009:adverse effects / Q000379:methods*; D057194:Intention to Treat Analysis; D007431:Intraoperative Complications; D010535:Laparoscopy / Q000009:adverse effects*; D007813:Laparotomy / Q000009:adverse effects*; D007902:Length of Stay; D008875:Middle Aged; D009426:Netherlands; D010052:Ovariectomy / Q000009:adverse effects / Q000379:methods*; D011183:Postoperative Complications; D011788:Quality of Life; D012449:Safety