Laparoscopy versus laparotomy in endometrial cancer: first analysis of survival of a randomized prospective study.

STUDY OBJECTIVE

Laparoscopy has been proved to be safe and reliable in staging of patients with endometrial cancer. It has definite advantages over laparotomy, but a comparable survival outcome is still to be verified in prospective randomized trials.

DESIGN

Prospective, randomized clinical trial.

SETTING

Department of Gynecology, Friedrich Schiller University, Jena, Germany.

PATIENTS

One hundred twenty-two women with uterine cancer.

INTERVENTIONS

Laparotomy and laparoscopy.

MEASUREMENTS AND MAIN RESULTS

Sixty-three patients were allocated to the laparoscopy arm, and 59 were allocated to the laparotomy arm. Median follow-up for all patients was 44 months (range 5-96 months). Eight patients (12.6%) in the laparoscopy group had a recurrence versus five patients (8.5%) in the laparotomy group (p = .65). At median follow-up, disease-free survival (DFS) and overall survival (OS) in the laparoscopy group and laparotomy group were 87.4% versus 91.6% and 82.7% versus 86.5%, respectively. Cause-specific survival (CSS) was 90.5% in the laparoscopy group versus 94.9% in the laparotomy group. In patients with International Federation of Gynecology and Obstetrics stage I, DFS was 91.2% in the laparoscopy group versus 93.8% in the laparotomy group, OS was 86.5% versus 89.7%, and CSS was 93.4% versus 95.9%.

CONCLUSION

Laparoscopic vaginal treatment of patients with endometrial cancer provides a survival outcome comparable with laparotomy. If these data are confirmed, laparoscopic procedures should be included in routine therapy for patients with endometrial cancer.