OBJECTIVE: Concerns exist about the risk of endometrial cancer cells spreading into the peritoneal cavity after fluid minihysteroscopy. The aim of our study was to evaluate the 5-year incidence of pelvic recurrences in women affected by early-stage endometrial carcinoma (stage IA or IB) who did or did not undergo preoperative hysteroscopy with low pressure (<70 mm Hg) saline uterine distention. METHODS: A total of 140 women were randomized into two groups of 70 women who underwent or did not undergo diagnostic fluid minihysteroscopy before surgical staging. Women were followed up every 6 months for at least 5 years. Diagnosis of pelvic recurrence was based on a positive result at clinical examination and/or at vaginal cytology and/or at magnetic resonance imaging/positron emission tomography scan. Univariate analysis of disease-free survival was performed with the Kaplan-Meier method and survival curves were compared using the long-rank test. RESULTS: No difference in peritoneal cytology was observed between the two groups (5.7% and 8.5% of cases in the hysteroscopy and control group, respectively). After a mean duration of follow-up of 62 months, 2 (2.85%) pelvic recurrences in the hysteroscopy group and 3 (4.28%) in the control group were found. No significant difference was found between the two groups when the recurrence rate was compared. Overall survival rates and disease-free survival projected by Kaplan-Meier curves were not significantly different for the two groups. CONCLUSIONS: Preoperative low-pressure fluid minihysteroscopy does not increase the risk of intraperitoneal transport of endometrial carcinoma cells during the examination or the risk of pelvic recurrence at the 5-year follow-up. It does not seem to modify the recurrence rate, disease-free survival, and overall survival, although multicenter randomized trials and long-term follow-up are required to evaluate the overall oncologic outcomes of this procedure.
RCT Entities:
OBJECTIVE: Concerns exist about the risk of endometrial cancer cells spreading into the peritoneal cavity after fluid minihysteroscopy. The aim of our study was to evaluate the 5-year incidence of pelvic recurrences in women affected by early-stage endometrial carcinoma (stage IA or IB) who did or did not undergo preoperative hysteroscopy with low pressure (<70 mm Hg) saline uterine distention. METHODS: A total of 140 women were randomized into two groups of 70 women who underwent or did not undergo diagnostic fluid minihysteroscopy before surgical staging. Women were followed up every 6 months for at least 5 years. Diagnosis of pelvic recurrence was based on a positive result at clinical examination and/or at vaginal cytology and/or at magnetic resonance imaging/positron emission tomography scan. Univariate analysis of disease-free survival was performed with the Kaplan-Meier method and survival curves were compared using the long-rank test. RESULTS: No difference in peritoneal cytology was observed between the two groups (5.7% and 8.5% of cases in the hysteroscopy and control group, respectively). After a mean duration of follow-up of 62 months, 2 (2.85%) pelvic recurrences in the hysteroscopy group and 3 (4.28%) in the control group were found. No significant difference was found between the two groups when the recurrence rate was compared. Overall survival rates and disease-free survival projected by Kaplan-Meier curves were not significantly different for the two groups. CONCLUSIONS: Preoperative low-pressure fluid minihysteroscopy does not increase the risk of intraperitoneal transport of endometrial carcinoma cells during the examination or the risk of pelvic recurrence at the 5-year follow-up. It does not seem to modify the recurrence rate, disease-free survival, and overall survival, although multicenter randomized trials and long-term follow-up are required to evaluate the overall oncologic outcomes of this procedure.
Authors: Clemens Tempfer; Georg Froese; Bernd Buerkle; Stephan Polterauer; Christoph Grimm; Nicole Concin; Gerda Hofstetter; Monika Weigert; Martin K Oehler Journal: Exp Ther Med Date: 2011-06-30 Impact factor: 2.447