A phase 3, international, randomized trial compared the safety and efficacy of simple hysterectomy with radical hysterectomy in treating low-risk early-stage cervical cancer. The study involved 700 participants, predominantly with stage IB1 disease, who were randomized to receive either simple or radical hysterectomy. The primary outcome measured was cancer recurrence in the pelvic area within 3 years.
Simple hysterectomy involves the removal of the uterus and cervix without adjacent parametria, whereas radical hysterectomy includes the removal of the uterus, cervix, one-third of parametria, 2 cm of the uterosacral ligaments, and the upper 1 to 2 cm of the vagina. The study found that the incidence of pelvic recurrence was similar between the two groups, with 2.52% in the simple hysterectomy group and 2.17% in the radical hysterectomy group, indicating a minimal difference of 0.35%.
Moreover, simple hysterectomy was associated with reduced odds of abdominal surgery and a higher likelihood of laparoscopic surgery compared to radical hysterectomy. The study also noted that simple hysterectomy led to fewer urologic complications, such as bladder and ureteral injuries, compared to radical hysterectomy.
These findings suggest that simple hysterectomy is a viable and potentially safer alternative to radical hysterectomy for low-risk early-stage cervical cancer patients, offering similar efficacy in preventing pelvic recurrence while reducing the risk of surgical complications.
