OBJECTIVE: To evaluate perioperative surgical outcomes and resection size for laparoscopically assisted radical vaginal hysterectomy (LARVH) compared with radical abdominal hysterectomy (RAH). DESIGN: A prospective randomised phase II trial. POPULATION: Early stage IB cervical cancer requiring radical surgical treatment. SETTING: Northern Gynaecological Oncology Centre, Gateshead, UK. METHODS:Fifteen women were randomised to LARVH and to RAH. MAIN OUTCOME MEASURES: Outcomes included requirement in days for bladder catheterisation after surgery, operating time, blood loss, hospital stay, opiate pain relief, complication rate, time to normal activities and resection size of major ligaments and vaginal cuff. Results Statistically significant differences were found between LARVH and RAH, respectively: median duration of bladder catheterisation, 4 days versus 21 days (P = 0.003); median operating time, 180 minutes versus 138 minutes (P = 0.05); median blood loss, 400 ml versus 1000 ml (P = 0.05), median hospital stay, 5 days versus 7 days (P = 0.04) and median opiate requirement in the first 36 hours postoperatively, 30 mg versus 53 mg (P = 0.004). The mean resected lengths for LARVH versus RAH, respectively, were: mean resected vaginal cuff, 1.26 cm versus 2.16 cm (P = 0.014); mean resected cardinal ligament length, 1.30 cm versus 2.79 cm (P = 0.013) and mean resected uterosacral ligament length, 1.47 cm versus 4.68 cm (P = 0.034). CONCLUSIONS: This study confirms the short-term surgical benefits of LARVH. In addition, LARVH has been shown to be a less radical procedure than RAH, supporting the need for strict patient selection and to restrict the procedure to small tumours.
RCT Entities:
OBJECTIVE: To evaluate perioperative surgical outcomes and resection size for laparoscopically assisted radical vaginal hysterectomy (LARVH) compared with radical abdominal hysterectomy (RAH). DESIGN: A prospective randomised phase II trial. POPULATION: Early stage IB cervical cancer requiring radical surgical treatment. SETTING: Northern Gynaecological Oncology Centre, Gateshead, UK. METHODS: Fifteen women were randomised to LARVH and to RAH. MAIN OUTCOME MEASURES: Outcomes included requirement in days for bladder catheterisation after surgery, operating time, blood loss, hospital stay, opiate pain relief, complication rate, time to normal activities and resection size of major ligaments and vaginal cuff. Results Statistically significant differences were found between LARVH and RAH, respectively: median duration of bladder catheterisation, 4 days versus 21 days (P = 0.003); median operating time, 180 minutes versus 138 minutes (P = 0.05); median blood loss, 400 ml versus 1000 ml (P = 0.05), median hospital stay, 5 days versus 7 days (P = 0.04) and median opiate requirement in the first 36 hours postoperatively, 30 mg versus 53 mg (P = 0.004). The mean resected lengths for LARVH versus RAH, respectively, were: mean resected vaginal cuff, 1.26 cm versus 2.16 cm (P = 0.014); mean resected cardinal ligament length, 1.30 cm versus 2.79 cm (P = 0.013) and mean resected uterosacral ligament length, 1.47 cm versus 4.68 cm (P = 0.034). CONCLUSIONS: This study confirms the short-term surgical benefits of LARVH. In addition, LARVH has been shown to be a less radical procedure than RAH, supporting the need for strict patient selection and to restrict the procedure to small tumours.