2 The procedure
2.1.1 Cervical cancer is the second most common cancer in women under 35 years in the UK. The most common symptoms are abnormal vaginal bleeding or discharge, and discomfort during intercourse.
2.1.2 The International Federation of Gynecology and Obstetrics (FIGO) system is used to stage cervical cancer from I to IV. Early stage cervical cancer includes stages I (cancer confined to the cervix) to IIA (tumour invades the cervix with endocervical glandular involvement only).
2.1.3 Early stage cervical cancer is usually treated by radical hysterectomy. Radiotherapy may be used, with or without surgery, and is usually combined with chemotherapy. More advanced cervical cancer is generally treated with radiotherapy and chemotherapy.
2.2.1 Laparoscopic radical hysterectomy for early stage cervical cancer is carried out with the patient under general anaesthesia. Several small incisions provide access for the laparoscope and surgical instruments. The abdomen is insufflated with carbon dioxide. The uterus, supporting ligaments and the upper vagina are removed along with pelvic lymph nodes and sometimes the para-aortic lymph nodes.
Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
2.3.1 A non-randomised comparative study of 102 patients with stage IA–IIB cervical cancer reported 3-year overall survival of 82% for patients treated by both abdominal and laparoscopic radical hysterectomy.
2.3.2 A non-randomised comparative study of 127 patients with stage IA–IB cervical cancer reported a disease-free survival rate of 92% for laparoscopic radical hysterectomy and 94% for abdominal radical hysterectomy at median follow-up of 53 and 72 months respectively (p = 0.29) (absolute figures not stated).
2.3.3 A case series of 78 patients with stage IA–IB cervical cancer reported an estimated 5-year overall survival rate of 94% (absolute figures not stated).
2.3.4 A non-randomised comparative study of 125 patients with stage IB–IIA cervical cancer reported a recurrence rate of 14% for laparoscopic radical hysterectomy and 12% for abdominal radical hysterectomy, at a median follow-up of 26 months (reported as 'not significant') (absolute figures not stated).
2.3.5 The non-randomised comparative study of 127 patients reported that significantly fewer lymph nodes were removed in patients treated by laparoscopic radical hysterectomy than abdominal radical hysterectomy (mean 23.5 and 25.2 respectively) (p < 0.01).
2.3.6 The Specialist Advisers listed key efficacy outcomes as completing the procedure without conversion to open surgery, number of lymph nodes removed, recovery time and length of hospital stay, rate of cancer recurrence, and 5-year survival.
2.4.1 Rates of intraoperative bladder injury during laparoscopic radical hysterectomy and abdominal radical hysterectomy ranged from 1% (3/248 and 1/101) to 10% (5/50), and from 0% (0/35) to 4% (2/48) respectively across the studies.
2.4.2 A case report described complete bladder gangrene 3 weeks after laparoscopic radical hysterectomy in 1 patient. The patient underwent a total cystectomy and cutaneous ureterostomy and recovered fully with no cancer recurrence at 33-month follow-up.
2.4.3 Intraoperative ureteric injury rates ranged from 0% (0/90) to 4% (2/50) during laparoscopic radical hysterectomy (2 were treated laparoscopically) and from 0% (0/48) to 6% (2/35) during abdominal radical hysterectomy (no further details given).
2.4.4 Intraoperative bowel injury was reported in 2% (1/46), 1% (2/248; laparoscopically sutured) and 1% (3/295; 2 sutured vaginally and 1 conversion to open surgery) of patients in the non-randomised comparative study of 102, and case series of 248 and 295 patients respectively.
2.4.5 The non-randomised comparative studies of 98 and 125 patients reported, respectively, ureteric fistula in 2% (1/50; from ischaemic necrosis requiring further open surgery at 14-day follow-up) and 1% (1/90; postoperative, managed conservatively) of patients treated by laparoscopic radical hysterectomy. No ureteric fistulae were reported in patients treated by abdominal radical hysterectomy. Postoperative ureteric fistula was reported in 5% (5/101) of patients in the case series of 101 patients (1 required ureteral reimplantation, 4 treated with stents; timing of events not stated).
2.4.6 Postoperative vesicovaginal fistula was reported in 1% (1/90) and 2% (1/50) of patients treated by laparoscopic radical hysterectomy compared with no patients treated by abdominal radical hysterectomy in the non-randomised comparative studies of 125 and 98 patients (not otherwise described).
2.4.7 Splenic rupture 5 days after laparoscopic radical hysterectomy was reported in a case report; the patient was treated by a splenectomy.
2.4.8 The Specialist Advisers considered theoretical adverse events to include inadequate lymph node sampling and excision of the primary tumour.