3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 26 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial (reported in 3 publications), 13 non-randomised comparative studies, 1 cohort study, 2 systematic reviews and 7 case reports. Data from the National Cancer Registration and Analysis Service were also reviewed by the committee. The evidence is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: overall survival, disease-free survival, tumour recurrence, quality of life, and need for postoperative chemotherapy or radiotherapy.
3.3 The professional experts and the committee considered the key safety outcomes to be: mortality, unintentional damage to adjacent structures such as the bowel or ureter, and tumour seeding.
3.4 A submission from a patient organisation was discussed by the committee.
3.5 This guidance does not cover simple laparoscopic hysterectomy for stage 1a1 disease.
3.6 The committee was advised that there could be seeding of malignant cells from the cervix during the procedure related to using a manipulator to position the cervix, and that this needs further investigation.
3.7 The committee felt that research into variations in the technique designed to reduce the risk of tumour seeding or other potential causes of long-term tumour recurrence may be appropriate.
3.8 The committee was advised that there may be some patients for whom the risks of an open procedure are such that, after careful consideration by a multidisciplinary team and with appropriate patient consent, minimally invasive radical hysterectomy could be offered.