Efficacy of different surgical approaches on survival outcomes in patients with early-stage cervical cancer: protocol for a multicentre longitudinal study in China

Abstract

Introduction: Recent studies have revealed that the oncological survival outcomes of minimally invasive radical hysterectomy (MIRH) are inferior to those of abdominal radical hysterectomy (ARH) in early-stage cervical cancer, but the potential reasons are unclear.

Methods and analysis: Each expert from 28 study centres participating in a previously reported randomised controlled trial (NCT03739944) will provide successive eligible records of at least 100 patients who accepted radical hysterectomy for early-stage cervical cancer between 1 January 2009 and 31 December 2015. Inclusion criteria consist of a definite pathological evaluation of stages IA1 (with positive lymphovascular space invasion), IA2 and IB1 according to the International Federation of Gynecology and Obstetrics 2009 staging system and a histological subtype of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma. The primary endpoint is 5-year disease-free survival between the MIRH and ARH groups. The secondary endpoints include the MIRH learning curves of participating surgeons, 5-year overall survival between the MIRH and ARH groups, survival outcomes according to surgical chronology, surgical outcomes and sites of recurrence and potential risk factors that affect survival outcomes. A subgroup analysis in patients with tumour diameter less than 2 cm will follow the similar flow diagram.

Ethics and dissemination: This study has been approved by the Institutional Review Board of Peking Union Medical College Hospital (registration no. JS-1711), and is also filed on record by all other 27 centres. The results will be disseminated through community events and peer-reviewed journals.

Trial registration number: NCT03738969.

Keywords: adult surgery; gynaecological oncology; minimally invasive surgery.

Figure 1

Flow diagram of the study. ARH, abdominal RH; DFS, disease-free survival. MIRH, minimally invasive RH; OS, overall survival. RH, radical hysterectomy.

Figure 2

Judgement of learning curves of the study. Patients with MIRH will be divided into subgroups of first 30 cases, second 30 cases and and others. The 5-year DFS of these subgroup of patients with MIRH will be compared with the DFS of patients with ARH to explore the potential differences. The 5-year DFS of subgroup of patients with MIRH will also be compared with the DFS of first 30 patients with MIRH to find out the potential plateau of DFS. ARH, abdominal radical hysterectomy. DFS, disease-free survival. MIRH, minimally invasive radical hysterectomy.