PMID- 32819996
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210514
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 10
IP  - 8
DP  - 2020 Aug 20
TI  - Efficacy of different surgical approaches on survival outcomes in patients with 
      early-stage cervical cancer: protocol for a multicentre longitudinal study in 
      China.
PG  - e038020
LID - 10.1136/bmjopen-2020-038020 [doi]
LID - e038020
AB  - 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.
CI  - (c) Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Chao, Xiaopei
AU  - Chao X
AD  - Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China.
FAU - Wu, Ming
AU  - Wu M
AD  - Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China.
FAU - Ma, Shuiqing
AU  - Ma S
AD  - Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China.
FAU - Tan, Xianjie
AU  - Tan X
AD  - Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China.
FAU - Zhong, Sen
AU  - Zhong S
AD  - Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China.
FAU - Song, Xiaochen
AU  - Song X
AD  - Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China.
FAU - Li, Lei
AU  - Li L
AUID- ORCID: 0000-0001-8723-3461
AD  - Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China 
      lileigh@163.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT03738969
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200820
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - China/epidemiology
MH  - Female
MH  - Humans
MH  - Hysterectomy
MH  - *Laparoscopy
MH  - Longitudinal Studies
MH  - Multicenter Studies as Topic
MH  - Neoplasm Recurrence, Local/pathology
MH  - Neoplasm Staging
MH  - Randomized Controlled Trials as Topic
MH  - Retrospective Studies
MH  - *Uterine Cervical Neoplasms/pathology/surgery
PMC - PMC7443279
OTO - NOTNLM
OT  - adult surgery
OT  - gynaecological oncology
OT  - minimally invasive surgery
COIS- Competing interests: None declared.
EDAT- 2020/08/21 06:00
MHDA- 2021/05/15 06:00
PMCR- 2020/08/20
CRDT- 2020/08/22 06:00
PHST- 2020/08/22 06:00 [entrez]
PHST- 2020/08/21 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2020/08/20 00:00 [pmc-release]
AID - bmjopen-2020-038020 [pii]
AID - 10.1136/bmjopen-2020-038020 [doi]
PST - epublish
SO  - BMJ Open. 2020 Aug 20;10(8):e038020. doi: 10.1136/bmjopen-2020-038020.