Comparative efficacy and complication rates after local treatment for cervical intra-epithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE Group
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Introduction: Local treatments for cervical intra-epithelial neoplasia (CIN) and microinvasive disease remove or ablate a cone-shaped part of the uterine cervix containing the
abnormal cells. A trend towards less radical techniques has raised concerns that this may
adversely impact the rates of precancerous and cancerous recurrence. However, there has
been no strong evidence to support such claims. We hereby describe a protocol of a
systematic review and network meta-analysis that will update the evidence and compare all
relevant treatments in terms of efficacy and complications.
Methods and Analysis: Literature searches in electronic databases (CENTRAL, MEDLINE,
EMBASE) or trial registries will identify published and unpublished randomised controlled
trials (RCTs) and cohort studies comparing the efficacy and complications amongst different
excisional and ablative techniques. The excisional techniques include cold knife, laser or
fischer cone, large loop or needle excision of the transformation zone and the ablative radical
point diathermy, cryotherapy, cold coagulation or laser ablation. The primary outcome will
be residual/recurrent disease defined as abnormal histology or cytology of any grade, while
secondary outcomes will include treatment failure rates defined as high-grade histology or
cytology, histologically-confirmed CIN1+ or histologically-confirmed CIN2+, HPV
positivity rates, involved margins rates, bleeding and cervical stenosis rates. We will assess
the risk of bias in RCTs and observational studies using tools developed by the Cochrane
Collaboration. Two authors will independently assess study eligibility, abstract the data, and
assess the risk of bias. Random-effects meta-analyses and network meta-analyses will be
conducted using the odds ratio for dichotomous outcomes and the mean difference for
continuous outcomes. The quality of the evidence for the primary outcome will be assessed
using the CINEMA tool.
abnormal cells. A trend towards less radical techniques has raised concerns that this may
adversely impact the rates of precancerous and cancerous recurrence. However, there has
been no strong evidence to support such claims. We hereby describe a protocol of a
systematic review and network meta-analysis that will update the evidence and compare all
relevant treatments in terms of efficacy and complications.
Methods and Analysis: Literature searches in electronic databases (CENTRAL, MEDLINE,
EMBASE) or trial registries will identify published and unpublished randomised controlled
trials (RCTs) and cohort studies comparing the efficacy and complications amongst different
excisional and ablative techniques. The excisional techniques include cold knife, laser or
fischer cone, large loop or needle excision of the transformation zone and the ablative radical
point diathermy, cryotherapy, cold coagulation or laser ablation. The primary outcome will
be residual/recurrent disease defined as abnormal histology or cytology of any grade, while
secondary outcomes will include treatment failure rates defined as high-grade histology or
cytology, histologically-confirmed CIN1+ or histologically-confirmed CIN2+, HPV
positivity rates, involved margins rates, bleeding and cervical stenosis rates. We will assess
the risk of bias in RCTs and observational studies using tools developed by the Cochrane
Collaboration. Two authors will independently assess study eligibility, abstract the data, and
assess the risk of bias. Random-effects meta-analyses and network meta-analyses will be
conducted using the odds ratio for dichotomous outcomes and the mean difference for
continuous outcomes. The quality of the evidence for the primary outcome will be assessed
using the CINEMA tool.
Date Issued
2019-08-02
Date Acceptance
2019-07-03
Citation
BMJ Open, 2019, 9 (8), pp.1-7
ISSN
2044-6055
Publisher
BMJ Journals
Start Page
1
End Page
7
Journal / Book Title
BMJ Open
Volume
9
Issue
8
Copyright Statement
© Author(s) (or their
employer(s)) 2019. Re-use
permitted under CC BY.
Published by BMJ. This is an open access article distributed in accordance with the
Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits
others to copy, redistribute, remix, transform and build upon this work for any
purpose, provided the original work is properly cited, a link to the licence is given,
and indication of whether changes were made. See: https://creativecommons.org/
licenses/by/4.0/.
employer(s)) 2019. Re-use
permitted under CC BY.
Published by BMJ. This is an open access article distributed in accordance with the
Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits
others to copy, redistribute, remix, transform and build upon this work for any
purpose, provided the original work is properly cited, a link to the licence is given,
and indication of whether changes were made. See: https://creativecommons.org/
licenses/by/4.0/.
Sponsor
Imperial College Healthcare NHS Trust
Identifier
https://bmjopen.bmj.com/content/9/8/e028008
Grant Number
RDD09 79560
Subjects
Ablation techniques/adverse effects
Cervical intraepithelial neoplasia/therapy
Conization/adverse effects
Recurrence
Treatment outcome
1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
Publication Status
Published
Date Publish Online
2019-08-02