PONE-D-20-33497

Complications of surgical treatments for early-stage cervical cancer: a systematic review and meta-analysis

PLOS ONE

Dear Dr. Wang,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by Apr 12 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

We look forward to receiving your revised manuscript.

Kind regards,

Antonio Simone Laganà, M.D., Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments:

The topic of the manuscript is interesting. Nevertheless, the reviewers raised several concerns: considering this point, I invite authors to perform the required major revisions.

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. Thank you for stating the following in the Acknowledgments Section of your manuscript:

"The study was funded by the Capital’s Funds for Health Improvement and Research in China. (2020-2-8022)"

We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form.

Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows:

"YES - Specify the role(s) played"

Please include your amended statements within your cover letter; we will change the online submission form on your behalf.

3. PLOS requires an ORCID iD for the corresponding author in Editorial Manager on papers submitted after December 6th, 2016. Please ensure that you have an ORCID iD and that it is validated in Editorial Manager. To do this, go to ‘Update my Information’ (in the upper left-hand corner of the main menu), and click on the Fetch/Validate link next to the ORCID field. This will take you to the ORCID site and allow you to create a new iD or authenticate a pre-existing iD in Editorial Manager. Please see the following video for instructions on linking an ORCID iD to your Editorial Manager account: https://www.youtube.com/watch?v=_xcclfuvtxQ

4. Please amend either the abstract on the online submission form (via Edit Submission) or the abstract in the manuscript so that they are identical.

5. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Yes

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: No

Reviewer #2: Yes

**********

3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: No

Reviewer #2: Yes

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: I was pleased to revise the manuscript entitled “Complications of surgical treatments for early-stage cervical cancer: a systematic review and meta-analysis” (Manuscript Number: PONE-D-20-33497).

In my honest opinion, the topic is interesting enough to attract the readers’ attention. Nevertheless, authors should clarify different points.

In general, the Manuscript may benefit from some major revisions, as suggested below:

- All the text needs a minor language revision in order to improve readability, some typos and grammatical errors.

- Title. I would suggest revising the title to provide more details regarding the review aim. If you are focusing on a comparison between MIS and open surgery, it have to be clear in the title.

- Abstract. I would suggest improving the method section of the abstract providing the inclusion criteria following the PICO system. The present form is too generic.

- The introduction regarding the surgical approach for cervical cancer is not update. After the LACC trial, it was clearly demonstrated that MIS for cervical cancer is associated with worse overall survival. Therefore, discussing the surgical morbidity have to be done clarifying better the actual role of MIS in cervical cancer.

- Methods. Search strategy and study selection should be improved. Line 99 is conflicting with lines 111-112. I would suggest reporting the study selection following the PICO system.

- Methods. Was a third investigator involved in the case of disagreement.

- Methods. How were the type of complications defined?

- Results, I would suggest providing some data regarding the absolute risk difference and not only the OR. If it is not possible in results. I would suggest discussing this point in the discussion. A change in risk from 10 to 20% and from 0.01 to 0.02 have the same OR but completely different clinical meaning.

- Data regarding the pooled cumulative incidence of complications should be provided.

- Jadad scale in Table 1 is not reported in the study’s methods.

- Lines 314-317. I would suggest provided references supporting the statements.

- Regarding study limitations, how complications were classified and standardized for this review should be clearly reported to allow reproducibility.

- I would suggest discussing better the concept regarding the pooling of studies with completely different study designs.

- The main concern regarding the current review is the background, which is completely out of the more recent literature regarding surgical approach for cervical cancer. This required extensive improvement. Refer to: PMID: 30380365; PMID: 32320800

Reviewer #2: The title of this manuscript does not well represent the topic—this is specifically a comparison of complications between minimally invasive and open surgical treatments for cervical cancer.

Why did the authors choose to focus only on studies that compare the two (or three) surgical methods and exclude case series? Given that only one study was randomized, it seems that they would have had a much larger number of articles without losing substantial rigor.

It would be helpful to ground more general readers into the stage at which women would be candidates for surgical treatment, and how that may differ in LMICs compared to HICs where there are more resources available for radiation.

Line 87: The aim of the meta-analysis was to compare the published rates of common intra-operative and post-operative complications.

Was there a reason that the authors did not abstract the disease stage? Was this not presented in the published studies?

Line 169: What does BMI mean in this context? Do you mean that in some studies, median BMI was reported vs mean vs no BMI description?

Lines 213-217: This needs to be worded more clearly, as the authors are stating that there is an increased odds of aggregate fistula formation, but when disaggregated, the odds of formation of individual fistula types were not increased, likely due to the small numbers in each category. The word “overall” in line 216 is confusing.

Discussion:

The second sentence in the discussion states that the authors aimed to offer new opinions for prognostic indicators in MIS—this was not described in the methods and none of the results would suggest prognostic indicators were evaluated.

Line 281: would change that sentence to read that intestinal obstruction is often related to abdominal adhesions, which are more likely to form after abdominal surgery. I would avoid the phrase “indirectly proved.”

Lines 297-302: There was no difference in fistula rates between ORH and MIS. Given the low numbers of fistulas seen overall, I would avoid making the over-conclusions that the authors may be doing in lines 298-302.

I would suggest that the entire paragraph 284-302 can be combined with the preceding two paragraphs, preferably the urinary complication paragraph. The second sentence, describing the incidence of complications as depending on the surgeon’s skills, is general to all of the complications, not just fistula formation.

Additional limitations that were not described include the lack of data on the surgeon level or years of experience, and additional patient morbidities (in addition to prior surgeries).

Table 2 needs a more descriptive title.

Figure 1: Include the reasons that articles were excluded and the #s per reason at the abstract and full-text stage in the flowchart.

**********

6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

Comparison of the complications between minimally invasive surgery and open surgical treatments for early-stage cervical cancer: a systematic review and meta-analysis

PONE-D-20-33497R1

Dear Dr. Wang,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Antonio Simone Laganà, M.D., Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Authors performed the required corrections, which were positively evaluated by the reviewers. I am pleased to accept this paper for publication.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: In the new version of the manuscript, authors addressed all recommended revisions, and I appreciated the manuscript improvement.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No