Peer review report 1 on ``Defunctioning stoma- a ...

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[email protected]. DOI of published article: http://dx.doi.org/10.1016/j.amsu.2017.07.044. Contents lists available at ScienceDirect. Annals of Medicine ...
Annals of Medicine and Surgery 13 Supplement 1 (2017) S238

Contents lists available at ScienceDirect

Annals of Medicine and Surgery journal homepage: www.annalsjournal.com

Peer Review Report

Peer review report 1 on “Defunctioning stoma- a prognosticator for leaks in low rectal restorative cancer resection” 1. Original Submission 1.1. Recommendation Reject

1.2. Comments to the author This was an interesting read and a clinically relevant paper but it requires some significant modifications as detailed below: 1) The authors have given a very extensive background to the problem with LAR, anastomotic leak, management strategy and Covering loop ileostomy. Most of this can be moved to discussion as most of the issues identified in the background have not been answered in this study (e.g. use of bowel prep and its impact on leak rates) and do not add anything to the background. 2) The authors mention only 3 anastomotic leaks in the study. How long was the follow up? How was this confirmed? Was there a policy to do contrast enema, CT to endoscopy for this? If so, were all patients subjected to similar testing or was this a selective approach? This has implications for the study for accurate reporting of leak rates as subclinical leaks are always possible and may have been missed if all patients were not subjected to the same investigative policy. 3) Male to female ratio of 3:1 is incorrect (28/17). This needs to be corrected throughout. Also, there are no population demographics provided i.e. pre-operative risk factors etc. This need to be detailed as well please. 4) The use of means and averages in this study skews the data in my opinion. This is a very small sample size with a wide age range. The authors have not mentioned anything regarding distribution testing and therefore median and interquartile ranges would be a much better representative in this situation.

DOI of published article: http://dx.doi.org/10.1016/j.amsu.2017.07.044. http://dx.doi.org/10.1016/j.amsu.2017.07.066 2049-0801

5) Problems related to primary procedure and the reversal procedure should be presented separately. At present the results are combined together making it difficult to reach any meaningful conclusions. 6) 10/45 patients have experienced some sort of complication. Considering that 5 patients were still waiting for reversal, this gives a complication rate of 10/40¼ 25%. The authors need to comment on this at length in the discussion as this can raise questions regarding the safety of the procedure. 7) The primary outcome measure of “to detect whether loop ileostomy reduces risk of loop ileostomy or at least mitigate the consequence of leak” is very confusing. I can't make out as to how loop ileostomy reduces the risk of itself. As far as mitigation of consequences is concerned, it would require a comparative group and this study does not include a comparative group. So I can't see as to how this primary outcome measure was identified and how the analysis provides any answers to this. 8) Please include details of the statistical analysis in the materials and methods section. 9) Parastomal hernia was repaired in 12 patients. This should be 12/27. Authors should comment on the parastomal hernia rates seen in their study in discussion and compare it to literature available. 10) The abstract and the whole paper needs language editor review for publishing. Its readability statistics are very low at present and it will require a major re-write for grammatical and language reasons. Fayyaz Ali Khan Mazari, M.Sc., M.S., Ph.D., F.R.C.S., F.E.B.S, TIG National Fellow Nottingham University Hospitals NHS Trust, Nottingham Breast Institute, Nottingham City Hospital, Hucknall Road, Nottingham, NG5 1PB, United Kingdom E-mail addresses: [email protected], [email protected].