Clip Closure and PuraStat for Prevention of Clinically Significant Delayed Bleeding after Colorectal Endoscopic Submucosal Dissection: A Prospective, Observational Study
, Dana Bilous 1,2, Andrei Gîla 1,2, Daniel-Corneliu Leucuta 3, Daniela Mihailă 2, Adrian Tulin 1,2, Anca Gheorghiu 2, Elena Tianu 2 and Cătălina Vlăduț 1,2
Round 1
Reviewer 1 Report
Comments and Suggestions for Authors1. If 0 out of 14 clip closure bled versus 3 out of 27 non-clip closure bled - though p value is not significant, this is clinically significant. To me, this actually is clinically meaningful and thus it should be reflected in your conclusion, abstract and entire manuscript. You CANNOT conclude solely based on p value but have to contextualize the results in clinical application and to me (and i believe it should be same for authors, other reviewer, editors etc) that 0 out of 14 versus 3 out of 27 should not be disposed as not significant but potentially clinically meaningful and further validation is necessary. You cannot conclude this as not significant. Please amend this entirely in your manuscript.
2. Page 1 line 45 "for rebleeding is 8.9%" -- do you mean that purastat efficacy for rebleeding patients is only 8.9%? That is what it means actually. Correct the grammar if this is untrue.
3. Page 2 line 51-53 --"all the patients.....was deemed feasible'... There is grammar error. All the patients....were .... (not was). Please correct this kind of errors as i will not focus on such errors anymore.
4. Why gastroscope was used for rectal lesions and not a colonoscope itself? Were all patients already diagnosed and than referred, i.e. you knew the location of lesion etc.
5. Table 1 need to tell readers full form of LST NICE etc short forms as a foot note.
6. Line 110 and 111 --- do i read it correctly that a 100mm adenoma case was scheduled and planned for ESD? (considering that you did a prospective study, this must be true!, and if true, this is something very awkward planning) - please explain.
7. Table 1 should include details about antiplatelet or anticoagulant usage.
Comments on the Quality of English LanguagePlease tidy up.
Author Response
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Author Response File: 
Author Response.pdf
Reviewer 2 Report
Comments and Suggestions for AuthorsDear colleagues ! I propose : 1) to add "Methods"in "Abstract" at the line 18 the short information about pathologies, which were treated by ESD ; 2) to exclude from "Keywords" next combination of words : "muscle retracting sign" and "colorectal mixed neuroendocrine adenocarcinoma"; 3) to include in "Keywords":delayed bleeding and colorectal tumors . For my opiion the sentence at the lines 96-98 need the supplement about fifth lesion bordering the dentate line. I didn't understood the numbers (5,3 and 1) in the position "Particular locations" in the Table1. For the readers may be interesting to know about the reasons of untreated wall defects in 6 cases (line 129). My congratulations with so important paper and very scilled "Discussion".
Author Response
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Author Response File: Author Response.pdf
Reviewer 3 Report
Comments and Suggestions for Authors1. The background in the abstract was included, but the research's aim was not described.
2. The abstract and results sections present the 95% confidence intervals or some statistical values obtained from the univariate analysis, but we did not find the corresponding data values in the tables provided in the manuscript.
3. All three cases of delayed bleeding occurred in the rectum, where Purastat was used (6/22). In contrast, there were only 2 cases out of 16 in the colon, which is too few for comparison.
4. People with a history of bleeding from internal hemorrhoids are more prone to bleeding. Having a history of hypertension and not taking medication regularly are both risk factors for postoperative bleeding. These medical history should be described in the manuscript.
5. The post-ESD bleeding in one case occurred 9 days after the procedure. Was it related to diet or physical activity? These aspects were not discussed.
6. Delayed bleeding may also be related to the depth of infiltration.
7. There are literature reports indicating that lesion size >50 mm, use of antithrombotic drugs, age >75 years, ASA score III/IV, rectal location, and longer surgical time are independent risk factors for CSDB after ESD. The authors should conduct a comprehensive discussion.
Comments on the Quality of English LanguageIn this sentence "CSDB occurred in 3 out 38 lesions (7.9%, 95% CI 20 [1.7 – 21.4%]), exclusively after rectal ESD (3 of 22 rectal lesions vs. 0 of 16 colonic lesions, p = 0.249)" , it'd better add "of" behind "3 out".
Author Response
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Author Response File: Author Response.pdf
Round 2
Reviewer 3 Report
Comments and Suggestions for AuthorsAgree to publish the revised manuscript
