Postoperative effects of laparoscopic Hartmann reversal: A multicenter propensity score matched study

Kil-yong Lee; Jaeim Lee; Seong Taek Oh; Chul Seung Lee; Nam Suk Kim; Ju Myung Song; Ri-Na Yoo; Byung Jo Choi

doi:10.1371/journal.pone.0286562

Peer Review History

Original SubmissionFebruary 24, 2023
4 Apr 2023 Decision Letter - Yasunori Sato, Editor PONE-D-23-05434 Postoperative effects of laparoscopic Hartmann reversal: A multicenter propensity score matched study. PLOS ONE Dear Dr. Lee, 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 May 19 2023 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. 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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 [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: Yes Reviewer #2: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: No ****** 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: Yes 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: Title: Postoperative effects of laparoscopic Hartmann reversal: A multicenter propensity score matched study. The title is in line with study objectives and the results Abstract: Structured and well written Background: Detailed information on statement of problem as well as rational for the study clearly presented. Methods: Fairly well described. • Study design should be mentioned even though it is apparent from the methodology. • Minimum sample size for the study was not calculated. This is desirable, as this will show whether the sample size in this study meets the minimum calculated sample size. If the sample size used is less than the calculated minimum sample size, then this can be a limitation in the study. Result: Well written in details with relevant tables and figures • The first column for most of the tables are without a label • The state number of days for POI, hospital stay, etc are not really clear. Are these mean values or median? If it is mean value, please indicate it in the sentence and provide the standard deviation (SD) as well. • Line 126 - Frequency cannot be in percentage. Please correct it. Is it the prevalence? Discussion: The study findings are well discussed, with study limitations provided. Conclusion: Clearly written with appropriate recommendation. Reviewer #2: The author focused to the short-term outcomes of reversal Hartmann operation and compared the advantages of laparoscopic and opern surgery in this operation. They enrolled the patients from multi-institutions retrospectively and used the propensity score matched analysis for deep statistical analysis. From the analysis, the author have concluded that laparoscopic Hartmann reversal (LHR) is better method for fast recovery from the surgery and to prevent the postoprative bowel obstrution than open Hartmann reversal (OHR). Overall, the analysis seems to be fair and the results of this manuscript are similar to the previous studies and I agree with it. As the author pointed out, the study which reported the outcome of Hartmann reversal operation is not that many and these previous publications are mainly from single institution. This presented study is multi-instituional study with propensity score matced analysis and these background seems to strengthen the result compared to the previous studies. However, there are several concerns in this study which I want to point out. 1. As the author pointed out, the peritoneal adhesion will be the challenge to perform LHR. I feel that the conversion rate of LHR is another important outcome and I do not understand why the author excluded the 15 conversion cases from the analysis. It is more important to know how the LHR is difficult and conversion to open surgery may happen. Looking into the result, it seems that about 15% of patients were converted to open surgery and I recommend the author to analyze and discuss more deeply about it. 2. In Table 1, I see the data of the previous surrgery (Hartmann method) but this data is not presented in Table 2. This is very important imformation to consider the result of matching and I highly recommend to include it. 3. Hartmann operation will be considered when the anatomosis is considered to be difficult. However, reason of this decision will be various kinds of things; for example, perforation, severe comorbidity, elderly patients, profiency of the surgeon, etc. It would be better to include more specifc data why the patients underwent Hartmann operation at the beginning. 4. As the author mentioned in the limitation, there will be a selection bias since the patients with advanced cancer cannot undergo Hartmann reversal when they are under chemotherapy. It might be better to show how many patients underwent Hartmann surgery and how many had Hartmann reveersal. 5. The frequency of POI seems to be quite different. Is there any difference in the required treatment for these patient comparing LHR and OHR group? Were there any case which needed another surgery to treat POI? The primary outcome was set as POI and I recommend the author to analyze more deeply in it. 6. Although there was no significant difference, I am quite surprised that the incisional hernia was more frequent in LHR group. Why do you think this happened? ****** 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: Yes: Prof. Tanimola Makanjuola Akande 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. Attachments Attachment Submitted filename: PONE-D-23-05434_reviewer.pdf Attachment Submitted filename: Comment PLOS One - PONE-D--23-05434.docx https://doi.org/10.1371/journal.pone.0286562.r001
Revision 1
19 Apr 2023 Author Response Review Comments to the Author Reviewer #1: Title: Postoperative effects of laparoscopic Hartmann reversal: A multicenter propensity score matched study. The title is in line with study objectives and the results Abstract: Structured and well written Background: Detailed information on statement of problem as well as rational for the study clearly presented. Methods: Fairly well described. • Comment: Study design should be mentioned even though it is apparent from the methodology. � We thank the reviewer for the considerate comments. Accordingly, we have indicated the study design at the beginning of the methods. • Comment: Minimum sample size for the study was not calculated. This is desirable, as this will show whether the sample size in this study meets the minimum calculated sample size. If the sample size used is less than the calculated minimum sample size, then this can be a limitation in the study. � According to the reviewer’s comments, we have calculated sample size. As reported by Ng et al. [1] and Yang et al. [2], with 80% power and alpha 0.05, the sample size required for each group was 60 patients. Therefore, in this study, the number of samples included is appropriate, with a total of 126 patients and 63 patients in each group; the power was confirmed to be about 82% in the power analysis. This information has been added it in the “Patients” and “Results” section. References 1. Ng DC, Guarino S, Yau SL, Fok BK, Cheung HY, Li MK et al. Laparoscopic reversal of Hartmann's procedure: safety and feasibility. Gastroenterol Rep (Oxf). 2013;1(2):149-52. doi:10.1093/gastro/got018. 2. Yang PF, Morgan MJ. Laparoscopic versus open reversal of Hartmann's procedure: a retrospective review. ANZ J Surg. 2014;84(12):965-9. doi:10.1111/ans.12667. Result: Well written in details with relevant tables and figures • Comment: The first column for most of the tables are without a label � Accordingly, we have added the label to the first column. • Comment: The state number of days for POI, hospital stay, etc are not really clear. Are these mean values or median? If it is mean value, please indicate it in the sentence and provide the standard deviation (SD) as well. � The number of days for hospital stay and the time to solid diet are described as the median. These have been added to the results section. • Comment: Line 126 - Frequency cannot be in percentage. Please correct it. Is it the prevalence? � This indicates the prevalence of POIs in each group. According to the reviewer’s comment, we have changed it to the number of occurrences as well as the percentage. Discussion: The study findings are well discussed, with study limitations provided. Conclusion: Clearly written with appropriate recommendation. Reviewer #2: The author focused to the short-term outcomes of reversal Hartmann operation and compared the advantages of laparoscopic and open surgery in this operation. They enrolled the patients from multi-institutions retrospectively and used the propensity score matched analysis for deep statistical analysis. From the analysis, the author have concluded that laparoscopic Hartmann reversal (LHR) is better method for fast recovery from the surgery and to prevent the postoprative bowel obstrution than open Hartmann reversal (OHR). Overall, the analysis seems to be fair and the results of this manuscript are similar to the previous studies and I agree with it. As the author pointed out, the study which reported the outcome of Hartmann reversal operation is not that many and these previous publications are mainly from single institution. This presented study is multi-instituional study with propensity score matced analysis and these background seems to strengthen the result compared to the previous studies. However, there are several concerns in this study which I want to point out. 1. Comment: As the author pointed out, the peritoneal adhesion will be the challenge to perform LHR. I feel that the conversion rate of LHR is another important outcome and I do not understand why the author excluded the 15 conversion cases from the analysis. It is more important to know how the LHR is difficult and conversion to open surgery may happen. Looking into the result, it seems that about 15% of patients were converted to open surgery and I recommend the author to analyze and discuss more deeply about it. � We appreciate the reviewer’s considerate comments. The initial intention of the group that underwent conversion was LHR; thus, if it were analyzed by intention-to-treat (ITT) method, this group should be analyzed by putting it in the LHR group. However, because the surgical method itself was open, it was excluded from our study. Nonetheless, according to the reviewer's opinion, we performed further analysis to investigate whether a conversion group differs from other groups. Although the surgical time was longer in this group compared to that in the LHR group, there was no difference in other postoperative complications and POI. We have added a supplement table summarizing the analysis of the three groups and have summarized the results in the discussion section. 2. Comment: In Table 1, I see the data of the previous surgery (Hartmann method) but this data is not presented in Table 2. This is very important information to consider the result of matching and I highly recommend to include it. � In the group that underwent open Hartmann's reversal, remarkably few cases were present where the previous operation was laparoscopic Hartmann's operation (3.9%); thus, we excluded Hartmann's method from matching in PSM and included this as a limitation in the discussion section. However, according to the reviewer's opinion, we have added the Hartmann method to Table 2 as well. 3. Comment: Hartmann operation will be considered when the anastomosis is considered to be difficult. However, reason of this decision will be various kinds of things; for example, perforation, severe comorbidity, elderly patients, proficiency of the surgeon, etc. It would be better to include more specifc data why the patients underwent Hartmann operation at the beginning. � Our study focused on Hartmann's reversal and investigated data from multi-institutional electric medical records. Furthermore, there were cases where Hartmann's operation was performed at institutions other than our six institutions, and there were no records from the other hospital; even though there was a surgical record for Hartmann's operation, there was no mention of the reason why Hartmann's operation was performed, and we had to exclude that item. Therefore, we have added this as a limitation of our study in the discussion section. 4. Comment: As the author mentioned in the limitation, there will be a selection bias since the patients with advanced cancer cannot undergo Hartmann reversal when they are under chemotherapy. It might be better to show how many patients underwent Hartmann surgery and how many had Hartmann reveersal. � According to the reviewer's opinion, the number of patients who underwent Hartmann's surgery in our institutes was investigated. In total, 1076 patients underwent Hartmann's operation in our hospital, and among them, 306 patients underwent Hartmann reversal. The remaining 31 patients who underwent Hartmann reversal in our institutes were patients who had undergone Hartmann's operation at other hospitals. This has been added to Figure 1. 5. Comment: The frequency of POI seems to be quite different. Is there any difference in the required treatment for these patient comparing LHR and OHR group? Were there any case which needed another surgery to treat POI? The primary outcome was set as POI and I recommend the author to analyze more deeply in it. � In the LHR group, two POI patients showed an improvement in symptoms at 2 and 3 days, respectively, after L-tube insertion with parenteral nutritional support. However, one patient underwent laparoscopic adhesiolysis with transverse colectomy to resolve adhesions. Of 13 POI patients in the OHR group, three patients showed spontaneous improvement in their symptoms without L-tube insertion. However, one patient underwent open adhesiolysis with T-colostomy to resolve the adhesion. We have added these in the results section. 6. Comment: Although there was no significant difference, I am quite surprised that the incisional hernia was more frequent in LHR group. Why do you think this happened? � The exact cause is not known, but the occurrence of incisional hernia was confirmed by CT; since CT was performed in only about 38 out of 63 patients in each group, this may have resulted in a difference in incidence rates. Attachments Attachment Submitted filename: Response to Reviewers_final.docx https://doi.org/10.1371/journal.pone.0286562.r002
9 May 2023 Decision Letter - Yasunori Sato, Editor PONE-D-23-05434R1Postoperative effects of laparoscopic Hartmann reversal: A multicenter propensity score matched study.PLOS ONE Dear Dr. Lee, 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 Jun 23 2023 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: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Yasunori Sato Academic Editor PLOS ONE Journal Requirements: Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] 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 Reviewer #2: 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 Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: 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 Reviewer #2: 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 Reviewer #2: 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: Authors have addressed all the issues and suggestions raised in the earlier review quite satisfactorily. Reviewer #2: Thank you for the correction. Most of my comments are fully addressed. One last comment from me is below. 1. I recommend the author to exclude the details for incisional hernia. Author have pointed out that almost half of patients did not have CT evaluation. Considering this fact, this result seems to be missleading. ****** 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: Yes: Prof. Tanimola Akande 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. Attachments Attachment Submitted filename: PONE-D-23-05434_R1.pdf https://doi.org/10.1371/journal.pone.0286562.r003
Revision 2
10 May 2023 Author Response Reviewer #1: Authors have addressed all the issues and suggestions raised in the earlier review quite satisfactorily. � We thank the reviewer for reviewing the revised manuscript. Reviewer #2: Thank you for the correction. Most of my comments are fully addressed. One last comment from me is below. 1. I recommend the author to exclude the details for incisional hernia. Author have pointed out that almost half of patients did not have CT evaluation. Considering this fact, this result seems to be missleading. � We thank the reviewer for the considerate comments. Accordingly, we have excluded the details of incisional hernia from the revised manuscript. Attachments Attachment Submitted filename: Response_to_Reviewers.docx https://doi.org/10.1371/journal.pone.0286562.r004
19 May 2023 Decision Letter - Yasunori Sato, Editor Postoperative effects of laparoscopic Hartmann reversal: A multicenter propensity score matched study. PONE-D-23-05434R2 Dear Dr. Lee, 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, Yasunori Sato Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0286562.r005
Formally Accepted
25 May 2023 Acceptance Letter - Yasunori Sato, Editor PONE-D-23-05434R2 Postoperative effects of laparoscopic Hartmann reversal: A multicenter propensity score matched study. Dear Dr. Lee: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. 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. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Yasunori Sato Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0286562.r006

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