Small hiatal hernia and postprandial reflux after vertical sleeve gastrectomy: A multiethnic Asian cohort

Tiffany Jian Ying Lye; Kiat Rui Ng; Alexander Wei En Tan; Nicholas Syn; Shi Min Woo; Eugene Kee Wee Lim; Alvin Kim Hock Eng; Weng Hoong Chan; Jeremy Tian Hui Tan; Chin Hong Lim

doi:10.1371/journal.pone.0241847

Peer Review History

Original SubmissionMarch 5, 2020
26 Aug 2020 Decision Letter - Chun Chieh Yeh, Editor PONE-D-20-04688 Small hiatal hernia and postprandial reflux after vertical sleeve gastrectomy: a multiethnic Asian cohort PLOS ONE Dear Dr. Lye, 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 reply and give appropriate response specific to the reviewers' comments. Final decision will depend on your reply. Thanks. ============================== Please submit your revised manuscript by Oct 10 2020 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. 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Please reply and give appropriate response specific to the reviewers' comments. Final decision will depend on your reply. Thanks. [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: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: N/A ****** 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: No 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: The authors present a retrospective analysis of patients undergoing laparoscopic sleeve gastrectomy in a multi-ethnic Asian cohort, focusing on GERD outcomes as a function of the presence/absence of small hiatal hernias. The study is well written and provides a systematic assessment from preoperative evaluation in lieu of intraoperative assessment alone as several other studies have. Study data could be anonymized and posted publicly. Studies cited in the current evidence table should be listed in the references section. The method of assessment for hiatal hernial in each study may be a beneficial addition for readers. Is it know whether there was any reduction in PPI dose following surgery? Reviewer #2: 1. Please discuss in discussion section that if 75% of patients develop de novo GERD then why continue to perform sleeve gastrectomy? That is an excessive amount of de novo GERD. 2. In method section, please state the questionnaire that was used to assess GERD preop and postop. Is the GERD questionnaire validated? 3. The methods section stated that the patient answered if GERD is resolve, improved, unchanged or worsen. However, the results section in the tables only showed if GERD is presence or not in the postoperative period. Please show details of results such as how many patients with continued GERD symptoms but "improved" compared to preop. ****** 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/. 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Revision 1
19 Sep 2020 Author Response Dear reviewers, We appreciate and thank you for your time spent and for the invaluable comments that will certainly help to improve the quality and robustness of our manuscript. I do hope that your questions and suggestions have been adequately addressed in the responses below, as well as in the revised manuscript. Responses to Reviewer #1 1) Study data could be anonymized and posted publicly. We have anonymized and submitted the study data. 2) Studies cited in the current evidence table should be listed in the references section. The citations have been added into the revised manuscript. 3)The method of assessment for hiatal hernia in each study may be a beneficial addition for readers. In majority of the studies on LSG and concomitant hiatal hernia (HH) repair, most of them diagnose the presence of HH with pre-operative upper endoscopy. Soricelli et al described that finding a macroscopically evident fingerprint indentation of the diaphragm above the esophageal emergence from the diaphragm is considered suspicious for HH, necessitating careful exploration of the diaphragmatic crura. In several of the studies, the presence of a HH was also diagnosed intraoperatively. El Chaar et al reported routine dissection of the angle of His, taking down the phrenoesophageal ligament and mobilization of the fat pad in order to identify and measure HH, regardless of whether HH was diagnosed on upper endoscopy or not. In our unit we do not perform this routinely for small hiatal hernias as we believed that disruption of the integrity of the sling fibres of Helvetius at the esophagogastric junction may potentially contribute to increased reflux. In 2 studies (Satonicola, Samakar), all patients also underwent a preoperative UGI contrast study. However, Satonicola et al qualified that contrast study may be able to diagnose a large HH, but the diagnosing of small HH would be challenging. In the study by Samakar et al, only UGI contrast study only revealed HH in 34.5% of patients, and the remaining HH were diagnosed intra-operatively. 4) Is it known whether there was any reduction in PPI dose following surgery? Majority of the studies cited have had no data presented on changes in the dosage of PPI after surgery. Only Soricelli et al reported 80.4% of the patients had discontinuation of PPI after LSG with HH repair, and 19.6% of patients needed reduced dose of PPI (40mg/d to 15mg/d). Responses to Reviewer #2 1) Please discuss in the discussion section that if 75% of patients develop de novo GERD then why continue to perform sleeve gastrectomy? The incidence of de novo GERD after laparoscopic sleeve gastrectomy decreases with time post operatively. Himpens et al. demonstrated in a prospective randomized study that the incidence of de novo GERD continues to decrease with time, dropping from 21.8% after 1 year, to 3.1% after 3 years from the time of surgery. It was postulated that the rationale for this could be due to a gradual increase in gastric tube compliance and gastric emptying with time. From our data, the 74% of patients that develop de novo GERD in our study reflects the total number of patients that develop new GERD symptoms at any point of time after surgery, and thus the incidence is high especially within the first 6 months, but is expected to improve with time. Our study data shows that after 6 months, there was in fact improvement of de novo GERD from 74% to 48.5%. This may be due to the reasons stated above, but we also postulate that eating behavior plays an important role as the patients have a tendency to overeat during the early post-operative period, resulting in increased intragastric pressure and higher likelihood of reflux. Dietary adjustment takes time and subsequently results in improvement or resolution of GERD symptoms. 2) In the methods section, please state the questionnaire that was used to assess GERD preop and postop. Is the GERD questionnaire validated? Although our unit’s questionnaire is not validated, it was more relevant to post sleeve gastrectomy subjects as it takes into account smoking and alcohol history, responses to acid suppression medication and differentiation of acid reflux versus volume reflux. As mentioned in our discussion, a significant proportion of post-operative GERD symptoms in patients who have undergone laparoscopic sleeve gastrectomy are related to regurgitation and volume reflux. Althuwani et al. had concluded that 35.7% of reflux is in fact non-acid regurgitation. The same questionnaire was used by Lim et al in the study “Resolution of Erosive Esophagitis after Conversion from Vertical Sleeve Gastrectomy to Roux-en-Y Gastric Bypass” (Obesity Surgery, August 2020). They explained that current validated questionnaires like GERD-Q or GERD-HRQL are useful instruments to assess acid reflux but they do not measure symptoms due to volume reflux like postprandial regurgitation. 3) The methods section stated that the patient answered if GERD is resolved, improved, unchanged or worsen. However, the results section in the tables only showed if GERD is present or not in the postoperative period. Please show details of results such as how many patients with continued GERD symptoms but "improved" compared to preop. Of the 86 patients with GERD symptoms before surgery, 20 patients had resolution of their symptoms. Another 10 patients reported ongoing but improved GERD symptoms. The rest of the patients had no change or worsening of their symptoms after LSG. Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0241847.r002
22 Oct 2020 Decision Letter - Chun Chieh Yeh, Editor Small hiatal hernia and postprandial reflux after vertical sleeve gastrectomy: a multiethnic Asian cohort PONE-D-20-04688R1 Dear Dr. Lye, 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, Chun Chieh Yeh, M.D., Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): After revisions, I consider the current article could be accepted because the revised contents can response to our reviewers' comments specifically. In addition, a kind suggestion: in your rebuttal letter, you should point out specific locations that the revised content are added. 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: (No Response) ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: (No Response) ****** 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: (No Response) ****** 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: (No Response) ****** 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: (No Response) ****** 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 https://doi.org/10.1371/journal.pone.0241847.r003
Formally Accepted
28 Oct 2020 Acceptance Letter - Chun Chieh Yeh, Editor PONE-D-20-04688R1 Small hiatal hernia and postprandial reflux after vertical sleeve gastrectomy: a multiethnic Asian cohort Dear Dr. Lye: 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. Chun Chieh Yeh Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0241847.r004

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