The effect of circular stapler size on anastomotic stricture formation in colorectal surgery: A propensity score matched study

Kil-yong Lee; Jaeim Lee; Youn Young Park; Hyung-Jin Kim; Seong Taek Oh

doi:10.1371/journal.pone.0287595

Peer Review History

Original SubmissionJanuary 25, 2023
27 Feb 2023 Decision Letter - Fabrizio D'Acapito, Editor PONE-D-23-02247The Effect of Circular Stapler Size on Anastomotic Stricture Formation in Colorectal Surgery: A Propensity Score Matched StudyPLOS 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 Apr 13 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. 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For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. Additional Editor Comments: I believe that the reviewers have focused on the weaknesses of the paper, while also providing insights to correct them. I think some of the reviewers' considerations play a crucial role in meaningfully improving the paper: “….Since the risk profile for anastomotic stenosis and also anastomotic leaks differs significantly from ileocolic anastomoses and colorectal anastomoses, I consider the selection of the patient collective to be unsuitable. As confirmed in your data, only an evaluation of the colorectal anastomoses makes sense. … I suggest to include only those patients who underwent left colectomy or anterior resection, ….In addition, the impact of a derivative stoma should be taken in consideration during the analysis of the results. …. please could the Authors specify why the circular stapler sized > 29-mm (widely used in rectal cancer surgery) have been excluded. … Who and why chooses a 25-mm or 28/29-mm stapler?” An improvement in English would be desirable. [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: Partly Reviewer #3: No ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: 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 Reviewer #3: 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 Reviewer #3: 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 report the effect of cicular stapler size on anastomotic stricture in colorectal surgery. This is a relevant question in colorectal surgery and therefore an interesting topic. Overall, the conduct of the study is correct and the manuscript is in order. An improvement in English would be desirable. However, I have one major concern: Since the risk profile for anastomotic stenosis and also anastomotic leaks differs significantly from ileocolic anastomoses and colorectal anastomoses, I consider the selection of the patient collective to be unsuitable. As confirmed in your data, only an evaluation of the colorectal anastomoses makes sense. Reviewer #2: Thanks to the Authors for this interesting paper. I would like to make the following considerations and questions. METHODS Patients The Authors assert that the purpose of the study is to determine whether the frequency of anastomotic stricture depends on the stapler size: please could the Authors specify why the circular stapler sized > 29-mm (widely used in rectal cancer surgery) have been excluded. Procedure Do the Authors usually or always perform end-to-side anastomosis by mean a circular stapler following ileocecal resection or right colectomy? Is a linear stapler used for section or closure of any bowel stump? Who and why chooses a 25-mm or 28/29-mm stapler? Statistical analyses Please could the Authors specify the methodology for after matching analysis, for example McNemar’s test, paired t test or Wilcoxon signed rank test. RESULTS Baseline characteristics In table 1 the clinical characteristics of patients are similar but 25-mm staplers are significantly more used in benign lesions (28.3% vs 8.1% of 28/29-mm stapler group) and emergency surgery (15.1% vs 4.8% of 28/29-mm stapler group) whilst 25-mm staplers are significantly less used in colorectal anastomosis (1 out of 23 – 4.3% – left colectomy patients and 47 out of 654 – 7.2% – anterior resection patients): how do the Authors motivate these so impressive differences? Outcomes Anastomotic stenosis occurred in 6 cases, 4 in the 28/29-mm group (in 2 cases after anastomotic leak) and 2 in the 25-mm group (without any leak) and in table 3 only anastomotic leak resulted as independent risk factor for stricture at multivariate analysis: despite the small number of cases, is there any reason for stricture in patients without leak, especially in the 2 patients in the 25-mm group? Anastomotic stricture management Please could the Authors specify which stapler was used in the 3 patients that underwent operative treatment for symptomatic stricture. Was the decision of stent insertion in the patient with stenosis after left colectomy dictated by the specific oncological stage of the disease or is stent insertion part of the armamentarium of strictures’ treatment? How many finger dilatations were performed in order to obtain a permanently wide stricture site? Was pneumatic dilatation considered? Please could the Authors provide details concerning follow up duration and long-term efficacy of treatment. DISCUSSION The Authors report that the 2011 Cochrane Database Systematic Review (reference 1) showed no differences in incidence of stricture following stapled anastomosis, compared with hand-sewn anastomosis, and correctly underline the small number of patients (65) included in the two studies evaluating the outcome “anastomotic stricture” (Izbicki JR et al. Der Chirurg 1998;69:725-34, published data only; Ikeuchi H et al. Digestive Surgery 2000;17:493-496, published and unpublished data); however, all the 26 “stapled” patients included in the two above mentioned studies underwent a side-to-side ileocolic anastomosis by mean of a linear and not circular stapler, therefore these data don't seem to have a relationship with the aim of the study. Reviewer #3: This is a manuscript that aims at evaluating the effect of circular stapler size on anastomotic stricture formation in colorectal surgery. The authors found no significant differences between the two groups. However, the interpretation of the results is biased by the small number of patients included in the two groups (the sample size calculation is not mentioned) and by the inclusion of both right and left colectomies/anterior resections. I suggest to include only those patients who underwent left colectomy or anterior resection, since the incidence of anastomotic stricture is negligible after right colectomy. In addition, the impact of a derivative stoma should be taken in consideration during the analysis of the results. Lastly, the timing of anastomotic check is not clearly reported, as also the clinical relevance of the strictures (did the patients with stricture report any symptom? From the paragraph assessing the stenosis management, it seems the the clinical impact was minimal. Minor: > please number the pages > some English editing is recommended ****** 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 Reviewer #3: Yes: Marco Ettore Allaix ******** [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". 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Revision 1
19 Apr 2023 Author Response Reviewer #1: The authors report the effect of cicular stapler size on anastomotic stricture in colorectal surgery. This is a relevant question in colorectal surgery and therefore an interesting topic. Overall, the conduct of the study is correct and the manuscript is in order. An improvement in English would be desirable. However, I have one major concern: Since the risk profile for anastomotic stenosis and also anastomotic leaks differs significantly from ileocolic anastomoses and colorectal anastomoses, I consider the selection of the patient collective to be unsuitable. As confirmed in your data, only an evaluation of the colorectal anastomoses makes sense. Answer> We thank the reviewer for their comments. As per the reviewer’s recommendation, we performed a subgroup analysis for 105 patients with colorectal anastomosis. Even in this subgroup analysis, there was no difference in anastomotic stricture between the two groups. We described the relevant procedure in the revised manuscript (line 170) and included the data in supplemental tables (S1-S3). We revised the manuscript to improve the language. Reviewer #2: Thanks to the Authors for this interesting paper. I would like to make the following considerations and questions. METHODS Patients The Authors assert that the purpose of the study is to determine whether the frequency of anastomotic stricture depends on the stapler size: please could the Authors specify why the circular stapler sized > 29-mm (widely used in rectal cancer surgery) have been excluded. Answer> We appreciate your considerate comments. In our study data, only 12 (1.3%) out of a total of 894 patients used 29 mm or more. Additionally, in a study with a similar subject to ours1,2, a single group of 28/29-mm was used. Therefore, the group of “29 mm or more” was excluded. The number of patients corresponding to each stapler size in the excluded patient group has been added to Fig 1. Refereces> 1. T. Nagaoka et al. Dis Colon Rectum. 2021 Aug 1;64(8):937-945. 2. T. Reif de Paula et al. Tech Coloproctol. 2020 Apr;24(4):283-290. Procedure Do the Authors usually or always perform end-to-side anastomosis by mean a circular stapler following ileocecal resection or right colectomy? Is a linear stapler used for section or closure of any bowel stump? Who and why chooses a 25-mm or 28/29-mm stapler? Answer> At our institution, end-to-side anastomosis is always performed when performing ileocecal resection or right hemicolectomy, and a linear stapler is used for stump closure. 25-mm or 28/29-mm staplers are used entirely according to the surgeon's decision; therefore, the exact reason for this selection is unknown. We have added the relevant explanations to the procedure (line 85) and limitation sections (line 253) of the revised manuscript. Statistical analyses Please could the Authors specify the methodology for after matching analysis, for example McNemar’s test, paired t test or Wilcoxon signed rank test. Answer> After propensity score matching, the clinical characteristics were analyzed using the Mann–Whitney U test or Student’s t-test for continuous variables and the chi-squared test, Fisher’s exact test, or linear-by-linear association for categorical variables. A series of analyses related to propensity score matching was conducted using Web-based Analysis with R (prepared by web-r.org) based on the R package MatchIt. We have added this description to the methods section (line 111). RESULTS Baseline characteristics In table 1 the clinical characteristics of patients are similar but 25-mm staplers are significantly more used in benign lesions (28.3% vs 8.1% of 28/29-mm stapler group) and emergency surgery (15.1% vs 4.8% of 28/29-mm stapler group) whilst 25-mm staplers are significantly less used in colorectal anastomosis (1 out of 23 – 4.3% – left colectomy patients and 47 out of 654 – 7.2% – anterior resection patients): how do the Authors motivate these so impressive differences? Answer> The reason for the occurrence of this discrepancy is unknown, as the size of the round stapler used was entirely at the discretion of the surgeon. However, to compensate for this difference, we performed a propensity score matching. Outcomes Anastomotic stenosis occurred in 6 cases, 4 in the 28/29-mm group (in 2 cases after anastomotic leak) and 2 in the 25-mm group (without any leak) and in table 3 only anastomotic leak resulted as independent risk factor for stricture at multivariate analysis: despite the small number of cases, is there any reason for stricture in patients without leak, especially in the 2 patients in the 25-mm group? Answer> Due to the small number of patients included in our study, determining the reason for stricture occurrence in the 25-mm group without the risk factors from our study was not possible. However, considering that stricture occurred in two patients in the 28/29-mm group without leakage, we believe that there was a reason other than the stapler size. Additional research is needed to elucidate this point; therefore, we have included it in the limitations section (line 255). Anastomotic stricture management Please could the Authors specify which stapler was used in the 3 patients that underwent operative treatment for symptomatic stricture. Was the decision of stent insertion in the patient with stenosis after left colectomy dictated by the specific oncological stage of the disease or is stent insertion part of the armamentarium of strictures’ treatment? How many finger dilatations were performed in order to obtain a permanently wide stricture site? Was pneumatic dilatation considered? Please could the Authors provide details concerning follow up duration and long-term efficacy of treatment. Answer> In one patient using a 28-mm circular stapler, stricture was confirmed 95 days after surgery, and there was no further stricture after 2485 days with a single finger dilatation. In one patient who used a 25-mm circular stapler, stricture was confirmed 157 days after surgery, but there was no further stricture for 385 days after one finger dilatation. Patients who underwent left hemicolectomy using a 28-mm circular stapler developed anastomotic stricture after 60 days, and a stent was inserted to resolve the stricture. After stent insertion, symptoms improved, and the patients were discharged; however, follow-up was lost thereafter. When the medical records were checked, pneumatic dilatation was not considered for this patient. We have added these details to the revised manuscript (line 186). DISCUSSION The Authors report that the 2011 Cochrane Database Systematic Review (reference 1) showed no differences in incidence of stricture following stapled anastomosis, compared with hand-sewn anastomosis, and correctly underline the small number of patients (65) included in the two studies evaluating the outcome “anastomotic stricture” (Izbicki JR et al. Der Chirurg 1998;69:725-34, published data only; Ikeuchi H et al. Digestive Surgery 2000;17:493-496, published and unpublished data); however, all the 26 “stapled” patients included in the two above mentioned studies underwent a side-to-side ileocolic anastomosis by mean of a linear and not circular stapler, therefore these data don't seem to have a relationship with the aim of the study. Answer> As per the reviewer’s comment, we have deleted the relevant section. Reviewer #3: This is a manuscript that aims at evaluating the effect of circular stapler size on anastomotic stricture formation in colorectal surgery. The authors found no significant differences between the two groups. However, the interpretation of the results is biased by the small number of patients included in the two groups (the sample size calculation is not mentioned) and by the inclusion of both right and left colectomies/anterior resections. I suggest to include only those patients who underwent left colectomy or anterior resection, since the incidence of anastomotic stricture is negligible after right colectomy. In addition, the impact of a derivative stoma should be taken in consideration during the analysis of the results. Lastly, the timing of anastomotic check is not clearly reported, as also the clinical relevance of the strictures (did the patients with stricture report any symptom? From the paragraph assessing the stenosis management, it seems the the clinical impact was minimal. Answer> We thank the reviewer for their considerate comments. Following the reviewer’s recommendation, we performed a subgroup analysis for 105 patients with colorectal anastomosis and evaluated the effect of diversion (stoma) on anastomotic stricture (added: line 170; Table S1, S3). Finally, we confirmed anastomotic stricture with colonoscopy for all patients (added: line 89). Attachments Attachment Submitted filename: Response_to_Reviewers.docx https://doi.org/10.1371/journal.pone.0287595.r002
8 Jun 2023 Decision Letter - Fabrizio D'Acapito, Editor The Effect of Circular Stapler Size on Anastomotic Stricture Formation in Colorectal Surgery: A Propensity Score Matched Study PONE-D-23-02247R1 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, Fabrizio D'Acapito, Ph.D,M.D. Academic Editor PLOS ONE Additional Editor Comments (optional): I congratulate the authors for their review work. The topic has important clinical relevance for those who deal with colo-rectal resective surgery on a daily basis. The input that the paper provides may be of assistance to the surgeon and a boost to launch further research in this field. 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 #3: 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 #3: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #3: 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 #3: 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 #3: 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 #3: The authors have replied to the questions point-by-point. All comments have been adequately assessed. ****** 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 #3: No ******** https://doi.org/10.1371/journal.pone.0287595.r003
Formally Accepted
15 Jun 2023 Acceptance Letter - Fabrizio D'Acapito, Editor PONE-D-23-02247R1 The Effect of Circular Stapler Size on Anastomotic Stricture Formation in Colorectal Surgery: A 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. Fabrizio D'Acapito Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0287595.r004

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