Lateral Internal Sphincterotomy with Skin Grafting for Chronic Anal Fissure:Protocol of A Multi-center Randomized Controlled trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Lateral Internal Sphincterotomy with Skin Grafting for Chronic Anal Fissure:Protocol of A Multi-center Randomized Controlled trial Wei Xie, Fandong Kong, Yongchang Zhao, Qiurui Cao, Hai He, Yulan Xian, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7013035/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 4 You are reading this latest preprint version Abstract Background: Anal fissure, a prevalent anorectal disorder, is defined as a longitudinal tear in the anoderm distal to the dentate line.Chronicity develops in a substantial fraction of anal fissures despite initial conservative success, resulting in significant quality-of-life deficits. Therapeutic efforts for these CAFes entail anal pressure reduction as a cornerstone, implemented through either nonsurgical agents or surgical procedures.Surgical intervention has historically constituted the primary approach chronic anal fissure-associated sphincter spasm, despite the absence of placebo-controlled trials to validate its efficacy.However surgical approaches take a long time to heal the wound. A multi-center randomized controlled trial is proposed to evaluate the efficacy of lateral internal sphincterotomy combined with surgical wound skin grafting in promoting anal fissure healing. Methods: It is is a multi-center, hospital-based, random controlled trial.This parallel-group, randomized controlled trial will be conducted at three hospitals. Eligible adult patients (n=104) with refractory anal fissures will undergo block randomization (block size=6) to the experimental or control group, ensuring equal group sizes.Lateral internal sphincterotomy with concurrent skin grafting will be performed in the experimental group, whereas lateral internal sphincterotomy alone will be administered to the control group.All surgical procedures will be conducted by attending colorectal surgeons or senior consultants. Efficacy and safety endpoints will be systematically monitored, documented, and statistically analyzed. Discussion: Lateral internal sphincterotomy demonstrates efficacy in resolving chronic anal fissures with low recurrence rates and an acceptable safety profile.Concurrently, autologous skin grafting accelerates wound epithelialization, potentially reducing healing duration in refractory chronic anal fissures. Trial registration: Chinese Clinical Trial Register, ID: ChiCTR2400079420. Registered on 3 January 2024. anal fissure lateral internal sphincterotomy randomized controlled trial skin grafting Full Text Supplementary Files SPIRITchecklist.docx Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 08 Jan, 2026 Reviewers invited by journal 15 Sep, 2025 Editor assigned by journal 10 Aug, 2025 First submitted to journal 17 Jul, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7013035","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":515319285,"identity":"7153a7d7-9746-4dee-bdc1-3d856128bb00","order_by":0,"name":"Wei Xie","email":"","orcid":"","institution":"Guangzhou Panyu Hexian Memorial Hopital","correspondingAuthor":false,"prefix":"","firstName":"Wei","middleName":"","lastName":"Xie","suffix":""},{"id":515319286,"identity":"7477da27-7e44-4fab-90bf-cd039fdf1f80","order_by":1,"name":"Fandong Kong","email":"","orcid":"","institution":"Guangzhou Panyu Hexian Memorial 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[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"anal fissure, lateral internal sphincterotomy, randomized controlled trial, skin grafting","lastPublishedDoi":"10.21203/rs.3.rs-7013035/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7013035/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e Anal fissure, a prevalent anorectal disorder, is defined as a longitudinal tear in the anoderm distal to the dentate line.Chronicity develops in a substantial fraction of anal fissures despite initial conservative success, resulting in significant quality-of-life deficits. Therapeutic efforts for these CAFes entail anal pressure reduction as a cornerstone, implemented through either nonsurgical agents or surgical procedures.Surgical intervention has historically constituted the primary approach chronic anal fissure-associated sphincter spasm, despite the absence of placebo-controlled trials to validate its efficacy.However surgical approaches\u0026nbsp;take a long time to heal the wound.\u0026nbsp;A multi-center randomized controlled trial is\u0026nbsp;proposed\u0026nbsp;to evaluate the efficacy of lateral internal sphincterotomy\u0026nbsp;combined with surgical wound skin grafting in promoting anal fissure healing.\u003cbr\u003e\n\u003cstrong\u003eMethods:\u003c/strong\u003e It is is a multi-center, hospital-based, random controlled trial.This\u0026nbsp;parallel-group, randomized controlled trial will be conducted at three\u0026nbsp;hospitals. Eligible adult patients (n=104) with refractory anal fissures will undergo block randomization (block size=6) to the experimental or control group, ensuring equal group sizes.Lateral internal sphincterotomy\u0026nbsp;with concurrent skin grafting will be performed in the experimental group, whereas lateral internal sphincterotomy\u0026nbsp;alone will be administered to the control group.All surgical procedures will be conducted by attending colorectal surgeons or senior consultants. Efficacy and safety endpoints will be systematically monitored, documented, and statistically analyzed.\u003cbr\u003e\n\u003cstrong\u003eDiscussion:\u003c/strong\u003e Lateral internal sphincterotomy demonstrates efficacy in resolving chronic anal fissures with low recurrence rates\u0026nbsp;and an acceptable safety profile.Concurrently, autologous skin grafting accelerates wound epithelialization, potentially reducing healing duration in refractory chronic anal fissures.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u003c/strong\u003e Chinese Clinical Trial Register, ID: ChiCTR2400079420. Registered on 3 January 2024.\u003c/p\u003e","manuscriptTitle":"Lateral Internal Sphincterotomy with Skin Grafting for Chronic Anal Fissure:Protocol of A Multi-center Randomized Controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-23 06:18:25","doi":"10.21203/rs.3.rs-7013035/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2026-01-08T07:46:55+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-09-15T12:43:58+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-08-10T05:24:35+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-07-17T11:51:33+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"
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