[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625695":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":25,"overallStatus":78,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Universidad Nacional de Colombia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transverse Mucosal Incision During POEM","EXPERIMENTAL","POEM performed with a 15 mm transverse mucosal incision (perpendicular to the esophageal axis) for entry into the submucosal tunnel, under a standardized POEM protocol (general anesthesia with orotracheal intubation, CO₂ insufflation, validated endoscopic knives\u002Felectrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded)",[13],"Procedure: Transverse Mucosal Incision During POEM",{"label":15,"type":16,"description":17,"interventionNames":18},"Longitudinal Mucosal Incision During POEM","ACTIVE_COMPARATOR","POEM performed with a 15 mm longitudinal mucosal incision (parallel to the esophageal axis) for entry into the submucosal tunnel, under the same standardized POEM protocol (general anesthesia with orotracheal intubation, CO₂ insufflation, validated endoscopic knives\u002Felectrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded)",[19],"Procedure: Longitudinal Mucosal Incision During POEM",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","POEM performed with a 15 mm transverse mucosal incision (perpendicular to the esophageal axis) for entry into the submucosal tunnel, under a standardized POEM protocol (general anesthesia with orotracheal intubation, CO₂ insufflation, validated endoscopic knives\u002Felectrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded).",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"POEM performed with a 15 mm longitudinal mucosal incision (parallel to the esophageal axis) for entry into the submucosal tunnel, under the same standardized POEM protocol (general anesthesia with orotracheal intubation, CO₂ insufflation, validated endoscopic knives\u002Felectrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded).",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Juan P Alzate, MD, MsC","CONTACT","+573102587912","jpalzategr@unal.edu.co",[36],{"facility":37,"status":25,"city":38,"state":25,"zip":25,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Alzate","Bogotá","Colombia","CO",{"type":42,"coordinates":43},"Point",[44,45],-74.08175,4.60971,{"lat":45,"lon":44},[48],{"name":49,"role":32,"phone":33,"phoneExt":25,"email":50},"Juan P Alzate","jpag6@hotmail.com",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Juan Pablo Alzate","Clinical research institute investigator",[56],{"name":57,"class":58},"Hospital San Rafael de Facatativá","UNKNOWN","100625695","phase-3-transverse-vs-longitudinal-mucosal-incision-during-poem-100625695",false,"NCT07425977","Transverse vs Longitudinal Mucosal Incision During POEM","Transverse Versus Longitudinal Mucosal Incision in Peroral Endoscopic Myotomy: A Multicenter Randomized Clinical Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of achalasia or other spastic esophageal motility disorders with an indication for POEM\n* ASA physical status I-III\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Prior myotomy or major esophageal surgery\n* Uncorrectable coagulopathy\n* Pregnancy\n* Active systemic infection\n* Contraindication to anesthesia\n* Any situation predicting technical inability to perform POEM","ALL","18 Years",{"count":69,"type":70},140,"ESTIMATED","INTERVENTIONAL",[73],"PHASE3","Peroral endoscopic myotomy (POEM) is a minimally invasive endoscopic procedure used to treat achalasia and other spastic esophageal motility disorders. A key step in POEM is creating a small opening in the esophageal lining (mucosal incision) to enter the submucosal tunnel. This study evaluates whether making that entry incision \\*\\*transverse\\*\\* (across the esophagus) versus \\*\\*longitudinal\\*\\* (along the esophagus) improves procedural efficiency without reducing safety.\n\nThis is a \\*\\*multicenter, randomized (1:1), parallel-group clinical trial\\*\\* conducted in three therapeutic endoscopy units in Colombia (Hospital Universitario del Valle and Clínica Versalles in Cali, and Clínica del Occidente in Bogotá). Adults (≥18 years) with an indication for POEM, ASA I-III, and ability to provide informed consent will be eligible; key exclusions include prior myotomy\u002Fmajor esophageal surgery, uncorrectable coagulopathy, pregnancy, active systemic infection, anesthesia contraindication, or anticipated technical inability to perform POEM.\n\nAll procedures are standardized: POEM under \\*\\*general anesthesia with orotracheal intubation\\*\\*, \\*\\*CO₂ insufflation\\*\\*, validated endoscopic knives and preset electrosurgical modes; hemostasis with \\*\\*Coagrasper® only if needed\\*\\*; and closure using standard \\*\\*through-the-scope (TTS) clips\\*\\*. Participants are randomly assigned to a \\*\\*15 mm transverse mucosal incision\\*\\* (perpendicular to the esophageal axis) or a \\*\\*15 mm longitudinal mucosal incision\\*\\*. Full-procedure video is recorded for quality control and to allow objective timing, with blinded assessment of the primary outcome.\n\nThe \\*\\*primary outcome\\*\\* is the time (seconds) from the first mucosal cut to successful entry of the endoscope cap into the submucosal tunnel (advancing at least 1 cm). \\*\\*Secondary outcomes\\*\\* include need for hemostasis with Coagrasper®, number of clips required for complete closure, and early complications (including perforation and gas-related events such as capnoperitoneum requiring decompression and emphysema), monitored through \\*\\*30 days\\*\\*.\n\nParticipants complete a screening\u002Fpreoperative visit (up to 30 days before), undergo the POEM procedure, have early in-hospital\u002Fdischarge assessment (days 1-2), and receive safety follow-up contacts at approximately 1 week and day 30.\n\nRisks are those expected from standard POEM and peri-anesthesia care (e.g., bleeding, perforation, infection, and gas-related complications), and participants may not directly benefit clinically. However, the transverse incision may shorten access and closure time and reduce resource use without increasing short-term complications.\n\nThe study will be conducted with written informed consent, confidentiality protections (pseudonymization and secure storage), and reporting of results in aggregate form.",[76,77],"Esophageal Achalasia","Spastic Esophageal Motility Disorders","NOT_YET_RECRUITING","2026-02-20",{"date":81,"type":82},"2026-02-24","ACTUAL",{"date":84,"type":70},"2026-02-22",{"date":86,"type":70},"2026-08-02",{"name":5,"class":6},1]