[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spastic-esophageal-motility-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spastic-esophageal-motility-disorders":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"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":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Esophageal Achalasia","Spastic Esophageal Motility Disorders","NOT_YET_RECRUITING","2026-02-20",{"date":31,"type":32},"2026-02-24","ACTUAL",{"date":34,"type":20},"2026-02-22",{"date":36,"type":20},"2026-08-02",{"name":38,"class":39},"Universidad Nacional de Colombia","OTHER"]