Transverse vs Longitudinal Mucosal Incision During POEM

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.

This 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/major esophageal surgery, uncorrectable coagulopathy, pregnancy, active systemic infection, anesthesia contraindication, or anticipated technical inability to perform POEM.

All 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.

The 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.

Participants complete a screening/preoperative visit (up to 30 days before), undergo the POEM procedure, have early in-hospital/discharge assessment (days 1-2), and receive safety follow-up contacts at approximately 1 week and day 30.

Risks 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.

The study will be conducted with written informed consent, confidentiality protections (pseudonymization and secure storage), and reporting of results in aggregate form.