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| Name | Class |
|---|---|
| Hospital San Rafael de Facatativá | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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/electrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded) |
|
| 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/electrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transverse Mucosal Incision During POEM | 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/electrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Effective Submucosal Tunnel Entry (Seconds) | Time (in seconds) from the first mucosal cut to effective entry of the endoscope cap into the submucosal tunnel, defined as allowing advancement of at least 1 cm. | During the POEM procedure (Day 0; intraoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Requiring Hemostasis With Coagrasper® | Proportion of procedures with bleeding that requires hemostasis using Coagrasper® (Yes/No). | During the POEM procedure (Day 0; intraoperative) |
| Procedure-Related Complications (Up to 30 Days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan P Alzate, MD, MsC | Contact | +573102587912 | jpalzategr@unal.edu.co |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alzate | Bogotá | Colombia |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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Operator blinding is not feasible due to the nature of the techniques. Participants will remain masked. The primary outcome time will be extracted objectively using automatic timestamps/logs and assessed by masked evaluators; statistical analyses will be performed using masked group labels (A/B). Individual unmasking will be limited to clinical circumstances requiring it.
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| Longitudinal Mucosal Incision During POEM | Procedure | 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/electrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded). |
|
Any complication related to the procedure, monitored through 30 days.
| Up to 30 days after the procedure (contacts at ~1 week and Day 30; plus early assessment Days 1-2). |
| D004066 | Digestive System Diseases |