We are currently conducting a multicenter randomized controlled clinical trial entitled \*Preoperative Nasal Placement of Bowel Obstruction Catheter for Terminal Ileum Fecal Diversion versus Intraoperative Protective Ileostomy in Preventing Anastomotic Leakage After Surgery for Mid-low Rectal Cancer\*. The study will be performed at 5-10 hospitals, with an anticipated enrollment of approximately 500 participants. The First Affiliated Hospital of Wenzhou Medical University serves as the lead institution, and participating centers will enroll subjects on a competitive basis.
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Preoperative oral placement of bowel obstruction catheter
Procedure/SurgeryParticipants are placed in semi-recumbent position for identity verification and vital sign assessment; a patent nasal passage is selected, with local lubrication and topical anesthesia administered per routine clinical practice. The catheter is gently advanced via the nasal route with the participant's swallowing, without routine endoscopic assistance. After entering the gastric cavity, the catheter is secured per product instructions and study SOP, and advanced distally by balloon traction and natural peristalsis; forcible advancement is strictly prohibited upon significant resistance. Endoscopic assistance may be performed by qualified physicians only after repeated failed pyloric passage, anatomical abnormalities, catheter coiling or elevated injury risk, with documentation of indication, start time, endoscopic findings, outcomes and related adverse events.
Rate of Anastomotic Failure
Rate of persistent anastomotic non-healing / anastomotic failure (all grades) within 90±14 days after primary surgery, including objective non-healing at the fixed time-point and pre-specified fistula-related rescue failure events occurring before day 90.
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