Preoperative Nasal Intestinal Obstruction Catheter Mediated Terminal Ileum Fecal Diversion Versus Intraoperative Protective Ileostomy for Preventing Anastomotic Leakage After Mid Low Rectal Cancer Surgery: A Non Inferiority, Prospective, Multicenter Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yifei Pan, MD
- Phone Number: 86+13506641535
- Email: 13506641535@139.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
I01. Aged ≥18 years, capable of understanding the study and providing written informed consent.
I02. Rectal adenocarcinoma confirmed by colonoscopic biopsy.
I03. The distal margin of the tumor is ≤5 cm from the anal verge as assessed by pelvic MRI, digital rectal examination and/or endoscopy; this cutoff may be extended to ≤7 cm for male patients and/or those with BMI ≥28 kg/m².
I04. Treatment pathway is consistent with current guidelines and confirmed in writing by the multidisciplinary team (MDT):
Patients proceeding directly to surgery without neoadjuvant therapy must be cT1-2N0, or low-risk cT3a/bN0 on pelvic MRI, with the mesorectal fascia (MRF) ≥2 mm from the tumor, negative MRI-detected extramural venous invasion (mrEMVI), no suspicious lateral lymph nodes, and no levator ani muscle/sphincter involvement.
Patients who have previously received neoadjuvant systemic chemotherapy without pelvic radiotherapy in accordance with guidelines may be enrolled; such treatment decision must have been made prior to study recruitment, and the MDT shall document in writing the rationale for proceeding directly to surgery[29,30].
I05. Planned open, laparoscopic or robot-assisted Dixon operation with primary anastomosis.
I06. The attending physician judges, prior to randomization, that protective fecal diversion is indicated per current clinical practice.
I07. Eastern Cooperative Oncology Group (ECOG) performance status 0-2; organ function and coagulation status are tolerable for the planned surgery.
I08. Willingness to undergo randomization, scheduled anastomotic assessment, and a minimum of 6-month follow-up.
Exclusion Criteria:
E01. Emergency surgery, or presence of complete bowel obstruction requiring urgent management, bowel perforation, or uncontrolled gastrointestinal bleeding.
E02. Prior pelvic radiotherapy; or high-risk features that mandate neoadjuvant therapy per current guidelines in patients without neoadjuvant treatment, including cT3c/d, cT4, N2, threatened/positive MRF, positive mrEMVI, suspicious lateral lymph nodes, or levator ani muscle/sphincter involvement; or intended to bypass indicated neoadjuvant therapy for the purpose of participating in this study.
E03. Imaging or preoperative assessment indicating primary anastomosis is not feasible; planned Miles operation, Hartmann procedure, or total colectomy/proctectomy.
E04. Clinical M1 disease, or other conditions requiring major concurrent surgery that substantially alters perioperative risk.
E05. Prior esophageal, gastric or complex abdominal surgery, severe adhesions, upper gastrointestinal stricture, or other conditions rendering transnasal long-tube placement unacceptably risky.
E06. Severe nasal/nasopharyngeal disease, risk of skull base fracture, active upper gastrointestinal bleeding, or other contraindications to transnasal intubation.
E07. Uncorrected severe cardiac, pulmonary, hepatic, renal insufficiency or coagulopathy.
E08. Pregnancy or lactation; women of child-bearing potential unable to complete pregnancy exclusion as clinically required.
E09. Known severe allergy to catheter materials or planned contrast agents with no acceptable alternative.
E10. Severe psychiatric, cognitive or communication impairment without legal representative available, precluding understanding of the study or compliance with key safety measures.
E11. Participation in another interventional study within 30 days prior to screening that may confound study endpoints.
E12. Investigator judges the subject unsuitable for inclusion for specific safety reasons, with documentation in the screening record.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Protective Loop Ileostomy
Preoperative oral placement of bowel obstruction catheter： Preoperatively, the stoma therapist or trained personnel comprehensively assess and mark the abdominal wall in standing, sitting and supine positions.
After completion of TME and anastomosis inspection, select a well-perfused, tension-free terminal ileal loop at an appropriate distance from the ileocecal valve.
Deliver the loop through the pre-marked abdominal wall tract, avoiding torsion and mesenteric compression.
Re-confirm proximal-distal orientation if necessary.
Create a loop ileostomy per the unified study SOP and locally-approved institutional procedures; verify mucosal color, bleeding and patency.
Document stoma height, diameter, location and intraoperative abnormalities.
Apply an appropriate stoma baseplate and pouch post-operatively, and provide education on skin care, fluid-electrolyte management and self-care.
|
|
|
Active Comparator: Protective Diversion with Bowel Obstruction Catheter
Participants are placed in semi-recumbent position for identity and vital-sign checks.
A patent nostril is chosen with routine local lubrication and topical anesthesia.
The catheter is gently advanced nasally with patient swallowing, no routine endoscopy.
Secured per product instructions and study SOP after gastric entry, it advances distally via balloon traction and peristalsis; forceful advancement is forbidden with marked resistance.
Qualified physicians may use endoscopy only for repeated pyloric failure, anatomical anomalies, catheter coiling or high injury risk, documenting all relevant details.
The distal balloon is inflated per validated product labeling; 10-15 mL is used only if label-compliant, and off-label use is prohibited.
Remove the endoscope, fix the external catheter with adequate slack, and record nasal scale, fixation and participant tolerance.
Apply drainage/decompression with minimal effective negative pressure, document settings and avoid unvalidated high suction
|
Participants 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Anastomotic Failure
Time Frame: within 90±14 days after primary surgery,
|
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.
|
within 90±14 days after primary surgery,
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KY-2026-436
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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