Rectal Cancer PatientsNCT07821437
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
A study testing Preoperative oral placement of bowel obstruction catheter in people with Rectal Cancer Patients, run by First Affiliated Hospital of Wenzhou Medical University.
Trial summary
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*. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer Patients
- What is being tested?
- Preoperative oral placement of bowel obstruction catheter
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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].
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Rectal Cancer Patients
- Being tested
- Preoperative oral placement of bowel obstruction catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative oral placement of bowel obstruction catheterProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Protective Loop Ileostomy | No intervention | 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. |
| Protective Diversion with Bowel Obstruction Catheter | Active comparator | 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 Receives: Procedure: Preoperative oral placement of bowel obstruction catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 90±14 days after primary surgery,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer PatientsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Yifei, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821437
- Sponsor's protocol ID
- KY-2026-436
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data, the data dictionary, study protocol, CRF, and statistical analysis plan will be available upon reasonable request within six months after study completion and database lock, for a period of five years. Applicants must submit a research proposal and relevant ethics documents, obtain approval from the principal investigator and coordinating institution, and sign a data use agreement. Identifiable information will not be shared. Contact: Dr. Yifei Pan, +86 135 0664 1535.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07821437
- Acronym / sponsor ID
- KY-2026-436
- Conditions
- Rectal Cancer Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protective Loop Ileostomy | No intervention | –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. |
| Protective Diversion with Bowel Obstruction Catheter | Active comparator | Procedure: Preoperative oral placement of bowel obstruction catheterParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative oral placement of bowel obstruction catheterParticipants 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. | Procedure or surgery | Protective Diversion with Bowel Obstruction Catheter |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data, the data dictionary, study protocol, CRF, and statistical analysis plan will be available upon reasonable request within six months after study completion and database lock, for a period of five years. Applicants must submit a research proposal and relevant ethics documents, obtain approval from the principal investigator and coordinating institution, and sign a data use agreement. Identifiable information will not be shared. Contact: Dr. Yifei Pan, +86 135 0664 1535.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative oral placement of bowel obstruction catheter in people with Rectal Cancer Patients, run by First Affiliated Hospital of Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifei Pan, MD (86+13506641535, 13506641535@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Anastomotic Failure (time frame: within 90±14 days after primary surgery,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.