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Clinical Trial NCT07209787 for Rectal Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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SIS-Reinforced vs. Conventional Anastomosis for Mid-to-Low Rectal Cancer: A Multicenter RCT on Anastomotic Leak Phase 4 966
Clinical Trial NCT07209787 is designed to study Treatment for Rectal Cancer. It is a Phase 4 interventional study that is recruiting, having started on 11 September 2025, with plans to enroll 966 participants. Led by Beijing Chao Yang Hospital, it is expected to complete by 31 August 2027. The latest data from ClinicalTrials.gov was last updated on 13 March 2026.
Brief Summary
The goal of this clinical trial is to learn whether using a reinforcing material called SIS (small intestinal submucosa) during bowel connection after rectal cancer surgery can help prevent anastomotic leakage-a serious complication where the connection between two parts of the intestine fails to heal properly. This study will focus on patients with mid-to-low rectal cancer who are scheduled for surgery.
The main qu...
Show MoreOfficial Title
A Prospective, Multicenter, Randomized Controlled Study Comparing Effect of Conventional Versus SIS-Reinforced Rectum Anastomosis On Anastomotic Leak Following Radical Resection of Mid-to-Low Rectal Cancer（SISReal）
Conditions
Rectal CancerOther Study IDs
- 2025-科-689
NCT ID Number
Start Date (Actual)
2025-09-11
Last Update Posted
2026-03-13
Completion Date (Estimated)
2027-08-31
Enrollment (Estimated)
966
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalIntervention arm | SIS-reinforced anastomosis This intervention uses a porcine small intestinal submucosa (SIS) reinforcement patch during rectal anastomosis. The sterile, biologic, acellular mesh is mounted onto the stapler anvil and cartridge. When fired, it encircles and externally reinforces the staple line. This provides immediate mechanical support and promotes healing by serving as a scaffold for tissue integration. It is a single-use, resorbable material...Show More |
No Interventioncontrol group | N/A |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Rate of anastomotic leak within 30 days post-surgery | Proportion of participants with an anastomotic leak (AL) within 30 days post-surgery. AL is a defect in the intestinal wall anastomosis, confirmed by clinical signs (e.g., fever, fecal drain output), imaging (CT scan with contrast extravasation or peri-anastomotic collections), or endoscopy. Leaks are graded per International Study Group of Rectal Cancer (ISREC) criteria: Grade A (no intervention), B (managed without reoperation), or C (requires reoperation). | From the date of surgery up to 30 days postoperatively |
Rate of anastomotic leak within 30 days post-surgery | The proportion of participants experiencing an anastomotic leak (AL) within 30 days after surgery. AL is defined as a defect in the integrity of the intestinal wall at the anastomosis site, leading to communication between the intra- and extraluminal compartments. Diagnosis is based on a combination of clinical signs (e.g., fever, abdominal pain, fecal discharge from drain), imaging findings (extravasation of contrast on enema CT scan or presence of peri-anastomotic fluid/air collections), or endoscopic evidence. Leaks are graded per the International Study Group of Rectal Cancer (ISREC) classification: Grade A (requiring no active therapeutic intervention), Grade B (requiring active therapeutic intervention but manageable without reoperation), and Grade C (requiring reoperation). | From the date of surgery up to 30 days postoperatively. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
- Age ≤ 85 years old, regardless of gender.
- Patients with mid - low rectal cancer, where the lower edge of the cancer focus is ≤ 10 cm from the anus and who can undergo rectal anastomosis with a circular stapler (including mid - low and some ultra - low rectal anastomoses). This includes patients after neoadjuvant therapy, patients with insufficient function of important organs such as the heart, liver, and kidneys who can tolerate surgery, and patients after intestinal obstruction stent placement or chemotherapy after intestinal obstruction stent placement.
- For patients who, after being fully informed by doctors, still clearly refuse neoadjuvant therapy (for advanced rectal cancer) and/or immunotherapy (for MSI - H/dMMR rectal cancer) and request direct surgery, they are generally not included in this study. If a patient insists on enrolling, the operating surgeon must have a second conversation with the patient and/or their family members, and sign in the medical record to confirm the following: The patient is aware of the existence of the neoadjuvant therapy/immunotherapy pathway but refuses the relevant treatment and insists on direct surgery. Only in this case can the patient be allowed to enroll.
- Patients who received conversion therapy due to distant organ (such as liver, lung) metastasis before surgery and then underwent surgery with primary anastomosis can be included in this study. If organ metastasis is accidentally found during surgery, or if the small intestine or bladder in the pelvic floor is invaded, but the surgeon believes it does not affect rectal anastomosis, the patient does not need to withdraw from the study.
- The patient or their authorized representative voluntarily signs the informed consent form and can cooperate to complete the follow - up during the trial.
- Patients who, through examination and pre - operative consultation, cannot tolerate routine surgery.
- Patients who are currently participating in other clinical studies.
- Since the test device (SIS reinforcement patch) is derived from porcine - sourced materials, out of respect for specific religious beliefs (such as Islam), we do not recommend that subjects whose beliefs prohibit contact with porcine - sourced products participate in this study. We will fully communicate this situation with all potential subjects, and the subjects will make their own decisions based on their personal beliefs and cultural backgrounds.
- Patients who do not meet the NCCN and the National Health Commission of China's treatment standards for rectal cancer will not be included in this study. For example, patients who should receive neoadjuvant therapy before surgery should preferentially choose neoadjuvant therapy, and MSI - H/dMMR patients are required to undergo immunotherapy first.
- Due to the possible difficulty in matching the number of patients/omissions with regular patients, patients who require lateral lymph node dissection and those who receive Ta - TME will not be included in this study.
- Patients who, due to language or intellectual disabilities, cannot understand the content of the trial protocol, cannot complete the follow - up, or for whom the researcher deems there are other situations that are not suitable for enrollment (such as uncontrolled severe underlying diseases, mental illness, etc.).
Beijing Chao Yang Hospital- 🏥Beijing Hospital
Study Central Contact
Contact: Chunxiang Ye, +86-010-85231604, [email protected]
1 Study Locations in 1 Countries
Beijing Municipality
Beijing chaoyang hospital, Beijing, Beijing Municipality, 100000, China
Chunxiang Ye, Contact, +86-010-85231604, [email protected]
Recruiting