Rectal CancerPhase 4NCT07209787
SIS-Reinforced vs. Conventional Anastomosis for Mid-to-Low Rectal Cancer: A Multicenter RCT on Anastomotic Leak
A Phase 4 study testing SIS-reinforced anastomosis in people with Rectal Cancer, run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- SIS-reinforced anastomosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 966 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2025to 31 Aug 2027
- Phase
- Phase 4
- 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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing chaoyang hospital
Beijing, Beijing Municipality, 100000
Chunxiang Ye, +86-010-85231604, chunxiang-ye@163.com
About this study
Official 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）
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 questions the study aims to answer are:
Read more
Does using an SIS-reinforced connection reduce the rate of anastomotic leakage within 30 days after surgery compared to standard connection methods?
Does it also reduce the need for a temporary stoma (an opening in the abdomen for waste removal)?
Researchers will compare two groups:
Intervention group: Patients who receive the SIS-reinforced connection during surgery.
Control group: Patients who receive the standard connection without reinforcement.
Participants in this study will:
Be randomly assigned to either the intervention or control group.
Undergo standard laparoscopic or robot-assisted rectal cancer surgery.
Be followed up at 30 days, 90 days, and 12 months after surgery to check for complications, stoma status, and quality of life.
This study is being conducted across multiple hospitals in China to ensure the results are reliable and widely applicable.
- Conditions
- Rectal Cancer
- Being tested
- SIS-reinforced anastomosis
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIS-reinforced anastomosisDevice
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 intended to reduce anastomotic leakage by improving seal integrity, distinguishing it from standard unreinforced stapling or other synthetic/biologic grafts.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Device: SIS-reinforced anastomosis |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: From the date of surgery up to 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start21 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 966 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Huashan Hospital, First Affiliated Hospital of Gannan Medical University, Guangdong Second Provincial General Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, First Affiliated Hospital of Harbin Medical University, Changhai Hospital, Henan Provincial People's Hospital, Hubei Cancer Hospital, Hunan Provincial People's Hospital, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Second Hospital of Jilin University, Jiangxi Provincial People's Hopital, LanZhou University, The First Affiliated Hospital of Nanchang University, The Affiliated Jiangning Hospital of Nanjing Medical University, The First Affiliated Hospital of BaoTou Medical College, The Affiliated Hospital of Qingdao University, Qilu Hospital of Shandong University, Northern Jiangsu People's Hospital, Suzhou Municipal Hospital, Jiangsu Taizhou People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Zhongnan Hospital, The Third Xiangya Hospital of Central South University, First Affiliated Hospital of Xinjiang Medical University, Yunnan Cancer Hospital, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Zhengzhou University, PLA Rocket Force Characteristic Medical Center, The General Hospital of Western Theater Command, China-Japan Friendship Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, The Second Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Chongqing Medical University, Zhoukou Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209787
- Sponsor's protocol ID
- 2025-科-689
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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）
- ClinicalTrials.gov ID
- NCT07209787
- Acronym / sponsor ID
- 2025-科-689
- Conditions
- Rectal Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 966 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital, Huashan Hospital, First Affiliated Hospital of Gannan Medical University, Guangdong Second Provincial General Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, First Affiliated Hospital of Harbin Medical University, Changhai Hospital, Henan Provincial People's Hospital, Hubei Cancer Hospital, Hunan Provincial People's Hospital, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Second Hospital of Jilin University, Jiangxi Provincial People's Hopital, LanZhou University, The First Affiliated Hospital of Nanchang University, The Affiliated Jiangning Hospital of Nanjing Medical University, The First Affiliated Hospital of BaoTou Medical College, The Affiliated Hospital of Qingdao University, Qilu Hospital of Shandong University, Northern Jiangsu People's Hospital, Suzhou Municipal Hospital, Jiangsu Taizhou People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Zhongnan Hospital, The Third Xiangya Hospital of Central South University, First Affiliated Hospital of Xinjiang Medical University, Yunnan Cancer Hospital, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Zhengzhou University, PLA Rocket Force Characteristic Medical Center, The General Hospital of Western Theater Command, China-Japan Friendship Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, The Second Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Chongqing Medical University, Zhoukou Central Hospital
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Oct 2025 (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.
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 questions the study aims to answer are:
Does using an SIS-reinforced connection reduce the rate of anastomotic leakage within 30 days after surgery compared to standard connection methods?
Does it also reduce the need for a temporary stoma (an opening in the abdomen for waste removal)?
Researchers will compare two groups:
Intervention group: Patients who receive the SIS-reinforced connection during surgery.
Control group: Patients who receive the standard connection without reinforcement.
Participants in this study will:
Be randomly assigned to either the intervention or control group.
Undergo standard laparoscopic or robot-assisted rectal cancer surgery.
Be followed up at 30 days, 90 days, and 12 months after surgery to check for complications, stoma status, and quality of life.
This study is being conducted across multiple hospitals in China to ensure the results are reliable and widely applicable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: SIS-reinforced anastomosis |
| control group | No intervention | – |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| SIS-reinforced anastomosisThis 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 intended to reduce anastomotic leakage by improving seal integrity, distinguishing it from standard unreinforced stapling or other synthetic/biologic grafts. | Device | Intervention arm |
Primary outcome
Rate of anastomotic leak within 30 days post-surgery
Time frame: From the date of surgery up to 30 days postoperatively
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).
Rate of anastomotic leak within 30 days post-surgery
Time frame: From the date of surgery up to 30 days postoperatively.
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).
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 17 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SIS-reinforced anastomosis in people with Rectal Cancer, run by Beijing Chao Yang Hospital at 1 site in China.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chunxiang Ye (+86-010-85231604, chunxiang-ye@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of anastomotic leak within 30 days post-surgery (time frame: From the date of surgery up to 30 days postoperatively). The study lists 2 primary outcomes in all. 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 17 Jun 2026.