Recruiting nowPhase 4Randomised
| Registry number | NCT07209787 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 4 |
| Design | randomised, open label |
| Taking part | 966 people (planned) |
| Who can join | up to age 85 Years |
| Run by | Beijing Chao Yang Hospital |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Device SIS-reinforced anastomosis
What it is measuring
Rate of anastomotic leak within 30 days post-surgery
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
What this trial is trying to do
The researchers are testing whether placing a sheet of small intestinal submucosa (SIS), a biological reinforcing material, around the surgically joined ends of the bowel helps the connection heal more securely after rectal cancer surgery. The comparison is SIS reinforcement versus the usual connection without reinforcement.
The idea is that stronger healing could reduce anastomotic leakage, when the bowel join breaks down, compared with standard surgery. The main measure is leakage within 30 days; the trial will also assess whether fewer patients need a temporary stoma, as well as complications and quality of life.
Worth knowing: This is a multicentre randomised trial measuring surgical complications and stoma status, not cancer survival or control of the cancer itself.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
Phase 4. Studies a treatment already approved and in use, usually for longer-term effects.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria–
1. Age ≤ 85 years old, regardless of gender.
2. 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.
3. 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.
4.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07209787, registered by Beijing Chao Yang Hospital on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.