An interventional study of SIS Patch Intervention for High - Risk Colorectal Anastomosis in Colorectal Cancer, sponsored by Beijing Chao Yang Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Beijing Chao Yang Hospital · Not applicable, Interventional, and Treatment
Among 1,134 studies in Colorectal Neoplasms with a site in China — 526 open to participants now, 603 under way, 67 of them phase 3. Colorectal Neoplasms · China.
Among the 1,134 studies in Colorectal Neoplasms with a site in China, this one is the 197th largest by planned enrollment of the 889 interventional ones that give a count, is one of 125 that started in 2025, is one of 150 with no phase, reaches primary completion later than 390 of the 602 other live ones, and was the 1,082nd registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
Browse Colorectal Neoplasms studies →526 of the 1,134 studies in Colorectal Neoplasms with a site in China are open now. Recruiting first, the newest first:
Fudan University · Sites in China
Ages 18–75
Fudan University · Sites in China
Ages 18+
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–80 · Healthy volunteers
Shanghai EpimAb Biotherapeutics Co., Ltd. · Sites in China
Ages 18–74
Nanjing Leads Biolabs Co.,Ltd · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,134 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 224 · Phase 2 465 · Phase 3 147 · Phase 4 21
First in 1993; this study’s year is marked. 125 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 255 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 80 across the 889 interventional studies, 400 across the 243 observational. Of the 213 that completed or were terminated, 27 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
247 of 1,134 have an industry lead sponsor. The 10 most frequent:
Beijing Chao Yang Hospital is the lead sponsor of 142 studies on the registry; 51 are open to participants now.
Beijing Chao Yang Hospital has 4 studies filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
142 of the studies in Colorectal Neoplasms with a site in China that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06008119Phase 3Shanghai Kechow Pharma, Inc.Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer | 2026-12-24 |
| NCT05171660Phase 3Second Affiliated Hospital, School of Medicine, Zhejiang UniversityCombination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer | 2026-12-30 |
| NCT03303495Phase 3Sun Yat-sen UniversityA Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC | 2026-12-31 |
| NCT06280495Phase 3Sun Yat-sen UniversityNeoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients | 2026-12-31 |
| NCT05086614Phase 3Fudan UniversityThymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer | 2027-03-31 |
Add all 142 to your calendar (.ics) → With an account.
Among the 1,134 studies in Colorectal Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to evaluate the safety and effectiveness of Small Intestinal Submucosa (SIS) material used for anastomotic reinforcement in patients with high-risk factors for colorectal cancer to prevent anastomotic leakage. It will also explore the molecular biological mechanism of SIS/polycaprolactone-acrylic acid (PCA) patches in promoting tissue regeneration and verify the biological versatility of the new SIS/PCA patches at the cellular level. The main questions it aims to answer is:
Can the use of SIS reinforcement patches effectively reduce the incidence of anastomotic leakage in patients with high-risk colorectal anastomosis after surgery (within 1 month, 3 months, and 6 months of follow-up)? This is a single-arm, non-randomized, open-label, multi-center exploratory study. All eligible patients will be in the intervention group and receive SIS reinforcement patch for anastomosis during surgery; there is no control group for comparison.
Participants will:
Sign an informed consent form during the screening period (7 days before surgery) and provide basic clinical information, medical history, and undergo assessment against inclusion and exclusion criteria.
Undergo gastrointestinal anastomosis using SIS reinforcement patches during surgery (Day 0 of the study), with intraoperative observation of the immediate stapling effect and recording of anastomotic conditions and complications.
Complete follow-up visits at approximately 30 days, 90 days, and 180 days after surgery. During follow-up, they will undergo assessments of anastomotic leakage, healing status, adverse events, and effectiveness; they will also cooperate with the recording of concomitant medications/implanted devices and filling out of Case Report Forms (CRFs).
Have their relevant perioperative indicators collected by researchers to evaluate the safety and effectiveness of the SIS material anastomotic reinforcement patch.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must meet all the following criteria to be enrolled in this trial:
Determined by the researcher to have the following high-risk factors for anastomotic leakage (i.e., high-risk anastomosis):
Exclusion Criteria:
Patients who meet any of the following exclusion criteria shall not be enrolled in this trial:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: SIS Patch Intervention for High - Risk Colorectal Anastomosis
This intervention uses a Small Intestinal Submucosa (SIS) patch (a medical device) to reinforce anastomosis during gastrointestinal anastomosis surgery, targeting patients with high-risk factors for colorectal anastomotic leakage. Preoperatively, subjects are screened for high-risk factors (e.g., abdominopelvic abscess from gastrointestinal perforation, ulcerative colitis history, hormone therapy within 6 months, etc.). On Study Day 0 (surgery day), the SIS patch is applied during colorectal anastomosis, with intraoperative observation of immediate stapling effect (e.g., seromuscular dehiscence, bleeding). Postoperatively, subjects are followed up at 1, 3, 6 months to monitor anastomotic leakage, healing and adverse events. It differs from conventional anastomosis by focusing on high-risk populations, with intraoperative and long-term assessments to prevent anastomotic leakage.
Intraoperative Anastomotic Immediate Defect Rate
During colorectal anastomosis with SIS patch reinforcement, the immediate stapling effect is assessed intraoperatively, including seromuscular dehiscence, incomplete anastomotic closure, bleeding at the serosal surface, intestinal wall, staple angles, and intraluminal mucosal surface, and whether additional serosal suturing is required. An "immediate defect" is defined as the presence of any of the above. Reported as the percentage of participants with an immediate defect.
Time frame: Surgery day (intraoperative)
30-Day Anastomotic Leakage Rate
Incidence of anastomotic leakage within 30 days after surgery. Anastomotic leakage is defined as leakage of intestinal contents through an anastomotic defect (including the suture line of a reconstructed rectal reservoir such as a J-pouch), confirmed by clinical symptoms, imaging, or surgical exploration, and graded as Clavien-Dindo Grade A, B, or C. Reported as the percentage of participants with anastomotic leakage.
Time frame: 30 days post-surgery (Visit 2)
90-Day Anastomotic Leakage Rate
Incidence of anastomotic leakage at 90 days after surgery. Leakage defined as in \[2\] (Clavien-Dindo Grade A/B/C). Reported as the percentage of participants with anastomotic leakage.
Time frame: 90 days post-surgery (Visit 3)
180-Day Anastomotic Leakage Rate
Incidence of anastomotic leakage at 180 days after surgery. Leakage defined as in \[2\] (Clavien-Dindo Grade A/B/C). Reported as the percentage of participants with anastomotic leakage.
Time frame: 180 days post-surgery (Visit 4)
Anastomotic Healing Rate
Proportion of anastomoses achieving complete epithelialization with no signs of leakage or inflammation, assessed at each follow-up visit. Reported as the percentage of participants with a healed anastomosis.
Time frame: 30, 90, and 180 days post-surgery
Wound Healing Defect Rate
Assessment of anastomotic wound healing defect rate based on wound healing classification at each follow-up visit. Reported as the percentage of participants with a wound healing defect.
Time frame: 30, 90, and 180 days post-surgery
Postoperative Infection Rate
Incidence of postoperative infection, including surgical site infection. Reported as the percentage of participants with infection.
Time frame: 30, 90, and 180 days post-surgery
Time to Perianastomotic Drain Removal
Time from surgery to removal of the perianastomotic drain. Reported in days.
Time frame: From surgery to drain removal (assessed by 30 days)
Time to Resumption of Oral Intake
Time from surgery to resumption of oral intake. Reported in days.
Time frame: From surgery to oral intake (assessed by 30 days)
Additional Treatments for Anastomotic Leakage
Incidence and nature of additional treatments required due to anastomotic leakage, including antibiotic use (and duration), fasting period, irrigation and drainage, endoscopic treatment, and reoperation/interventional procedures (with time). Reported as the percentage of participants receiving any such treatment.
Time frame: 30, 90, and 180 days post-surgery
Anastomotic Leakage Severity (Clavien-Dindo Grade)
Distribution of anastomotic leakage severity among participants with leakage, classified by Clavien-Dindo Grade A, B, or C. Reported as number and percentage of participants per grade.
Time frame: 30, 90, and 180 days post-surgery
Anastomotic Bleeding Rate
Incidence of anastomotic bleeding, including serosal/mucosal oozing and active bleeding at the anastomotic site. Reported as the percentage of participants with bleeding
Time frame: 30, 90, and 180 days post-surgery
Anastomotic Stricture Rate
Incidence of anastomotic stricture, assessed by digital examination, endoscopy (anastomotic diameter in mm), or barium enema. Reported as the percentage of participants with stricture
Time frame: 90 and 180 days post-surgery
Plan to share: Yes — The specific de-identified Individual Participant Data (IPD) to be shared (personal identifiers removed) includes: Baseline Data: Age, gender, primary diagnosis (e.g., colon/rectal cancer), specific high-risk factors for anastomotic leakage, and relevant medical history. Intraoperative Data: Immediate stapling effect of SIS patch-aided anastomosis (e.g., seromuscular dehiscence, bleeding, need for additional suturing) and anastomotic device type. Postoperative Data: Follow-up results at ±30/±90/±180 days (anastomotic leakage/grading, healing status, adverse events with details, concomitant medications/devices). Safety Data: Baseline/follow-up lab results (e.g., coagulation indices), vital signs, and safety-related physical exam findings. IPD sharing complies with laws/ethical approval, is for SIS patch safety/effectiveness research, and requires a data sharing agreement for security.
Supporting information: Study protocol
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Jun 2027, 29 months after the start.
Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 29 months is close to that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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