Multicenter Study of SIS Patch in High-risk Colorectal Anastomosis
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- 18 és 85 év között vagy?
Forrás: NCT07931300: ki vehet részt
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Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Beijing Chao Yang Hospital
- Azonosító
- NCT07931300
- A regiszteradat frissítve
- 2026. november 12.
- Eredeti leírás
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:A teljes eredeti leírásKevesebb
Multicenter Real-world Study of SIS Reinforcement Patch in High-risk Colorectal Anastomosis and Exploration of the Mechanism Promoting Anastomotic Healing
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.
Bevonási feltételek: Patients must meet all the following criteria to be enrolled in this trial:; Aged between 18 and 85 years (inclusive); Determined by the researcher to have the following high-risk factors for anastomotic leakage (i.e., high-risk anastomosis):; Abdominopelvic abscess caused by gastrointestinal perforation, fecal contamination due to intraoperative intestinal rupture, intestinal inflammatory edema caused by intestinal internal fistula; ② Colorectal anastomosis in patients with a history of ulcerative colitis; ③ Patients who received hormone therapy and stopped within half a year; ④ Patients who received abdominopelvic radiotherapy, tumor chemotherapy, anti-tumor targeted therapy, or anti-tumor angiogenesis therapy; ⑤ Intestinal anastomosis in patients with renal failure receiving hemodialysis or peritoneal dialysis; ⑥ Intestinal anastomosis in patients with intestinal edema caused by acute intestinal obstruction, especially rectal anastomosis; ⑦ Aged over 75 years.
Kizáró feltételek: Patients who meet any of the following exclusion criteria shall not be enrolled in this trial:; Patients with imaging evidence of distant metastases (e.g., liver, lung, bone) at initial diagnosis; Patients with coagulation disorders (① Prothrombin Time (PT) > 18 seconds or exceeding 1.5 times the upper limit of the normal reference range with clinically significant abnormalities; or ② Activated Partial Thromboplastin Time (APTT) > 60 seconds or exceeding 1.5 times the upper limit of the normal reference range with clinically significant abnormalities); Patients who used platelet receptor antagonists within 48 hours before surgery; Patients who cannot accept porcine-derived devices due to religious, ethnic, or other reasons; Patients with an expected survival time of less than 6 months; Pregnant or lactating patients, or patients planning to become pregnant during the trial; Patients who participated in or are currently participating in a drug clinical trial within 3 months, or participated in or are currently participating in other medical device clinical trials within 30 days; Patients who cannot understand the trial protocol due to language or intellectual impairment and cannot complete follow-up during the trial period; Patients deemed unsuitable for enrollment by the researcher for other reasons.