Multicenter Study of SIS Patch in High-risk Colorectal Anastomosis
NCT07931300, Not applicable, Recruiting, Beijing Chao Yang Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Multicenter Study of SIS Patch in High-risk Colorectal Anastomosis | ClinicalTrials.gov |
| NCT number | NCT07931300 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 255 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beijing Chao Yang Hospital | ClinicalTrials.gov |
| Conditions | Colorectal Cancer | ClinicalTrials.gov |
| Interventions | SIS Patch Intervention for High - Risk Colorectal Anastomosis | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Intraoperative Anastomotic Immediate Defect Rate | Surgery day (intraoperative) | 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. | ClinicalTrials.gov |
| Primary | 30-Day Anastomotic Leakage Rate | 30 days post-surgery (Visit 2) | 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. | ClinicalTrials.gov |
| Secondary | 90-Day Anastomotic Leakage Rate | 90 days post-surgery (Visit 3) | 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. | ClinicalTrials.gov |
| Secondary | 180-Day Anastomotic Leakage Rate | 180 days post-surgery (Visit 4) | 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. | ClinicalTrials.gov |
| Secondary | Anastomotic Healing Rate | 30, 90, and 180 days post-surgery | 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. | ClinicalTrials.gov |
| Secondary | Wound Healing Defect Rate | 30, 90, and 180 days post-surgery | 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. | ClinicalTrials.gov |
| Secondary | Postoperative Infection Rate | 30, 90, and 180 days post-surgery | Incidence of postoperative infection, including surgical site infection. Reported as the percentage of participants with infection. | ClinicalTrials.gov |
| Secondary | Time to Perianastomotic Drain Removal | From surgery to drain removal (assessed by 30 days) | Time from surgery to removal of the perianastomotic drain. Reported in days. | ClinicalTrials.gov |
| Secondary | Time to Resumption of Oral Intake | From surgery to oral intake (assessed by 30 days) | Time from surgery to resumption of oral intake. Reported in days. | ClinicalTrials.gov |
| Secondary | Additional Treatments for Anastomotic Leakage | 30, 90, and 180 days post-surgery | 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. | ClinicalTrials.gov |
| Secondary | Anastomotic Leakage Severity (Clavien-Dindo Grade) | 30, 90, and 180 days post-surgery | 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. | ClinicalTrials.gov |
| Secondary | Anastomotic Bleeding Rate | 30, 90, and 180 days post-surgery | Incidence of anastomotic bleeding, including serosal/mucosal oozing and active bleeding at the anastomotic site. Reported as the percentage of participants with bleeding | ClinicalTrials.gov |
| Secondary | Anastomotic Stricture Rate | 90 and 180 days post-surgery | Incidence of anastomotic stricture, assessed by digital examination, endoscopy (anastomotic diameter in mm), or barium enema. Reported as the percentage of participants with stricture | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)