Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
NCT07921732, Not applicable, Recruiting, Nanfang Hospital, Southern Medical University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery | ClinicalTrials.gov |
| NCT number | NCT07921732 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 144 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Nanfang Hospital, Southern Medical University | ClinicalTrials.gov |
| Conditions | Digestive System Surgical Procedures, Anastomosis, Surgical, Postoperative Hemorrhage, Anastomotic Leaks | ClinicalTrials.gov |
| Interventions | Biological Mesh for Digestive Surgery, Conventional Stapling | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of bleeding points per unit length | Intraoperatively (within 10 minutes after stapling) | The number of bleeding points on the staple line or anastomosis that require clinical hemostasis or suture reinforcement within 10 minutes after stapler firing, divided by the total length of the line. Observation sites include: gastric resection margins, duodenal closure margins, intestinal closure margins, gastrointestinal anastomosis, esophagogastric anastomosis, esophagojejunal anastomosis, enteroenteric anastomosis, and others. | ClinicalTrials.gov |
| Secondary | Number of arterial pulsatile bleeding points per unit length | Intraoperatively (within 10 minutes after stapling) | The number of arterial pulsatile bleeding points per unit length on the staple line or anastomosis requiring clinical hemostasis within 10 minutes after firing. Observation sites are consistent with the primary outcome. | ClinicalTrials.gov |
| Secondary | Time required for hemostatic management | During the surgical procedure | The total duration (in minutes) spent on performing additional hemostasis or reinforcement procedures for bleeding points at the anastomosis or staple line. | ClinicalTrials.gov |
| Secondary | Total operative time | From the start of surgery to the end of surgery | The total duration of the surgery. | ClinicalTrials.gov |
| Secondary | Incidence of anastomotic-related complications | Up to 90 days post-surgery | The percentage of participants experiencing complications specifically related to the surgical connection, including anastomotic bleeding, anastomotic leakage, and anastomotic stenosis. | 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)