Digestive System Surgical ProceduresNCT07921732
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
A study testing Biological Mesh for Digestive Surgery and Conventional Stapling in people with Digestive System Surgical Procedures and Anastomosis, Surgical, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The goal of the Phase III clinical trial is to evaluate whether using a biological mesh helps improve the efficacy and safety of alimentary tract reconstruction surgery. In digestive surgery, bleeding or leakage at the surgical connection (anastomosis) remains a significant clinical challenge. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Digestive System Surgical Procedures, Anastomosis, Surgical, Postoperative Hemorrhage
- What is being tested?
- Biological Mesh for Digestive Surgery and Conventional Stapling
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years (inclusive).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- American Society of Anesthesiologists (ASA) physical status classification of Grade I, II, or III.
- Scheduled for laparoscopic or open surgery involving gastrointestinal-related anastomosis.
- Participants must meet the following laboratory criteria:
- Hemoglobin (Hb) ≥ 90 g/L;
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- White Blood Cell (WBC) count ≥ 3 × 10^9/L and ≤ 12 × 10^9/L;
- Platelet (PLT) count ≥ 100 × 10^9/L;
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2 × Upper Limit of Normal (ULN);
- Total Bilirubin (T-Bil) ≤ 1.5 × ULN;
- Serum Creatinine (Cr) ≤ 1 × ULN;
- Serum Albumin ≥ 30 g/L.
- Able to understand and sign the informed consent form.
Who cannot join
- Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test.
- Patients with coagulation disorders.
- Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, or uncontrolled chronic systemic diseases such as diabetes or hypertension.
- Clinically significant cardiac diseases, including congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias or hypertension poorly controlled by medication, myocardial infarction within the past 6 months, or cardiac insufficiency.
- Presence of severe uncontrolled recurrent infections.
- Known allergy or hypersensitivity to collagen or bovine-derived materials.
- Current participation in other clinical trials for drugs or medical devices that have not yet reached the primary endpoint time point.
- Any other medical condition (including follow-up and compliance issues) that, in the investigator's opinion, may or will interfere with the study process.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Medical Ethics committee of NanFang Hospital, 020-62787238, nfyyec@163.com
About this study
The goal of the Phase III clinical trial is to evaluate whether using a biological mesh helps improve the efficacy and safety of alimentary tract reconstruction surgery. In digestive surgery, bleeding or leakage at the surgical connection (anastomosis) remains a significant clinical challenge. This study explores whether reinforcing the anastomosis with a biological mesh can effectively reduce these risks and significantly enhance the reliability of the surgical procedure.
The main objectives of this study are:
Read more
To evaluate the effectiveness of the biological mesh in reducing bleeding points at the surgical site during the procedure.
To assess the role of the mesh in lowering the risk of postoperative complications, such as anastomotic leaks or stenosis, within 90 days after surgery.
Study Groups:
Experimental Group: Participants who undergo alimentary tract reconstruction with biological mesh reinforcement during surgery.
Control Group: Participants who undergo conventional surgical procedures without the use of mesh.
Participant Flow:
Participants will undergo a health evaluation before surgery to confirm they meet the study criteria. Following the procedure, participants will receive standard postoperative care and return for follow-up clinic visits 30 and 90 days after surgery to monitor their recovery.
- Conditions
- Digestive System Surgical Procedures, Anastomosis, Surgical, Postoperative Hemorrhage, Anastomotic Leaks
- Being tested
- Biological Mesh for Digestive Surgery, Conventional Stapling
- Medical subject headings
- Postoperative Hemorrhage, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological Mesh for Digestive SurgeryDevice
A biological mesh specifically designed for reinforcement during alimentary tract reconstruction. It is used in conjunction with linear stapling devices during the surgical procedure to enhance the integrity of the anastomosis. The mesh provides mechanical support to the staple line, aiming to improve surgical outcomes by reducing intraoperative bleeding and the risk of postoperative complications, including leaks and stenosis, among other related conditions.
Conventional StaplingProcedure or surgery
Participants will undergo conventional alimentary tract reconstruction using a linear stapler alone, without the use of reinforcing mesh.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Biological Mesh Reinforcement | Experimental | Participants in this group will undergo alimentary tract reconstruction using a linear stapler with biological mesh reinforcement. During the procedure, researchers will record intraoperative raw data, including the number of bleeding points per unit length within 10 minutes after stapling, among other related clinical indicators. Following the surgery, participants will receive standard postoperative care. A 90-day monitoring period will be conducted to track anastomotic-related complications, specifically focusing on postoperative bleeding, leakage, stenosis, and other related conditions. Receives: Device: Biological Mesh for Digestive Surgery |
| Control Group: Conventional Stapling | Active comparator | Participants in this group will undergo conventional alimentary tract reconstruction using a linear stapler alone. Identical intraoperative raw data regarding bleeding points and other related clinical indicators will be recorded for baseline comparison. Following the surgery, participants will receive standard postoperative care. Consistent with the experimental group, a 90-day monitoring period will track anastomotic-related complications, such as postoperative bleeding, leakage, stenosis, and other related conditions. Receives: Procedure: Conventional Stapling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bleeding points per unit length
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.
Measured: Intraoperatively (within 10 minutes after stapling)
Secondary outcomes (4)
Number of arterial pulsatile bleeding points per unit length
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.
Measured: Intraoperatively (within 10 minutes after stapling)
Time required for hemostatic management
The total duration (in minutes) spent on performing additional hemostasis or reinforcement procedures for bleeding points at the anastomosis or staple line.
Measured: During the surgical procedure
Total operative time
The total duration of the surgery.
Measured: From the start of surgery to the end of surgery
Incidence of anastomotic-related complications
The percentage of participants experiencing complications specifically related to the surgical connection, including anastomotic bleeding, anastomotic leakage, and anastomotic stenosis.
Measured: Up to 90 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start6 May 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921732
- Sponsor's protocol ID
- NFEC-2025-248
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
- ClinicalTrials.gov ID
- NCT07921732
- Acronym / sponsor ID
- NFEC-2025-248
- Conditions
- Digestive System Surgical Procedures, Anastomosis, Surgical, Postoperative Hemorrhage, Anastomotic Leaks
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the Phase III clinical trial is to evaluate whether using a biological mesh helps improve the efficacy and safety of alimentary tract reconstruction surgery. In digestive surgery, bleeding or leakage at the surgical connection (anastomosis) remains a significant clinical challenge. This study explores whether reinforcing the anastomosis with a biological mesh can effectively reduce these risks and significantly enhance the reliability of the surgical procedure.
The main objectives of this study are:
To evaluate the effectiveness of the biological mesh in reducing bleeding points at the surgical site during the procedure.
To assess the role of the mesh in lowering the risk of postoperative complications, such as anastomotic leaks or stenosis, within 90 days after surgery.
Study Groups:
Experimental Group: Participants who undergo alimentary tract reconstruction with biological mesh reinforcement during surgery.
Control Group: Participants who undergo conventional surgical procedures without the use of mesh.
Participant Flow:
Participants will undergo a health evaluation before surgery to confirm they meet the study criteria. Following the procedure, participants will receive standard postoperative care and return for follow-up clinic visits 30 and 90 days after surgery to monitor their recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Biological Mesh Reinforcement | Experimental | Device: Biological Mesh for Digestive SurgeryParticipants in this group will undergo alimentary tract reconstruction using a linear stapler with biological mesh reinforcement. During the procedure, researchers will record intraoperative raw data, including the number of bleeding points per unit length within 10 minutes after stapling, among other related clinical indicators. Following the surgery, participants will receive standard postoperative care. A 90-day monitoring period will be conducted to track anastomotic-related complications, specifically focusing on postoperative bleeding, leakage, stenosis, and other related conditions. |
| Control Group: Conventional Stapling | Active comparator | Procedure: Conventional StaplingParticipants in this group will undergo conventional alimentary tract reconstruction using a linear stapler alone. Identical intraoperative raw data regarding bleeding points and other related clinical indicators will be recorded for baseline comparison. Following the surgery, participants will receive standard postoperative care. Consistent with the experimental group, a 90-day monitoring period will track anastomotic-related complications, such as postoperative bleeding, leakage, stenosis, and other related conditions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged 18 to 75 years (inclusive).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- American Society of Anesthesiologists (ASA) physical status classification of Grade I, II, or III.
- Scheduled for laparoscopic or open surgery involving gastrointestinal-related anastomosis.
- Participants must meet the following laboratory criteria:
Key exclusion criteria (8 listed)
- Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test.
- Patients with coagulation disorders.
- Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, or uncontrolled chronic systemic diseases such as diabetes or hypertension.
- Clinically significant cardiac diseases, including congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias or hypertension poorly controlled by medication, myocardial infarction within the past 6 months, or cardiac insufficiency.
- Presence of severe uncontrolled recurrent infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological Mesh for Digestive SurgeryA biological mesh specifically designed for reinforcement during alimentary tract reconstruction. It is used in conjunction with linear stapling devices during the surgical procedure to enhance the integrity of the anastomosis. The mesh provides mechanical support to the staple line, aiming to improve surgical outcomes by reducing intraoperative bleeding and the risk of postoperative complications, including leaks and stenosis, among other related conditions. | Device | Experimental Group: Biological Mesh Reinforcement |
| Conventional StaplingParticipants will undergo conventional alimentary tract reconstruction using a linear stapler alone, without the use of reinforcing mesh. | Procedure or surgery | Control Group: Conventional Stapling |
Primary outcome
Number of bleeding points per unit length
Time frame: 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.
4 secondary outcomes
Number of arterial pulsatile bleeding points per unit length
Time frame: Intraoperatively (within 10 minutes after stapling)
Time required for hemostatic management
Time frame: During the surgical procedure
Total operative time
Time frame: From the start of surgery to the end of surgery
Incidence of anastomotic-related complications
Time frame: Up to 90 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological Mesh for Digestive Surgery and Conventional Stapling in people with Digestive System Surgical Procedures and Anastomosis, Surgical, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanfeng Hu (+86 13632494551, yfenghu@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bleeding points per unit length (time frame: Intraoperatively (within 10 minutes after stapling)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.