Stoma Site Incisional HerniaNCT05627284
A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
A study testing Stoma reversal with bio-mesh placement in people with Stoma Site Incisional Hernia, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the safety and effectiveness of stoma reversal combining bio-mesh placement in patients with high risk of stoma site incisional hernia (SSIH). The main questions it aims to answer are: Whether bio-mesh placement is safe for patients with a high risk of SSIH. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stoma Site Incisional Hernia
- What is being tested?
- Stoma reversal with bio-mesh placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age: 18-75 years old;
- Patients should have colonic prophylactic stoma and have not received reversal yet;
- There are no obvious signs of tumor recurrence or metastasis in tumor patients before stoma resection;
- No serious underlying diseases, can tolerate general anesthesia surgery
- Preoperative ECOG (Eastern Cooperative Oncology Group) physical status score 0/1;
- Preoperative ASA (American Society of Anesthesiologists) grade I-III;
- Without vital organs function failure;
- All patients and their families signed informed consent before surgery.
Who cannot join
- Incapacitated persons;
- With a history of other types of hernia;
- Those who have had hernia mesh implantation before;
- Those who are allergic to bio-mesh or their components before;
- Combined with other surgeries;
- Severe mental illness;
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- Severe respiratory disease;
- Severe liver and kidney insufficiency;
- Those who have absolute contraindications to surgery;
- Suffering from severe bleeding disorders or obvious abnormal coagulation function;
- History of unstable angina or myocardial infarction within 6 months;
- History of cerebral infarction or cerebral hemorrhage within 6 months;
- Continuous intravenous application of glucocorticoid within 1 month;
- The patient has participated or is participating in other clinical studies (within 6 months).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Meilin Jiang, Dr., +86 025-68182923, gyethics@163.com
About this study
The goal of this clinical trial is to explore the safety and effectiveness of stoma reversal combining bio-mesh placement in patients with high risk of stoma site incisional hernia (SSIH). The main questions it aims to answer are:
- Whether bio-mesh placement is safe for patients with a high risk of SSIH.
- Whether stoma reversal combining bio-mesh placement is a preventive strategy for patients with high risk of SSIH.
- Whether stoma reversal combining bio-mesh placement will trigger other complications.
Participants who are eligible and are enrolled in this study will receive stoma reversal combining bio-mesh placement surgery. After that, they will be followed up for one year to evaluate the occurrence of SSIH and other complications.
- Conditions
- Stoma Site Incisional Hernia
- Being tested
- Stoma reversal with bio-mesh placement
- Keywords
- Stoma Site Incisional Hernia, Colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stoma reversal with bio-mesh placementProcedure or surgery
Patients will receive stoma reversal. During the surgery, a bio-mesh is placed beyond the peritoneum on the surgical site to strengthen the abdominal wall.
| Study group | Role | What they receive |
|---|---|---|
| Stoma reversal with bio-mesh placement | Experimental | Not described Receives: Procedure: Stoma reversal with bio-mesh placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
stoma site incisional hernia
Hernia occurs on the primary stoma site
Measured: one-year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start1 Oct 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma Site Incisional HerniaStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627284
- Sponsor's protocol ID
- 2022-LCYJ-PY-33
- Status last verified
- Oct 2022
- First submitted
- 16 Nov 2022
- Last updated
- 25 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
- ClinicalTrials.gov ID
- NCT05627284
- Acronym / sponsor ID
- 2022-LCYJ-PY-33
- Conditions
- Stoma Site Incisional Hernia
- Keywords
- Stoma Site Incisional Hernia, Colon cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Nov 2022 (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 this clinical trial is to explore the safety and effectiveness of stoma reversal combining bio-mesh placement in patients with high risk of stoma site incisional hernia (SSIH). The main questions it aims to answer are:
- Whether bio-mesh placement is safe for patients with a high risk of SSIH.
- Whether stoma reversal combining bio-mesh placement is a preventive strategy for patients with high risk of SSIH.
- Whether stoma reversal combining bio-mesh placement will trigger other complications.
Participants who are eligible and are enrolled in this study will receive stoma reversal combining bio-mesh placement surgery. After that, they will be followed up for one year to evaluate the occurrence of SSIH and other complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stoma reversal with bio-mesh placement | Experimental | Procedure: Stoma reversal with bio-mesh placement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18-75 years old;
- Patients should have colonic prophylactic stoma and have not received reversal yet;
- There are no obvious signs of tumor recurrence or metastasis in tumor patients before stoma resection;
- No serious underlying diseases, can tolerate general anesthesia surgery
- Preoperative ECOG (Eastern Cooperative Oncology Group) physical status score 0/1;
Key exclusion criteria (14 listed)
- Incapacitated persons;
- With a history of other types of hernia;
- Those who have had hernia mesh implantation before;
- Those who are allergic to bio-mesh or their components before;
- Combined with other surgeries;
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 |
|---|---|---|
| Stoma reversal with bio-mesh placementPatients will receive stoma reversal. During the surgery, a bio-mesh is placed beyond the peritoneum on the surgical site to strengthen the abdominal wall. | Procedure or surgery | Stoma reversal with bio-mesh placement |
Primary outcome
stoma site incisional hernia
Time frame: one-year after surgery
Hernia occurs on the primary stoma site
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
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Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
Neoplasms Malignant, Rectal Cancer
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stoma reversal with bio-mesh placement in people with Stoma Site Incisional Hernia, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 25 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonghuan Mao, Dr (+86 15151877330, maoyonghuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stoma site incisional hernia (time frame: one-year after surgery). 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 25 Nov 2022.