Parastomal HerniaNCT04749329
Use of Resorbable Prosthetic Mesh "Ante Rectus" as Prevention of Parastomal Hernia.
A study testing Mesh Group in people with Parastomal Hernia, run by Azienda Sanitaria Locale Napoli 2 Nord at 2 sites in Italy.
Trial summary
The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Mesh Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Aug 2024to 1 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- endo colostomy
- Informed consent
Who cannot join
- age < 18 years;
- life expectancy < 24 months (as estimated by the operating surgeon)
- pregnancy
- immunosuppressant therapy within 2 weeks before surgery
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Aslnapoli2Nord
Naples, 80131
francesco pizza, md phd, francesco.pizza@libero.it
dario d'antonio, md, dario.dantonio@libero.it
- Not yet recruiting
francesco Pizza
Naples, 80131
francesco pizza, md phd, francesco_pizza@libero.it
About this study
Official title: Randomized Double-blind Study on the Use of Resorbable Prosthetic Mesh "Ante Rectus" as a Prevention of Parastomal Hernia in Patients Undergoing Terminal Colostomy
The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.
Read the detailed description
Several surgical scenarios include colon diversion as part of their management. Among them, the most frequent conditions requiring colostomy are abdominal malignancies, large bowel diverticulitis, Inflammatory Bowel Disease, bowel obstruction or perforation and postoperative complications such as anastomotic leakage. Colostomy related morbidity includes retraction, infection, prolapse, skin problems and parastomal hernia. Parastomal Hernia is a quite common late complication, with a clinical rate up to 55%, reaching 80% when assessed by Computer Tomography. Although Parastomal Hernia is often asymptomatic, significant morbidity exists, including pain, intermittent obstruction, stoma leakage, skin irritation and pouching, often reducing patients' Quality of Life. Several surgical options are available for Parastomal Hernia repair, many of them supporting the use of mesh to strengthen the fascia. However, results are often disappointing with quite high recurrence rates, rising up to 33%, even with the use of a mesh. Several studies have been published, testing effectiveness and safety of a prophylactic mesh in vertical laparotomy closure to prevent incisional hernia.
The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.
- Conditions
- Parastomal Hernia
- Being tested
- Mesh Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh GroupDevice
All MG patients underwent the procedure with ante rectus positioned prophylactic mesh according to the following standardized technique. A BIO-A circular-shaped mesh measuring 8X10 cm in diameter is prepared with an internal 2 cm hole to let the bowel pass.
An at least 8x8 cm space is created between the anterior rectus sheath and the rectus abdominis muscle and, then, the mesh is positioned. The bowel is passed through the rectus muscle via the circular incision in the middle of the mesh. Single absorbable monofilament sutures anchored the mesh laterally in the ante rectus pocket, while medially the mesh is fixed with four stitches to the colon and to both the anterior rectal sheet. The stoma is attached to the skin similarly to CG patients.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | no mesh was used for end colostomy fashions |
| Mesh Group | Experimental | Mesh of Bio A was used for end colostomy fashions Receives: Device: Mesh Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Parastomal Hernia at clinical control.
Detect of paratoia hernia
Measured: 3 months
Rate of Parastomal Hernia at clinical control.
Detect of paratoia hernia
Measured: 6 months
Rate of Parastomal Hernia at clinical control.
Detect of paratoia hernia
Measured: 12 months
Rate of Parastomal Hernia at clinical control.
Detect of paratoia hernia
Measured: 24 months
Secondary outcomes (6)
Rate of Parastomal Hernia at tomography observation.
detect of parastomal hernia
Measured: 3 months follow-up
Rate of Parastomal Hernia at tomography observation.
detect of parastomal hernia
Measured: 6 months follow-up
Rate of Parastomal Hernia at tomography observation.
detect of parastomal hernia
Measured: 12 months follow-up
Rate of Parastomal Hernia at tomography observation.
detect of parastomal hernia
Measured: 24 months follow-up
Number of patients affected by Superficial surgical site infections
Superficial infections according to Clavien-Dindo criteria
Measured: Within 30 days postoperatively
Number of patients affected by Deep surgical site infections
Deep surgical site infections according to Clavien-Dindo criteria
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a Binary outcome superiority trial. The sample size was calculated by Sealed Envelope Ltd. 2012. The calculation was based on the evaluation of PH rate at 3, 6, 12 and 24 months postoperatively in patients undergoing colostomy. In literature same trials reported a decrease in the incidence of PH in the mesh groups versus suture alone (xx). Therefore, we hypothesized a decrease of PH between Control and Mesh group of 25% (from 35 % to 10%). It was estimated that 49 subjects per group would be required to detect an absolute improvement of 25% (35% vs 10%) in the primary outcome between the two groups, with two-tailed α of 0.05 (2-sided 5% significance level) and a power of 80%. Data analysis was conducted according to an intention-to-treat approach. Loss to follow-up was estimated in about 10% of included patients. Therefore, a total of 110 patients (55 for each group) were included in the study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pizza, Azienda Sanitaria Locale Napoli 2 Nord
- Investigators
- Francesco Pizza, Md, PhD, Principal investigator, Azienda Sanitaria Locale Napoli 2 Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749329
- Sponsor's protocol ID
- 212128
- Status last verified
- Oct 2023
- First submitted
- 7 Feb 2021
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Study on the Use of Resorbable Prosthetic Mesh "Ante Rectus" as a Prevention of Parastomal Hernia in Patients Undergoing Terminal Colostomy
- ClinicalTrials.gov ID
- NCT04749329
- Acronym / sponsor ID
- 212128
- Conditions
- Parastomal Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 NordUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 11 Feb 2021 (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 aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.
Detailed description
Several surgical scenarios include colon diversion as part of their management. Among them, the most frequent conditions requiring colostomy are abdominal malignancies, large bowel diverticulitis, Inflammatory Bowel Disease, bowel obstruction or perforation and postoperative complications such as anastomotic leakage. Colostomy related morbidity includes retraction, infection, prolapse, skin problems and parastomal hernia. Parastomal Hernia is a quite common late complication, with a clinical rate up to 55%, reaching 80% when assessed by Computer Tomography. Although Parastomal Hernia is often asymptomatic, significant morbidity exists, including pain, intermittent obstruction, stoma leakage, skin irritation and pouching, often reducing patients' Quality of Life. Several surgical options are available for Parastomal Hernia repair, many of them supporting the use of mesh to strengthen the fascia. However, results are often disappointing with quite high recurrence rates, rising up to 33%, even with the use of a mesh. Several studies have been published, testing effectiveness and safety of a prophylactic mesh in vertical laparotomy closure to prevent incisional hernia.
The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study is a Binary outcome superiority trial. The sample size was calculated by Sealed Envelope Ltd. 2012. The calculation was based on the evaluation of PH rate at 3, 6, 12 and 24 months postoperatively in patients undergoing colostomy. In literature same trials reported a decrease in the incidence of PH in the mesh groups versus suture alone (xx). Therefore, we hypothesized a decrease of PH between Control and Mesh group of 25% (from 35 % to 10%). It was estimated that 49 subjects per group would be required to detect an absolute improvement of 25% (35% vs 10%) in the primary outcome between the two groups, with two-tailed α of 0.05 (2-sided 5% significance level) and a power of 80%. Data analysis was conducted according to an intention-to-treat approach. Loss to follow-up was estimated in about 10% of included patients. Therefore, a total of 110 patients (55 for each group) were included in the study.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –no mesh was used for end colostomy fashions |
| Mesh Group | Experimental | Device: Mesh GroupMesh of Bio A was used for end colostomy fashions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- endo colostomy
- Informed consent
Key exclusion criteria (4 listed)
- age < 18 years;
- life expectancy < 24 months (as estimated by the operating surgeon)
- pregnancy
- immunosuppressant therapy within 2 weeks before surgery
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 |
|---|---|---|
| Mesh GroupAll MG patients underwent the procedure with ante rectus positioned prophylactic mesh according to the following standardized technique. A BIO-A circular-shaped mesh measuring 8X10 cm in diameter is prepared with an internal 2 cm hole to let the bowel pass. An at least 8x8 cm space is created between the anterior rectus sheath and the rectus abdominis muscle and, then, the mesh is positioned. The bowel is passed through the rectus muscle via the circular incision in the middle of the mesh. Single absorbable monofilament sutures anchored the mesh laterally in the ante rectus pocket, while medially the mesh is fixed with four stitches to the colon and to both the anterior rectal sheet. The stoma is attached to the skin similarly to CG patients. | Device | Mesh Group |
Primary outcome
Rate of Parastomal Hernia at clinical control.
Time frame: 3 months
Detect of paratoia hernia
Rate of Parastomal Hernia at clinical control.
Time frame: 6 months
Detect of paratoia hernia
Rate of Parastomal Hernia at clinical control.
Time frame: 12 months
Detect of paratoia hernia
Rate of Parastomal Hernia at clinical control.
Time frame: 24 months
Detect of paratoia hernia
6 secondary outcomes
Rate of Parastomal Hernia at tomography observation.
Time frame: 3 months follow-up
Rate of Parastomal Hernia at tomography observation.
Time frame: 6 months follow-up
Rate of Parastomal Hernia at tomography observation.
Time frame: 12 months follow-up
Rate of Parastomal Hernia at tomography observation.
Time frame: 24 months follow-up
Number of patients affected by Superficial surgical site infections
Time frame: Within 30 days postoperatively
Number of patients affected by Deep surgical site infections
Time frame: Within 30 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- 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. This study is not recruiting at the moment.
Francesco Pizza, Md, PhD principal investigator
Azienda Sanitaria Locale Napoli 2 Nord
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesh Group in people with Parastomal Hernia, run by Azienda Sanitaria Locale Napoli 2 Nord at 2 sites in Italy.
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 3 inclusion and 4 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 Francesco Pizza, Md, PhD (3338275449, francesco_pizza@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Parastomal Hernia at clinical control. (time frame: 3 months). The study lists 4 primary outcomes in all. 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 26 Oct 2023.