Parastomal HerniaAPOLLONCT06791642
Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique:
An observational study of Parastomal Hernia, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
Trial summary
This study focuses on improving the surgical repair of parastomal hernias (PSHs), which are a common complication for patients with stomas. The investigators are examining the effectiveness of a specific technique called the "sandwich method," which uses two layers of mesh to reinforce the hernia site and reduce… 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?
- Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 1 Jan 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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
Study population: The study population will consist of adult patients with a diagnosed parastomal hernia who are referred for surgical repair at participating hospitals. These patients are representative of individuals commonly managed in general and colorectal surgery practices, and they will be selected from both inpatient and outpatient settings.
Who may be able to join
- Specify the criteria for participating in the study in a bulleted list under each category heading ("Inclusion Criteria" and "Exclusion Criteria"). Include only one item per bullet.
Who cannot join
- Age below 18 years.
- Patients with recurrent parastomal hernia repairs requiring an open surgical approach.
- Evidence of active abdominal infection or sepsis at the time of surgery.
- Known allergies to mesh materials used in the study (e.g., Parietex™ or Synecor™).
- Presence of significant comorbidities making laparoscopic surgery unsafe (e.g., advanced cardiopulmonary disease).
- Pregnancy at the time of surgery.
- Inability to provide informed consent or comply with follow-up requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique: A Multicenter Study of Clinical Outcomes, Recurrence Rates, and Quality of Life Improvements
This study focuses on improving the surgical repair of parastomal hernias (PSHs), which are a common complication for patients with stomas. The investigators are examining the effectiveness of a specific technique called the "sandwich method," which uses two layers of mesh to reinforce the hernia site and reduce recurrence. The objective is to evaluate how well this method works over time, assess its impact on patient recovery and quality of life, and compare outcomes for different types of surgical materials used. This research aims to provide clearer guidance for surgeons and improve long-term results for patients undergoing PSH repair.
Read the detailed description
Study Description: Improving Surgical Outcomes for Parastomal Hernia Repair
Parastomal hernias (PSHs) are a common and challenging complication that occurs in patients with stomas-surgically created openings in the abdomen used to divert waste. These hernias can cause discomfort, limit daily activities, and require surgical intervention to repair. Despite advancements in surgical techniques, PSH repair remains a complex issue, with high recurrence rates and varying outcomes.
This study investigates the effectiveness of a specific surgical approach called the "sandwich technique" for PSH repair. This method uses two layers of mesh to reinforce the abdominal wall and provide extra support around the stoma, aiming to reduce the likelihood of hernia recurrence while maintaining the function of the stoma. The first layer of mesh is placed directly around the stoma in a "keyhole" fashion, and the second layer reinforces the surrounding abdominal wall in a broader "overlay" configuration.
The research evaluates multiple aspects of this technique:
- Effectiveness: Measuring recurrence rates over time, particularly for patients with larger hernias or recurrent hernias.
- Safety: Assessing complications such as infections, seromas (fluid accumulation), or mesh-related issues.
- Quality of Life (QoL): Using patient-reported surveys to evaluate how the repair impacts physical comfort, stoma care, body image, and social activities.
- Comparison of Materials: Analyzing outcomes for two commonly used mesh types-Parietex™ Composite Mesh and Synecor™ Hybrid Mesh-to determine if material selection affects long-term results.
The study incorporates the European Hernia Society (EHS) classification system to categorize hernia types based on size and complexity. This allows for a tailored approach to treatment and helps identify which patients may benefit most from specific surgical strategies.
While the sandwich technique has shown promise in reducing recurrence rates and enhancing recovery, this research seeks to provide stronger evidence to guide surgeons in selecting the best techniques and materials for PSH repair. By focusing on patient-centered outcomes and refining surgical methods, the study aims to improve long-term results and overall quality of life for individuals living with stomas.
- Conditions
- Parastomal Hernia
- Being tested
- Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique
- Keywords
- stoma, hernia, Laparoscopic repair
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Parastomal Hernia Repair Using the Sandwich TechniqueDevice
The sandwich technique was performed laparoscopically according to minimally invasive principles. Pneumoperitoneum was typically established using a Veress needle if the subcostal region was free from previous surgical scarring. For patients with prior extensive abdominal surgeries, a small laparotomy was performed to place the first 10-mm trocar directly under vision, ensuring safe entry into the peritoneal cavity. A 30° laparoscope was used throughout the procedure for enhanced visualization of the operative field.
Trocar placement was designed to optimize access and ergonomics. The primary trocar was placed either in the periumbilical region or in the left or right flank, depending on the patient's anatomy and stoma location. Mesh used:1. Parietex™ Composite Mesh (Medtronic, USA): A multifilament polyester mesh with an anti-adhesive collagen barrier to minimize visceral adhesions.
Laparoscopic Parastomal Hernia Repair Using the Sandwich TechniqueDevice
The sandwich technique was performed laparoscopically according to minimally invasive principles. Pneumoperitoneum was typically established using a Veress needle if the subcostal region was free from previous surgical scarring. For patients with prior extensive abdominal surgeries, a small laparotomy was performed to place the first 10-mm trocar directly under vision, ensuring safe entry into the peritoneal cavity. A 30° laparoscope was used throughout the procedure for enhanced visualization of the operative field.
Trocar placement was designed to optimize access and ergonomics. The primary trocar was placed either in the periumbilical region or in the left or right flank, depending on the patient's anatomy and stoma location. Mesh use Synecor™ Hybrid Mesh (BD, USA): A macroporous mesh combining polypropylene with a bioresorbable layer that degrades over time, leaving a durable support structure to promote tissue integration.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Parietex™ Composite Mesh | Group 1: Parietex™ Composite Mesh
This group consisted of patients who had their PSH repair performed using the Parietex™ Composite Mesh, a dual-layer synthetic mesh designed to promote tissue integration while minimizing the risk of adhesions. The Parietex™ mesh is composed of a macroporous structure on one side, which facilitates tissue ingrowth, and an anti-adhesive barrier on the other side to reduce complications such as bowel adhesions or erosion. This mesh was applied using the sandwich technique, combining a keyhole configuration around the stoma with an overlay reinforcement of the abdominal wall. Receives: Device: Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique | |
| Group 2: Synecor™ Hybrid Mesh | This group included patients who underwent PSH repair using the Synecor™ Hybrid Mesh, an advanced composite mesh that combines biologic and synthetic materials. The Synecor™ mesh integrates a bioresorbable layer for improved biocompatibility and tissue integration with a synthetic layer to enhance long-term strength and durability. It also incorporates anti-adhesive properties to minimize the risk of complications. Similar to the Parietex™ group, this mesh was used in the sandwich technique to provide dual-layer reinforcement.
Key features of this group:
* Mesh composition: Hybrid with bioresorbable and synthetic components for strength and tissue integration.
* Clinical outcomes assessed: Recurrence rates, SSIs, seromas, and mesh-related complications, including hematomas or bulging. Receives: Device: Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
hernia recurrence rate
defined as clinical or radiological confirmation of a recurrent parastomal hernia.
Measured: 12 months
hernia recurrence rate
defined as clinical or radiological confirmation of a recurrent parastomal hernia.
Measured: 24 months
Secondary outcomes (19)
Surgical Site Infections (SSIs)
The occurrence of surgical site infections was assessed as a critical indicator of postoperative morbidity. SSIs were monitored through clinical evaluations, including signs of redness, swelling, warmth, pain, and discharge at the surgical site, and were managed according to established guidelines.
Measured: 1 months
Surgical Site Infections (SSIs)
The occurrence of surgical site infections was assessed as a critical indicator of postoperative morbidity. SSIs were monitored through clinical evaluations, including signs of redness, swelling, warmth, pain, and discharge at the surgical site, and were managed according to established guidelines.
Measured: 3 months
Surgical Site Infections (SSIs)
The occurrence of surgical site infections was assessed as a critical indicator of postoperative morbidity. SSIs were monitored through clinical evaluations, including signs of redness, swelling, warmth, pain, and discharge at the surgical site, and were managed according to established guidelines.
Measured: 6 months
Surgical Site Infections (SSIs)
The occurrence of surgical site infections was assessed as a critical indicator of postoperative morbidity. SSIs were monitored through clinical evaluations, including signs of redness, swelling, warmth, pain, and discharge at the surgical site, and were managed according to established guidelines.
Measured: 12 months
Surgical Site Infections (SSIs)
The occurrence of surgical site infections was assessed as a critical indicator of postoperative morbidity. SSIs were monitored through clinical evaluations, including signs of redness, swelling, warmth, pain, and discharge at the surgical site, and were managed according to established guidelines.
Measured: 24 months
Number of Participants with Postoperative Seroma Formation
Accumulation of fluid at the surgical site, confirmed through physical examination or imaging.
Measured: 1 months
Number of Participants with Postoperative Seroma Formation:
Accumulation of fluid at the surgical site, confirmed through physical examination or imaging.
Measured: 3 months
Number of Participants with Postoperative Seroma Formation:
Accumulation of fluid at the surgical site, confirmed through physical examination or imaging.
Measured: 6 months
Number of Participants with Postoperative Seroma Formation:
Accumulation of fluid at the surgical site, confirmed through physical examination or imaging.
Measured: 12 months
Number of Participants with Postoperative Seroma Formation:
Accumulation of fluid at the surgical site, confirmed through physical examination or imaging.
Measured: 24 months
Number of Participants with Postoperative Hematoma Formation
Localized blood collection near the surgical site, evaluated clinically or with imaging as needed.
Measured: 1 months
Number of Participants with Postoperative Hematoma Formation
Localized blood collection near the surgical site, evaluated clinically or with imaging as needed.
Measured: 3 months
Number of Participants with Postoperative Hematoma Formation
Localized blood collection near the surgical site, evaluated clinically or with imaging as needed.
Measured: 6 months
Number of Participants with Postoperative Hematoma Formation
Localized blood collection near the surgical site, evaluated clinically or with imaging as needed.
Measured: 12 months
Number of Participants with Postoperative Hematoma Formation
Localized blood collection near the surgical site, evaluated clinically or with imaging as needed.
Measured: 24 months
Mesh-Related Complications:Bowel Adhesions
Abnormal fibrous connections between the bowel and mesh, potentially causing pain or obstruction.
Measured: until 24 months
Mesh-specific complications : Mesh Migration:
Displacement of the mesh from its intended position.
Measured: until 24 month
Mesh-Related Complications:Mesh Erosion into the Stoma
Displacement of the mesh from its intended position.
Measured: until 24 months
Number of Participants with Postoperative Bowel Obstruction
Episodes of bowel obstruction were recorded based on patient symptoms (e.g., abdominal distension, vomiting) and confirmed using imaging studies
Measured: until 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 31 participants (actual)
- Target duration
- 24 Months
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, PhD, Study director, Azienda Sanitaria Locale Napoli 2 Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791642
- Sponsor's protocol ID
- 20252819
- Acronym
- APOLLO
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Explanation for Not Sharing Individual Participant Data (IPD) Individual participant data (IPD) will not be shared due to the following considerations: 1. Patient Confidentiality: Sharing IPD may risk breaching participant privacy, even if anonymized, particularly given the detailed nature of surgical and clinical data. 2. Ethical Constraints: The consent obtained from participants does not include provisions for data sharing beyond the scope of this study. 3. Regulatory Compliance: Institutional policies and local regulations may limit the sharing of sensitive health information. 4. Data Ownership: The data is collected across multiple centers, and permissions for sharing may vary depending on institutional agreements and data governance policies. 5. Limited Generalizability of Raw Data: Given the study's small sample size and highly specialized focus, the broader utility of the raw IPD for external analysis is limited.
Publications
Antoniou SA, Agresta F, Garcia Alamino JM, Berger D, Berrevoet F, Brandsma HT, Bury K, Conze J, Cuccurullo D, Dietz UA, Fortelny RH, Frei-Lanter C, Hansson B, Helgstrand F, Hotouras A, Janes A, Kroese LF, Lambrecht JR, Kyle-Leinhase I, Lopez-Cano M, Maggiori L, Mandala V, Miserez M, Montgomery A, Morales-Conde S, Prudhomme M, Rautio T, Smart N, Smietanski M, Szczepkowski M, Stabilini C, Muysoms FE. European Hernia Society guidelines on prevention and treatment of parastomal hernias. Hernia. 2018 Feb;22(1):183-198. doi: 10.1007/s10029-017-1697-5. Epub 2017 Nov 13.
PubMed 29134456
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique: A Multicenter Study of Clinical Outcomes, Recurrence Rates, and Quality of Life Improvements
- ClinicalTrials.gov ID
- NCT06791642
- Acronym / sponsor ID
- APOLLO / 20252819
- Conditions
- Parastomal Hernia
- Keywords
- stoma, hernia, Laparoscopic repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 NordUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 24 Jan 2025 (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.
This study focuses on improving the surgical repair of parastomal hernias (PSHs), which are a common complication for patients with stomas. The investigators are examining the effectiveness of a specific technique called the "sandwich method," which uses two layers of mesh to reinforce the hernia site and reduce recurrence. The objective is to evaluate how well this method works over time, assess its impact on patient recovery and quality of life, and compare outcomes for different types of surgical materials used. This research aims to provide clearer guidance for surgeons and improve long-term results for patients undergoing PSH repair.
Detailed description
Study Description: Improving Surgical Outcomes for Parastomal Hernia Repair
Parastomal hernias (PSHs) are a common and challenging complication that occurs in patients with stomas-surgically created openings in the abdomen used to divert waste. These hernias can cause discomfort, limit daily activities, and require surgical intervention to repair. Despite advancements in surgical techniques, PSH repair remains a complex issue, with high recurrence rates and varying outcomes.
This study investigates the effectiveness of a specific surgical approach called the "sandwich technique" for PSH repair. This method uses two layers of mesh to reinforce the abdominal wall and provide extra support around the stoma, aiming to reduce the likelihood of hernia recurrence while maintaining the function of the stoma. The first layer of mesh is placed directly around the stoma in a "keyhole" fashion, and the second layer reinforces the surrounding abdominal wall in a broader "overlay" configuration.
The research evaluates multiple aspects of this technique:
- Effectiveness: Measuring recurrence rates over time, particularly for patients with larger hernias or recurrent hernias.
- Safety: Assessing complications such as infections, seromas (fluid accumulation), or mesh-related issues.
- Quality of Life (QoL): Using patient-reported surveys to evaluate how the repair impacts physical comfort, stoma care, body image, and social activities.
- Comparison of Materials: Analyzing outcomes for two commonly used mesh types-Parietex™ Composite Mesh and Synecor™ Hybrid Mesh-to determine if material selection affects long-term results.
The study incorporates the European Hernia Society (EHS) classification system to categorize hernia types based on size and complexity. This allows for a tailored approach to treatment and helps identify which patients may benefit most from specific surgical strategies.
While the sandwich technique has shown promise in reducing recurrence rates and enhancing recovery, this research seeks to provide stronger evidence to guide surgeons in selecting the best techniques and materials for PSH repair. By focusing on patient-centered outcomes and refining surgical methods, the study aims to improve long-term results and overall quality of life for individuals living with stomas.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Parietex™ Composite Mesh | – | Device: Laparoscopic Parastomal Hernia Repair Using the Sandwich TechniqueGroup 1: Parietex™ Composite Mesh This group consisted of patients who had their PSH repair performed using the Parietex™ Composite Mesh, a dual-layer synthetic mesh designed to promote tissue integration while minimizing the risk of adhesions. The Parietex™ mesh is composed of a macroporous structure on one side, which facilitates tissue ingrowth, and an anti-adhesive barrier on the other side to reduce complications such as bowel adhesions or erosion. This mesh was applied using the sandwich technique, combining a keyhole configuration around the stoma with an overlay reinforcement of the abdominal wall. |
| Group 2: Synecor™ Hybrid Mesh | – | Device: Laparoscopic Parastomal Hernia Repair Using the Sandwich TechniqueThis group included patients who underwent PSH repair using the Synecor™ Hybrid Mesh, an advanced composite mesh that combines biologic and synthetic materials. The Synecor™ mesh integrates a bioresorbable layer for improved biocompatibility and tissue integration with a synthetic layer to enhance long-term strength and durability. It also incorporates anti-adhesive properties to minimize the risk of complications. Similar to the Parietex™ group, this mesh was used in the sandwich technique to provide dual-layer reinforcement. Key features of this group: * Mesh composition: Hybrid with bioresorbable and synthetic components for strength and tissue integration. * Clinical outcomes assessed: Recurrence rates, SSIs, seromas, and mesh-related complications, including hematomas or bulging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients with a diagnosed parastomal hernia who are referred for surgical repair at participating hospitals. These patients are representative of individuals commonly managed in general and colorectal surgery practices, and they will be selected from both inpatient and outpatient settings.
Key inclusion criteria (1 listed)
- Specify the criteria for participating in the study in a bulleted list under each category heading ("Inclusion Criteria" and "Exclusion Criteria"). Include only one item per bullet.
Key exclusion criteria (7 listed)
- Age below 18 years.
- Patients with recurrent parastomal hernia repairs requiring an open surgical approach.
- Evidence of active abdominal infection or sepsis at the time of surgery.
- Known allergies to mesh materials used in the study (e.g., Parietex™ or Synecor™).
- Presence of significant comorbidities making laparoscopic surgery unsafe (e.g., advanced cardiopulmonary disease).
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 |
|---|---|---|
| Laparoscopic Parastomal Hernia Repair Using the Sandwich TechniqueThe sandwich technique was performed laparoscopically according to minimally invasive principles. Pneumoperitoneum was typically established using a Veress needle if the subcostal region was free from previous surgical scarring. For patients with prior extensive abdominal surgeries, a small laparotomy was performed to place the first 10-mm trocar directly under vision, ensuring safe entry into the peritoneal cavity. A 30° laparoscope was used throughout the procedure for enhanced visualization of the operative field. Trocar placement was designed to optimize access and ergonomics. The primary trocar was placed either in the periumbilical region or in the left or right flank, depending on the patient's anatomy and stoma location. Mesh used:1. Parietex™ Composite Mesh (Medtronic, USA): A multifilament polyester mesh with an anti-adhesive collagen barrier to minimize visceral adhesions. | Device | Group 1: Parietex™ Composite Mesh |
| Laparoscopic Parastomal Hernia Repair Using the Sandwich TechniqueThe sandwich technique was performed laparoscopically according to minimally invasive principles. Pneumoperitoneum was typically established using a Veress needle if the subcostal region was free from previous surgical scarring. For patients with prior extensive abdominal surgeries, a small laparotomy was performed to place the first 10-mm trocar directly under vision, ensuring safe entry into the peritoneal cavity. A 30° laparoscope was used throughout the procedure for enhanced visualization of the operative field. Trocar placement was designed to optimize access and ergonomics. The primary trocar was placed either in the periumbilical region or in the left or right flank, depending on the patient's anatomy and stoma location. Mesh use Synecor™ Hybrid Mesh (BD, USA): A macroporous mesh combining polypropylene with a bioresorbable layer that degrades over time, leaving a durable support structure to promote tissue integration. | Device | Group 2: Synecor™ Hybrid Mesh |
Primary outcome
hernia recurrence rate
Time frame: 12 months
defined as clinical or radiological confirmation of a recurrent parastomal hernia.
hernia recurrence rate
Time frame: 24 months
defined as clinical or radiological confirmation of a recurrent parastomal hernia.
19 secondary outcomes
Surgical Site Infections (SSIs)
Time frame: 1 months
Surgical Site Infections (SSIs)
Time frame: 3 months
Surgical Site Infections (SSIs)
Time frame: 6 months
Surgical Site Infections (SSIs)
Time frame: 12 months
Surgical Site Infections (SSIs)
Time frame: 24 months
Number of Participants with Postoperative Seroma Formation
Time frame: 1 months
Number of Participants with Postoperative Seroma Formation:
Time frame: 3 months
Number of Participants with Postoperative Seroma Formation:
Time frame: 6 months
Number of Participants with Postoperative Seroma Formation:
Time frame: 12 months
Number of Participants with Postoperative Seroma Formation:
Time frame: 24 months
Number of Participants with Postoperative Hematoma Formation
Time frame: 1 months
Number of Participants with Postoperative Hematoma Formation
Time frame: 3 months
Number of Participants with Postoperative Hematoma Formation
Time frame: 6 months
Number of Participants with Postoperative Hematoma Formation
Time frame: 12 months
Number of Participants with Postoperative Hematoma Formation
Time frame: 24 months
Mesh-Related Complications:Bowel Adhesions
Time frame: until 24 months
Mesh-specific complications : Mesh Migration:
Time frame: until 24 month
Mesh-Related Complications:Mesh Erosion into the Stoma
Time frame: until 24 months
Number of Participants with Postoperative Bowel Obstruction
Time frame: until 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Results publication: PubMed 29134456Antoniou SA, Agresta F, Garcia Alamino JM, Berger D, Berrevoet F, Brandsma HT, Bury K, Conze J, Cuccurullo D, Dietz UA, Fortelny RH, Frei-Lanter C, Hansson B, Helgstrand F, Hotouras A, Janes A, Kroese LF, Lambrecht JR, Kyle-Leinhase I, Lopez-Cano M, Maggiori L, Mandala V, Miserez M, Montgomery A, Morales-Conde S, Prudhomme M, Rautio T, Smart N, Smietanski M, Szczepkowski M, Stabilini C, Muysoms FE. European Hernia Society guidelines on prevention and treatment of parastomal hernias. Hernia. 2018 Feb;22(1):183-198. doi: 10.1007/s10029-017-1697-5. Epub 2017 Nov 13.
- Individual participant dataSharing planned: Undecided. Explanation for Not Sharing Individual Participant Data (IPD) Individual participant data (IPD) will not be shared due to the following considerations: 1. Patient Confidentiality: Sharing IPD may risk breaching participant privacy, even if anonymized, particularly given the detailed nature of surgical and clinical data. 2. Ethical Constraints: The consent obtained from participants does not include provisions for data sharing beyond the scope of this study. 3. Regulatory Compliance: Institutional policies and local regulations may limit the sharing of sensitive health information. 4. Data Ownership: The data is collected across multiple centers, and permissions for sharing may vary depending on institutional agreements and data governance policies. 5. Limited Generalizability of Raw Data: Given the study's small sample size and highly specialized focus, the broader utility of the raw IPD for external analysis is limited.
Related trials for Parastomal Hernia
Not yet recruitingObservational study
Improving Decisions and Outcomes in Parastomal Hernia Surgery
Parastomal Hernia
RecruitingObservational study
Risk Factors for Mesh Infection After Abdominal Wall Reconstruction
Incisional Hernia, Ventral Hernia
Recruiting
Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery
Parastomal Hernia
Recruiting
Laparoscopic Total Extraperitoneal Plasty as a Modification of Sugabecker's Operation
Parastomal Hernia
Not yet recruiting
A Prospective Randomized Controlled Trial Comparing Extraperitoneal Stoma Creation Via the Arcuate Line Approach Versus Conventional Transperitoneal Stoma Formation for the Prevention of Parastomal Hernia
Parastomal Hernia, Rectal Surgery
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, PhD study director
Azienda Sanitaria Locale Napoli 2 Nord
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parastomal Hernia, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 27 Jan 2025. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hernia recurrence rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06791642, which also lists 1 linked publication.
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 27 Jan 2025.