Hernia, AbdominalIMPACTNCT06111287

Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia

An observational study of Hernia, Abdominal and Hernia Incisional, run by Azienda Sanitaria Locale Napoli 2 Nord at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: Hernia, Abdominal, Hernia Incisional
How many people: 432 participants
Where: 2 sitesItaly
Study dates: Jan 2015to Jul 2020
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: From January 2015 and May 2020, all the patients affected by primary or recurrent complex abdominal hernias undergoing open component posterior separation with trasversus abdomen release referring to 6 centres, were considered for enrollment in the study.

Who may be able to join

age ≥16 years,
primary or recurrent complex abdominal hernias with more than >10 cm midline defects

Who cannot join

follow-up data lower than 36-months, patients with a stoma for whom closure was not planned during the abdominal hernia repair

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

Francdesco Pizza
Naples, Naples, 80035
Francesco Pizza
Naples, 80131

Other trials in Italy

About this study

Official title: : Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia Repair: an Italian Multicenter Cohort Study

This multicenter retrospective study analyzed data from 308 patients who underwent open Posterior Component separation with Trasversus release for primary or recurrent complex abdominal hernias between 2015 and 2020. The primary endpoint was the rate of Hernia Recurrence and Mesh Bulging at 3, 6, 12, 24, and 36 months. Secondary outcomes included surgical site events and were assessed using the Pain scale.

Read the detailed description

Study design This study is reported according to the STROBE statement for cohort studies A retrospective multicentric study was conducted to analyze the surgical outcomes of patients undergoing open with Posterior Component separation with Trasversus release for inisional hernia. It was conducted according to the ethical principles stated in the Declaration of Helsinki. Written informed consent was obtained from all subjects.

Study setting and study population From January 2015 and May 2020, all the patients affected by primary or recurrent complex abdominal hernias undergoing open Posterior Component separation with Trasversus release referring to 6 centers, were considered for enrollment in the study. Inclusion criteria were age ≥16 years, primary or recurrent complex abdominal hernias with more than >10 cm midline defects Exclusion criteria were follow-up data lower than 36 months, patients with a stoma for whom closure was not planned during the abdominal hernia repair

Conditions: Hernia, Abdominal, Hernia Incisional
Medical subject headings: Hernia, Abdominal, Incisional Hernia

What is being measured

The primary outcome is the main question the study is designed to answer.

Hernia Recurrence
In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Measured: 3 months
Hernia Recurrence
In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Measured: 6 months
Hernia Recurrence
In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Measured: 12 months
Hernia Recurrence
In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Measured: 24 months
Hernia Recurrence
In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Measured: 36 months
Mesh Bulging
In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Measured: 3 months
Mesh Bulging
In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Measured: 12 months
Mesh Bulging
In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Measured: 24 months
Mesh Bulging
In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Measured: 36 months
surgical site events
Regarding the surgical site events, the classification of wound events was assigned according to the likelihood and degree of wound contamination at the time of the operation, as stated in the Centre for Disease Control and Prevention wound classification (superficial, deep or organ space)
Measured: 1 months
Number of patients affected by Superficial surgical site infection
Superficial infections according to Clavien-Dindo criteria
Measured: 1 months

Secondary outcomes (10)

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
Number of patients affected by organ space infections
Organ space infections according to Clavien-Dindo criteria
Measured: Within 30 days postoperatively
Number of patients affected by Surgical Site Occurence
Surgical Site Occurence Reported according to the Ventral Hernia Working Group (VHWG) definitions
Measured: Within 30 days postoperatively
Postoperative pain
Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month.
Postoperative pain
Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 3 month.
Postoperative pain
Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 6 month.
Postoperative pain
Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 12 month.
Postoperative pain
Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 24 month.
Postoperative pain
Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 36 month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Jul 2020

First posted1 Nov 2023
Study startJan 2015
Primary completionMay 2020
Study completionJul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hernia, AbdominalStudies 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: Retrospective
Enrolment: 432 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06111287
Sponsor's protocol ID: 1988
Acronym: IMPACT
Status last verified: Oct 2023
First submitted: 23 Oct 2023
Last updated: 1 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Gastroschisis
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia

All Hernia, Abdominal trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: : Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia Repair: an Italian Multicenter Cohort Study
ClinicalTrials.gov ID: NCT06111287
Acronym / sponsor ID: IMPACT / 1988
Conditions: Hernia, Abdominal, Hernia Incisional
Study type: Observational
Recruitment status: Completed
Enrolment: 432 participants (actual)
Lead sponsor: Azienda Sanitaria Locale Napoli 2 NordUniversity, hospital or other
Study start: Jan 2015 (actual)
Primary completion: May 2020 (actual)
Study completion: Jul 2020 (actual)
First posted: 1 Nov 2023 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: From January 2015 and May 2020, all the patients affected by primary or recurrent complex abdominal hernias undergoing open component posterior separation with trasversus abdomen release referring to 6 centres, were considered for enrollment in the study.

Key inclusion criteria (2 listed)

age ≥16 years,
primary or recurrent complex abdominal hernias with more than >10 cm midline defects

Key exclusion criteria (1 listed)

follow-up data lower than 36-months, patients with a stoma for whom closure was not planned during the abdominal hernia repair

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Hernia Recurrence
Time frame: 3 months
In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Hernia Recurrence
Time frame: 6 months
In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Hernia Recurrence
Time frame: 12 months
In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Hernia Recurrence
Time frame: 24 months
In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Hernia Recurrence
Time frame: 36 months
In details, Hernia Recurrence was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Mesh Bulging
Time frame: 3 months
In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Mesh Bulging
Time frame: 12 months
In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Mesh Bulging
Time frame: 24 months
In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
Mesh Bulging
Time frame: 36 months
In details, Mesh Bulging was clinically defined as any visible or palpable ''blowout'' in the abdominal wall. computed tomography scan evaluation was carried out by a radiologist with 10 years of gastrointestinal computed tomography scan experience.
surgical site events
Time frame: 1 months
Regarding the surgical site events, the classification of wound events was assigned according to the likelihood and degree of wound contamination at the time of the operation, as stated in the Centre for Disease Control and Prevention wound classification (superficial, deep or organ space)
Number of patients affected by Superficial surgical site infection
Time frame: 1 months
Superficial infections according to Clavien-Dindo criteria

10 secondary outcomes

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
Number of patients affected by organ space infections
Time frame: Within 30 days postoperatively
Number of patients affected by Surgical Site Occurence
Time frame: Within 30 days postoperatively
Postoperative pain
Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month.
Postoperative pain
Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 3 month.
Postoperative pain
Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 6 month.
Postoperative pain
Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 12 month.
Postoperative pain
Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 24 month.
Postoperative pain
Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 36 month.

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 1 Nov 2023.
Individual participant dataSharing planned: Yes

Related trials for Hernia, Abdominal

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Gastroschisis
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia

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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hernia, Abdominal and Hernia Incisional, 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 2 inclusion and 1 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 1 Nov 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?

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 (time frame: 3 months). The study lists 11 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 NCT06111287.

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 1 Nov 2023.