Incisional HerniaH-PACSNCT03090022
Hernia-Prophylaxis in Acute Care Surgery H-PACS
A study testing Strattice and Single running suture of abdominal fascia in people with Incisional Hernia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population. Patients requiring emergency laparotomy are at high risk for the development of incisional hernia and fascial dehiscence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Strattice and Single running suture of abdominal fascia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2017to 5 Oct 2020
- 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
- Patients undergoing emergency midline laparatomy
- Emergency laparoscopy with expected conversion to midline laparatomy
- Written informed consent
Who cannot join
- ASA ≥5
- Septic shock
- Pregnant women
- Prior mesh Implantation
- Known sensitivity for porcine material or Polysorbate 20
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Visceral and transplant surgery, Berne University Hospital
Bern, 3010
About this study
Official title: Prophylactic Mesh Implantation in Patients Undergoing Requiring Emergency Laparatomy for the Prevention of Incisional Hernia:A Randomized Controlled Trial
Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population. Patients requiring emergency laparotomy are at high risk for the development of incisional hernia and fascial dehiscence. Among this population the incidence of incisional hernia in patients undergoing emergency surgery varies between 33-54%. Incisional hernias are associated with a high morbidity rate, such as intestinal incarceration, chronic discomfort, pain, and reoperation and typically require implantation of a synthetic mesh in a later second operation. Fascial dehiscence represents an acute form of dehiscence and has been observed in up to 24.1% and is associated with a mortality rate up to 44%.
The gold standard for abdominal wall closure during elective and emergency operations is a running slowly absorbable suture. In the elective situation it has been shown that prophylactic mesh implantation in high risk patients reduced the incidence of incisional hernia significantly.
Read more
The investigators and others have shown that mesh implantation in patients undergoing emergency laparotomy or in contaminated abdominal cavities are safe .
With a randomized controlled trial the investigators now aim to compare the incidence of incisional hernia after prophylactic mesh implantation versus standard of care in patients requiring emergency laparotomy.
- Conditions
- Incisional Hernia
- Being tested
- Strattice, Single running suture of abdominal fascia
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StratticeProcedure or surgery
Also called Acellular porcine dermal mesh
Intra-abdominally Fixation
Single running suture of abdominal fasciaProcedure or surgery
Intra-abdominal suture
| Study group | Role | What they receive |
|---|---|---|
| Mesh implantation | Active comparator | Prior to closure of the abdominal wall a mesh will be implanted in a standardized fashion Receives: Procedure: Strattice |
| Single running suture of abdominal fascia | Active comparator | The closure of the abdominal wall a Standard technique will be applied using a running suture Receives: Procedure: Single running suture of abdominal fascia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incidence of death
follow-up
Measured: up to 18 months
Number of patients with hernia free survival
follow-up
Measured: up to 18 months
Secondary outcomes (8)
Number of patients with postoperative fascial dehiscence
follow-up
Measured: 30 days
Number of postoperative mortality
survival
Measured: 90 days
Number of surgical site infections postoperative
follow-up
Measured: 30 days
Number of postoperative intestinal fistulas
follow-up
Measured: 30 days
Number of small bowel obstructions
follow-up
Measured: 18 months
Number of patients with postoperative pain
follow-up
Measured: 18 months
Number of postoperative mesh infections
follow-up
Measured: 18 months
Number of postoperative mesh explantations
follow-up
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Mar 2017
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Beldi, Prof. Dr., Principal investigator, Inselspital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090022
- Sponsor's protocol ID
- 2016-02212
- Other IDs
- 2016
- Acronym
- H-PACS
- Status last verified
- Oct 2021
- First submitted
- 20 Mar 2017
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Mesh Implantation in Patients Undergoing Requiring Emergency Laparatomy for the Prevention of Incisional Hernia:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03090022
- Acronym / sponsor ID
- H-PACS / 2016-02212
- Conditions
- Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 24 Mar 2017 (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.
Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population. Patients requiring emergency laparotomy are at high risk for the development of incisional hernia and fascial dehiscence. Among this population the incidence of incisional hernia in patients undergoing emergency surgery varies between 33-54%. Incisional hernias are associated with a high morbidity rate, such as intestinal incarceration, chronic discomfort, pain, and reoperation and typically require implantation of a synthetic mesh in a later second operation. Fascial dehiscence represents an acute form of dehiscence and has been observed in up to 24.1% and is associated with a mortality rate up to 44%.
The gold standard for abdominal wall closure during elective and emergency operations is a running slowly absorbable suture. In the elective situation it has been shown that prophylactic mesh implantation in high risk patients reduced the incidence of incisional hernia significantly.
The investigators and others have shown that mesh implantation in patients undergoing emergency laparotomy or in contaminated abdominal cavities are safe .
With a randomized controlled trial the investigators now aim to compare the incidence of incisional hernia after prophylactic mesh implantation versus standard of care in patients requiring emergency laparotomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh implantation | Active comparator | Procedure: StratticePrior to closure of the abdominal wall a mesh will be implanted in a standardized fashion |
| Single running suture of abdominal fascia | Active comparator | Procedure: Single running suture of abdominal fasciaThe closure of the abdominal wall a Standard technique will be applied using a running suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing emergency midline laparatomy
- Emergency laparoscopy with expected conversion to midline laparatomy
- Written informed consent
Key exclusion criteria (5 listed)
- ASA ≥5
- Septic shock
- Pregnant women
- Prior mesh Implantation
- Known sensitivity for porcine material or Polysorbate 20
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 |
|---|---|---|
| StratticeAlso: Acellular porcine dermal meshIntra-abdominally Fixation | Procedure or surgery | Mesh implantation |
| Single running suture of abdominal fasciaIntra-abdominal suture | Procedure or surgery | Single running suture of abdominal fascia |
Primary outcome
Number of incidence of death
Time frame: up to 18 months
follow-up
Number of patients with hernia free survival
Time frame: up to 18 months
follow-up
8 secondary outcomes
Number of patients with postoperative fascial dehiscence
Time frame: 30 days
Number of postoperative mortality
Time frame: 90 days
Number of surgical site infections postoperative
Time frame: 30 days
Number of postoperative intestinal fistulas
Time frame: 30 days
Number of small bowel obstructions
Time frame: 18 months
Number of patients with postoperative pain
Time frame: 18 months
Number of postoperative mesh infections
Time frame: 18 months
Number of postoperative mesh explantations
Time frame: 18 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 26 Oct 2021.
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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.
Guido Beldi, Prof. Dr. principal investigator
Inselspital Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strattice and Single running suture of abdominal fascia in people with Incisional Hernia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 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 26 Oct 2021. 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 Switzerland. 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?
Number of incidence of death (time frame: up to 18 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?
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 2021.