PeritonitisPerProMeNCT01802164
Prophylactic Mesh Implantation in Patients With Peritonitis for the Prevention of Incisional Hernia
A study testing A non-absorbable composite mesh (Ethicon Physiomesh) in people with Peritonitis and Incisional Hernia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
In patients undergoing laparotomy, the incidence of abdominal wall related complications such as incisional hernia is very high. In particular in patients with peritonitis undergoing laparotomy the incidence of incisional hernia is up to 54.3%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonitis, Incisional Hernia, Surgery
- What is being tested?
- A non-absorbable composite mesh (Ethicon Physiomesh)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2013to Apr 2015
- 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 with clinical signs of peritonitis
- Emergency laparotomy or laparoscopy with conversion to laparotomy
- Patients > 18 years
- Written informed consent
Who cannot join
- Previous implanted mesh
- Incisional hernia present
- Small bowel obstruction without bowel resection
- Surgery for cholecystitis
- Inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
- Polytrauma patients
- Pregnant women
- Women younger than 45 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of visceral and transplant surgery, Berne University Hospital
Bern, Canton of Bern, 3010
About this study
Official title: Prophylactic Mesh Implantation in Patients With Peritonitis for the Prevention of Incisional Hernia: A Randomized Controlled Trial
In patients undergoing laparotomy, the incidence of abdominal wall related complications such as incisional hernia is very high. In particular in patients with peritonitis undergoing laparotomy the incidence of incisional hernia is up to 54.3%. Furthermore, these patients are at great risk for development of postoperative fascial dehiscence.
The gold standard of abdominal wall closure is a running slowly absorbable suture irrespective of the presence of peritonitis. Implantation of an intraperitoneal mesh potentially reduces the incidence of incisional hernia.
In a series of high risk patients in which we implanted non-absorbable intraperitoneal mesh prophylactically we reduced the incidence of incisional hernia down to 3.2%.
Read the detailed description
Background
Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population [1,2]. An incisional hernia is defined as any abdominal wall gap with or without a bulge in the area of postoperative scar perceptible or palpable by clinical examination or imaging [3]. Overall incidence of incisional hernia at our institution with a follow-up of five years was 14%, whereas in patients undergoing liver transplantation we found an incidence of incisional hernia of 25% in a prospective study [2]. However, patients with peritonitis are at very high risk for the development of incisional hernia. Moussavian et al demonstrated an incidence of incisional hernia of 54.3% after a median follow-up of 6 years in patients undergoing emergency surgery for secondary peritonitis [4]. In patients undergoing surgical therapy for secondary peritonitis, redo surgery because of complications associated with the abdominal wall, such as fascial dehiscence and surgical site infection are frequent. Impaired wound healing in response to the systemic inflammatory response and the high incidence of surgical site infection might render the abdominal wall even more susceptible for incisional hernia, compared with the general surgical population [5,6]. Furthermore, patients with peritonitis undergoing emergency laparotomy develop fascial dehiscence in up to 24.1% [7]. Fascial dehiscence requires reoperation and is associated with a mortality rate up to 44% [8].
Objective
To compare prophylactic mesh implantation to conventional abdominal wall closure in patients undergoing emergency laparotomy for peritonitis.
Methods
Implantation of a non-resorbable intraperitoneal mesh in patients with peritonitis undergoing emergency laparotomy.
- Conditions
- Peritonitis, Incisional Hernia, Surgery
- Being tested
- A non-absorbable composite mesh (Ethicon Physiomesh)
- Medical subject headings
- Peritonitis, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A non-absorbable composite mesh (Ethicon Physiomesh)Device
To compare prophylactic mesh implantation to conventional abdominal wall closure in patients undergoing emergency laparotomy for peritonitis.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Conventional abdominal wall closure with mesh implantation Receives: Device: A non-absorbable composite mesh (Ethicon Physiomesh) |
| 2 | No intervention | Conventional abdominal wall closure without mesh implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with incisional hernia
Measured: 54 months
Secondary outcomes (8)
Number of patients with facial dehiscence
Measured: 54 months
Mortality
Measured: 54 months
Number of patients with surgical site infection
Measured: 54 months
Number of patients with intestinal fistula
Measured: 54 months
Number of patients with small bowel obstruction
Measured: 54 months
Number of patients with postoperative pain
Measured: 54 months
Number of patients with low grade mesh infection or chronic subclinical inflammation
Measured: 54 months
Number of patients with mesh explantation
Measured: 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Recruitment problems due to very restricted inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies 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
- None (open label)
- Enrolment
- 5 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. med., Principal investigator, Dep. of visceral and transplant surgery; Univesrity Hiospital, Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802164
- Sponsor's protocol ID
- 006/12
- Acronym
- PerProMe
- Status last verified
- Jun 2015
- First submitted
- 15 Feb 2013
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Mesh Implantation in Patients With Peritonitis for the Prevention of Incisional Hernia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01802164
- Acronym / sponsor ID
- PerProMe / 006/12
- Conditions
- Peritonitis, Incisional Hernia, Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems due to very restricted inclusion criteria
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Mar 2013 (estimated)
- 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.
In patients undergoing laparotomy, the incidence of abdominal wall related complications such as incisional hernia is very high. In particular in patients with peritonitis undergoing laparotomy the incidence of incisional hernia is up to 54.3%. Furthermore, these patients are at great risk for development of postoperative fascial dehiscence.
The gold standard of abdominal wall closure is a running slowly absorbable suture irrespective of the presence of peritonitis. Implantation of an intraperitoneal mesh potentially reduces the incidence of incisional hernia.
In a series of high risk patients in which we implanted non-absorbable intraperitoneal mesh prophylactically we reduced the incidence of incisional hernia down to 3.2%.
Detailed description
Background
Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population [1,2]. An incisional hernia is defined as any abdominal wall gap with or without a bulge in the area of postoperative scar perceptible or palpable by clinical examination or imaging [3]. Overall incidence of incisional hernia at our institution with a follow-up of five years was 14%, whereas in patients undergoing liver transplantation we found an incidence of incisional hernia of 25% in a prospective study [2]. However, patients with peritonitis are at very high risk for the development of incisional hernia. Moussavian et al demonstrated an incidence of incisional hernia of 54.3% after a median follow-up of 6 years in patients undergoing emergency surgery for secondary peritonitis [4]. In patients undergoing surgical therapy for secondary peritonitis, redo surgery because of complications associated with the abdominal wall, such as fascial dehiscence and surgical site infection are frequent. Impaired wound healing in response to the systemic inflammatory response and the high incidence of surgical site infection might render the abdominal wall even more susceptible for incisional hernia, compared with the general surgical population [5,6]. Furthermore, patients with peritonitis undergoing emergency laparotomy develop fascial dehiscence in up to 24.1% [7]. Fascial dehiscence requires reoperation and is associated with a mortality rate up to 44% [8].
Objective
To compare prophylactic mesh implantation to conventional abdominal wall closure in patients undergoing emergency laparotomy for peritonitis.
Methods
Implantation of a non-resorbable intraperitoneal mesh in patients with peritonitis undergoing emergency laparotomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: A non-absorbable composite mesh (Ethicon Physiomesh)Conventional abdominal wall closure with mesh implantation |
| 2 | No intervention | –Conventional abdominal wall closure without mesh implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with clinical signs of peritonitis
- Emergency laparotomy or laparoscopy with conversion to laparotomy
- Patients > 18 years
- Written informed consent
Key exclusion criteria (8 listed)
- Previous implanted mesh
- Incisional hernia present
- Small bowel obstruction without bowel resection
- Surgery for cholecystitis
- Inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
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 |
|---|---|---|
| A non-absorbable composite mesh (Ethicon Physiomesh)To compare prophylactic mesh implantation to conventional abdominal wall closure in patients undergoing emergency laparotomy for peritonitis. | Device | 1 |
Primary outcome
Number of patients with incisional hernia
Time frame: 54 months
8 secondary outcomes
Number of patients with facial dehiscence
Time frame: 54 months
Mortality
Time frame: 54 months
Number of patients with surgical site infection
Time frame: 54 months
Number of patients with intestinal fistula
Time frame: 54 months
Number of patients with small bowel obstruction
Time frame: 54 months
Number of patients with postoperative pain
Time frame: 54 months
Number of patients with low grade mesh infection or chronic subclinical inflammation
Time frame: 54 months
Number of patients with mesh explantation
Time frame: 54 months
Results and safety
The study was stopped early (reason given: Recruitment problems due to very restricted inclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
Related trials for Peritonitis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
Recruiting
Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis
Fecal Peritonitis, Secondary Peritonitis
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. med. principal investigator
Dep. of visceral and transplant surgery; Univesrity Hiospital, 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 A non-absorbable composite mesh (Ethicon Physiomesh) in people with Peritonitis and 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 16 Jun 2015. 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 was stopped early (reason given: Recruitment problems due to very restricted inclusion criteria). Results are not available in the source record.
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 patients with incisional hernia (time frame: 54 months). 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 16 Jun 2015.