Incisional HerniasProphMeshNCT01203553
Prophylactic Mesh Implantation for the Prevention of Incisional Hernia
An observational study of Incisional Hernias, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Incisional hernias are primarily repaired using prosthetic meshes. In Switzerland such meshes are mainly implanted via open or laparoscopic approach. The differential impact of these two types of surgical technique on recurrence rate will be investigated with this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernias
- What is being tested?
- Abdominal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Mar 2017
- 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: Population with a high risk for incisional hernia formation
Who may be able to join
- Occurrence of at least two of the following factors:
- Male gender
- Malignant tumor present
- Body mass index above 25
- Previous laparatomy
- Elective operation
- Patient > 18 years
- Written informed consent
Who cannot join
- Previous intra-abdominal mesh placement
- Emergency procedures
- Previous incisional hernia
- Inflammatory bowel disease
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: Mesh Implantation for Prophylaxis of Incisional Hernia
Incisional hernias are primarily repaired using prosthetic meshes. In Switzerland such meshes are mainly implanted via open or laparoscopic approach. The differential impact of these two types of surgical technique on recurrence rate will be investigated with this study.
With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia repair will be investigated prospectively. Hernia recurrence is the main outcome measure.
Read the detailed description
Background
Incisional hernia is one of the most common complication in general abdominal surgery. An overall incidence of 20% has been found in retrospective studies, ranging in up to 50% of patients with selected risk factors such as obesity.
In the general surgical patient the current standard is the closure of the abdominal wall using a running, slowly absorbable suture. With this well established clinical practice the incidence remains high and incisional hernia repair must be performed frequently in order to treat patients'symptoms and to prevent progression of the hernia an possible complications.
Consequently, in high risk patients prophylactic mesh implantation is performed routinely in our institution.
Objective
- Occurrence of at least two of the following factors:
- Male gender
- Malignant tumor present
- Body mass index above 25kg/m2
- Previous laparotomy
- Elective operation
- Patient >18 years
- Written informed consent
Methods
Prospective,two armed, controlled, randomized study
- Conditions
- Incisional Hernias
- Being tested
- Abdominal surgery
- Keywords
- Incisional hernias, Prophylaxis, Preperitoneal mesh
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal surgeryProcedure or surgery
Intraoperative mesh implantation
| Study group | Role | What they receive |
|---|---|---|
| Control Group | The main operation will be performed as planned. For the closure of the abdominal wall, a standard technique will be applied using a running suture of PDS 1 loop. The distance of the sutures to the fascial border is 1cm and the distance between two stitches is not more than 1cm. The total length of suture is at least 4 times the total length of the abdominal incision Receives: Procedure: Abdominal surgery | |
| Treatment Group | The main operation will be performed as planned. Prior to the closure of the abdominal wall a mesh will be implanted in a standardized fashion: A Dynamesh IPOM mesh will be used for the present study. The mesh has a width of 15cm and is tailored to overlap lateral and cranial boarders at least 5cm. The mesh will be placed intra-abdominally and fixed using intra-abdominal stitches using Prolene 2/0 in all four corners. After the initial fixation of the mesh in all quadrants, the boarders of the mesh will be adapted using Prolene 2/0 running sutures. The fixation aims to prevent any intestinal structures to herniate onto the mesh. Afterwards, the abdominal wall is closed as described in the control group. Receives: Procedure: Abdominal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of incisional hernia
Measured: 3 years
Secondary outcomes (3)
Direct in-hospital costs
Measured: 3 years
Intraoperative complications
Measured: 3 years
Postoperative complications
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startJan 2011
- Primary completionMar 2017
- Study completionMar 2017
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 Incisional HerniasStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 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, Berne, University Hospital, Univesrity of Berne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203553
- Sponsor's protocol ID
- KEK 094/10
- Acronym
- ProphMesh
- Status last verified
- Apr 2017
- First submitted
- 14 Sep 2010
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kohler A, Lavanchy JL, Lenoir U, Kurmann A, Candinas D, Beldi G. Effectiveness of Prophylactic Intraperitoneal Mesh Implantation for Prevention of Incisional Hernia in Patients Undergoing Open Abdominal Surgery: A Randomized Clinical Trial. JAMA Surg. 2019 Feb 1;154(2):109-115. doi: 10.1001/jamasurg.2018.4221.
PubMed 30476940
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Implantation for Prophylaxis of Incisional Hernia
- ClinicalTrials.gov ID
- NCT01203553
- Acronym / sponsor ID
- ProphMesh / KEK 094/10
- Conditions
- Incisional Hernias
- Keywords
- Incisional hernias, Prophylaxis, Preperitoneal mesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 16 Sep 2010 (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.
Incisional hernias are primarily repaired using prosthetic meshes. In Switzerland such meshes are mainly implanted via open or laparoscopic approach. The differential impact of these two types of surgical technique on recurrence rate will be investigated with this study.
With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia repair will be investigated prospectively. Hernia recurrence is the main outcome measure.
Detailed description
Background
Incisional hernia is one of the most common complication in general abdominal surgery. An overall incidence of 20% has been found in retrospective studies, ranging in up to 50% of patients with selected risk factors such as obesity.
In the general surgical patient the current standard is the closure of the abdominal wall using a running, slowly absorbable suture. With this well established clinical practice the incidence remains high and incisional hernia repair must be performed frequently in order to treat patients'symptoms and to prevent progression of the hernia an possible complications.
Consequently, in high risk patients prophylactic mesh implantation is performed routinely in our institution.
Objective
- Occurrence of at least two of the following factors:
- Male gender
- Malignant tumor present
- Body mass index above 25kg/m2
- Previous laparotomy
- Elective operation
- Patient >18 years
- Written informed consent
Methods
Prospective,two armed, controlled, randomized study
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Procedure: Abdominal surgeryThe main operation will be performed as planned. For the closure of the abdominal wall, a standard technique will be applied using a running suture of PDS 1 loop. The distance of the sutures to the fascial border is 1cm and the distance between two stitches is not more than 1cm. The total length of suture is at least 4 times the total length of the abdominal incision |
| Treatment Group | – | Procedure: Abdominal surgeryThe main operation will be performed as planned. Prior to the closure of the abdominal wall a mesh will be implanted in a standardized fashion: A Dynamesh IPOM mesh will be used for the present study. The mesh has a width of 15cm and is tailored to overlap lateral and cranial boarders at least 5cm. The mesh will be placed intra-abdominally and fixed using intra-abdominal stitches using Prolene 2/0 in all four corners. After the initial fixation of the mesh in all quadrants, the boarders of the mesh will be adapted using Prolene 2/0 running sutures. The fixation aims to prevent any intestinal structures to herniate onto the mesh. Afterwards, the abdominal wall is closed as described in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population with a high risk for incisional hernia formation
Key inclusion criteria (8 listed)
- Occurrence of at least two of the following factors:
- Elective operation
- Patient > 18 years
- Written informed consent
Key exclusion criteria (4 listed)
- Previous intra-abdominal mesh placement
- Emergency procedures
- Previous incisional hernia
- Inflammatory bowel 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 |
|---|---|---|
| Abdominal surgeryIntraoperative mesh implantation | Procedure or surgery | Control Group, Treatment Group |
Primary outcome
Incidence of incisional hernia
Time frame: 3 years
3 secondary outcomes
Direct in-hospital costs
Time frame: 3 years
Intraoperative complications
Time frame: 3 years
Postoperative complications
Time frame: 3 years
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 11 Apr 2017.
- Derived from this study: PubMed 30476940Kohler A, Lavanchy JL, Lenoir U, Kurmann A, Candinas D, Beldi G. Effectiveness of Prophylactic Intraperitoneal Mesh Implantation for Prevention of Incisional Hernia in Patients Undergoing Open Abdominal Surgery: A Randomized Clinical Trial. JAMA Surg. 2019 Feb 1;154(2):109-115. doi: 10.1001/jamasurg.2018.4221.
Related trials for Incisional Hernias
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
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
RecruitingObservational study
Patient-Specific Biomechanical Modeling of Incisional Hernias Using Artificial Intelligence and Finite Element Analysis
Incisional Hernia
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
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
Berne, University Hospital, Univesrity of Berne, Switzerland
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 Incisional Hernias, 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 8 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: finished, as of the sponsor's last update on 11 Apr 2017. 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?
Incidence of incisional hernia (time frame: 3 years). 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 NCT01203553, 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 11 Apr 2017.