Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for Prevention of Incisional Hernia: a Multi Center, Double-blind, Randomized Controlled Trial
Primary Purpose
Incisional Hernia, Emergency Laparotomy, Midline Laparotomy
Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Prophylactic self gripping mesh
Slowly absorbable continuous monofilament suture
Sponsored by
About this trial
This is an interventional prevention trial for Incisional Hernia
Eligibility Criteria
Inclusion Criteria:
- Midline emergency laparotomy for any gastrointestinal indication
Exclusion Criteria:
• Previous ventral hernia repair with mesh in the midline
Previous inguinal or femoral hernia repair by any technique with mesh is accepted
- Previous WHO class of physical activity 3-4 (WHO 3 more than 50% of time at rest, WHO 4 stays at rest most of the time)
- Relaparotomy
- Indication for laparotomy is incarcerated hernia
- Pregnant or suspected pregnancy
- <18 years
- Metastastic malignancy of any origin
- Planned osteomyelitis
- Patients living geographically distant and/or unwilling to return for follow-ups
- No informed consent
- Subject participates in another RCT Intra-operative exclusion criteria applicable for both randomization groups
- Abdomen is left open
- Second look laparotomy planned
- Ostomy created at the operation
- Inability to keep the mesh securely out of the peritoneal cavity or close the anterior fascia
- Intra-abdominal malignancy diagnosed at the operation
- >2 cm hernia in midline
Sites / Locations
- Jorvi Hospital
- Helsinki University Hospital
- Lahti Central Hospital
- Oulu University Hospital
- Seinäjoki Central Hospital
- Tampere University Hospital
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Prophylactic self gripping mesh (Program, Medtronic) will be placed in rectorectus space to prevent incisional hernia.
Abdomen of the patients in the control group will be closed by using small stitch closure with suture to wound length of 4:1 and slowly absorbable monofilament suture.
Outcomes
Primary Outcome Measures
Incidence of incisional hernia
Incidence of incisional hernia, either symptomatic or asymptomatic detected clinically and/or radiologically
Secondary Outcome Measures
Comprehensive Complication Index
Comprehensive Complication Index
Surgical site infection (SSI) rate
Surgical site infection (SSI) rate defined by CDC classification of surgical site infection
Fascial rupture
Incidence of fascial rupture
Incisional hernia
Incisional hernia incidence during long-term follow-up
Incisional hernia repair rate
Incisional hernia repair rate during follow-up
Re-operations
Re-operations due to mesh- or hernia related indications
Quality of life by RAND-36
Quality of life defined by RAND-36
Quality of life by Promis
Quality of life defined by Promis questionnaire
Quality of life by AAS
Quality of life defined by AAS questionnaire
Cost analysis
All differences in costs between the groups will be analyzed
Full Information
NCT ID
NCT04311788
First Posted
March 7, 2020
Last Updated
February 3, 2023
Sponsor
University of Oulu
Collaborators
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04311788
Brief Title
Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for Prevention of Incisional Hernia: a Multi Center, Double-blind, Randomized Controlled Trial
Official Title
Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for Prevention of Incisional Hernia: a Multi Center, Double-blind, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
February 3, 2023 (Anticipated)
Study Completion Date
March 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
Collaborators
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
244 patients, who have an emergency midline laparotomy for any gastrointestinal reason, will be randomized in a 1:1 ratio either to mesh group with a retrorectus prophylactic self-gripping mesh or to control group with 4:1 small stitch closure by continuous monofilament suture. They will be followed up at 30 days, 2 and 5 years to detect the incidence of incisional hernia.
Detailed Description
Incisional hernia (IH) is a common complication of abdominal wall surgery. Its' incidence varies greatly (2-30 %) among studies. The incisional hernia incidence is influenced by several factors, such as closing technique, follow-up time and the modality of radiological investigations, patient characteristics and co-morbidities as well as indication and type for surgery.
European Hernia Society (EHS) guideline strongly recommends to utilise a non-midline approach to a laparotomy whenever possible to decrease the incidence of incisional hernia. However, this is clearly not an option in an emergency laparotomy, as midline incision is the fastest and the best visualizing opening to explore the whole abdominal cavity in an emergency setting.
For elective midline incisions, evidence-based recommendation is to perform a continuous suturing technique with slowly absorbable monofilament suture when closing the incision. Suturation should be done performing a single layer aponeurotic closure technique without separate closure of the peritoneum. A small bites technique with a suture to wound length (SL/WL) ratio at least 4:1 is the current recommended method of fascial closure.
Prophylactic mesh augmentation in a non-emergency setting appears effective and safe and can be suggested for high-risk patients. However, no recommendations can be given on the optimal technique to close emergency laparotomy incisions because of lack of evidence. This problem should be emphasized on due to high rates of IH after emergency laparotomy. All this makes the use of prophylactic mesh in the emergency setting an interesting proposition, as it may decrease the rate of IHs. However, there are concerns over potential mesh related complications including infection, chronic pain, seromas and bowel fistulas especially in emergency situations like peritonitis and intestinal obstruction. There is preliminary evidence published about the safety and efficiency of the prevention of IHs using meshes in the emergency laparotomy closure even in contaminated conditions.
In the resent systematic review and meta-analysis, only results of 2 studies and altogether 299 patients were eligible for the analysis. Swiss case-control study reported an IH rate of 3,2% (2/63) in the mesh group and 28,6% (20/70) in the control group. Spanish study group had the same kind of results in their retrospective cohort; IH rate of 5,9% (3/50) in the mesh group and 33,3% (33/100) in the control group. There was no statistically significant difference in the incidence of surgical site infection or other complications when prophylactic mesh group was compared to standard closure group. SSI rate in Swiss study was 60% and respectively only 17% in the Spanish study. This may reflect differences in the patient selection, therefore the safety profile of the prophylactic mesh in the emergency setting has not been adequately described. Neither of the studies included in meta-analysis were not randomized controlled trials. There were also many methodological differences including patient selection, used mesh, and mesh placement. Thus, the conclusion of the systematic review paper was that there are limited data to assess the effect or safety of the use of prophylactic mesh in the emergency laparotomy setting. Randomized control trials are required to address this important clinical question. EHS guideline group resulted the same conclusion in their recommendation report.
There are about 1650 patients are operated in Finland because of IH every year. According to the European study, the estimated cost for IH surgery is 6450 euros. The corresponding costs in Sweden were even higher reaching 9060 euros per treatment. Extrapolated to Finland, this means that operative treatment of IHs cause more than 10 million expenses to the Finnish health care sector in a year. Some of these costs may be avoidable by using the prophylactic mesh during the closure of midline emergency laparotomies in the patients with IH risk factors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia, Emergency Laparotomy, Midline Laparotomy, Hernia Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Prophylactic self gripping mesh (Program, Medtronic) will be placed in rectorectus space to prevent incisional hernia.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Abdomen of the patients in the control group will be closed by using small stitch closure with suture to wound length of 4:1 and slowly absorbable monofilament suture.
Intervention Type
Device
Intervention Name(s)
Prophylactic self gripping mesh
Intervention Description
Prophylactic self gripping mesh, Propgrip by Medtronic.
Intervention Type
Device
Intervention Name(s)
Slowly absorbable continuous monofilament suture
Intervention Description
Fascial closure by continuous slowly absorbable 4:1 suture
Primary Outcome Measure Information:
Title
Incidence of incisional hernia
Description
Incidence of incisional hernia, either symptomatic or asymptomatic detected clinically and/or radiologically
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Comprehensive Complication Index
Description
Comprehensive Complication Index
Time Frame
30 days
Title
Surgical site infection (SSI) rate
Description
Surgical site infection (SSI) rate defined by CDC classification of surgical site infection
Time Frame
30 days
Title
Fascial rupture
Description
Incidence of fascial rupture
Time Frame
30 days
Title
Incisional hernia
Description
Incisional hernia incidence during long-term follow-up
Time Frame
5 years
Title
Incisional hernia repair rate
Description
Incisional hernia repair rate during follow-up
Time Frame
5 years
Title
Re-operations
Description
Re-operations due to mesh- or hernia related indications
Time Frame
5 years
Title
Quality of life by RAND-36
Description
Quality of life defined by RAND-36
Time Frame
5 years
Title
Quality of life by Promis
Description
Quality of life defined by Promis questionnaire
Time Frame
5 years
Title
Quality of life by AAS
Description
Quality of life defined by AAS questionnaire
Time Frame
5 years
Title
Cost analysis
Description
All differences in costs between the groups will be analyzed
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Midline emergency laparotomy for any gastrointestinal indication
Exclusion Criteria:
• Previous ventral hernia repair with mesh in the midline
Previous inguinal or femoral hernia repair by any technique with mesh is accepted
Previous WHO class of physical activity 3-4 (WHO 3 more than 50% of time at rest, WHO 4 stays at rest most of the time)
Relaparotomy
Indication for laparotomy is incarcerated hernia
Pregnant or suspected pregnancy
<18 years
Metastastic malignancy of any origin
Planned osteomyelitis
Patients living geographically distant and/or unwilling to return for follow-ups
No informed consent
Subject participates in another RCT Intra-operative exclusion criteria applicable for both randomization groups
Abdomen is left open
Second look laparotomy planned
Ostomy created at the operation
Inability to keep the mesh securely out of the peritoneal cavity or close the anterior fascia
Intra-abdominal malignancy diagnosed at the operation
>2 cm hernia in midline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa Mäkäräinen-Uhlbäck, M.D.
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jorvi Hospital
City
Espoo
Country
Finland
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Lahti Central Hospital
City
Lahti
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Seinäjoki Central Hospital
City
Seinäjoki
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
35143628
Citation
Makarainen E, Tolonen M, Sallinen V, Mentula P, Leppaniemi A, Ahonen-Siirtola M, Saarnio J, Ohtonen P, Muysoms F, Rautio T. Prophylactic retrorectus mesh versus no mesh in midline emergency laparotomy closure for prevention of incisional hernia (PREEMER): study protocol for a multicentre, double-blinded, randomized controlled trial. BJS Open. 2022 Jan 6;6(1):zrab142. doi: 10.1093/bjsopen/zrab142.
Results Reference
derived
Learn more about this trial
Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for Prevention of Incisional Hernia: a Multi Center, Double-blind, Randomized Controlled Trial
We'll reach out to this number within 24 hrs