Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02012270
Status:
COMPLETED
Last Update Posted:
2018-04-10
First Post:
2013-12-10
Brief Title:
Aneurysma Hernia Study - Incidence of Incisional Hernias After Abdominal Aortic Aneurysm Repair
Sponsor:
Igor Koncar
Organization:
University of Belgrade
Study Overview
Official Title:
Prospective Case-control Study on the Incidence of Incisional Hernias at 12 Months After Closure of Midline Laparotomies in Patients Treated for Abdominal Aortic Aneurysm
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
АНЕУРИЗМА
Brief Summary:
Principles Prevention of incision hernias by primary closure of mid line laparotomies with the best-evidenced suture techniques
Background
Surgical practice of abdominal wall closure continues to rely largely on tradition rather than high-quality level I evidence Incisional hernia after laparotomy for treatment of abdominal aortic aneurysm AAA has a high incidence
At this moment the best results in a prospective randomised clinical trial considering incision hernia rates and wound infections have been reported by the surgeons from the Sundsvall clinic in Sweden Their technique using a suture to wound length ratio of at least 41 and using many small stitches will be described in the protocol as the Principles Technique We want to explore if these results can indeed prevent incision hernias significantly if implemented with training and tutoring
MethodologyVascular surgeonswho are not using the principles yet but show an interest to learn the Principles will be asked to monitor a cohort of AAA patients using their current sutures and surgical techniques Some of the vascular surgeons will undergo training and if wanted proctoring during the first procedures using the Principles A cohort of 120 AAA patients will be closed according to the Principles and monitored The results of these 120 patients will be compared to the control group consisting of patients closed with the conventional technique by non---trained surgeons Primary endpointThe incidence of incision hernias at 12 months will be determined by clinical examination
Data management and ownership
The data will be collected on a paper form and will be introduced is a database SPSS Statistics IBM from which statistical analysis will be made
Background
Surgical practice of abdominal wall closure continues to rely largely on tradition rather than high-quality level I evidence Incisional hernia after laparotomy for treatment of abdominal aortic aneurysm AAA has a high incidence
At this moment the best results in a prospective randomised clinical trial considering incision hernia rates and wound infections have been reported by the surgeons from the Sundsvall clinic in Sweden Their technique using a suture to wound length ratio of at least 41 and using many small stitches will be described in the protocol as the Principles Technique We want to explore if these results can indeed prevent incision hernias significantly if implemented with training and tutoring
MethodologyVascular surgeonswho are not using the principles yet but show an interest to learn the Principles will be asked to monitor a cohort of AAA patients using their current sutures and surgical techniques Some of the vascular surgeons will undergo training and if wanted proctoring during the first procedures using the Principles A cohort of 120 AAA patients will be closed according to the Principles and monitored The results of these 120 patients will be compared to the control group consisting of patients closed with the conventional technique by non---trained surgeons Primary endpointThe incidence of incision hernias at 12 months will be determined by clinical examination
Data management and ownership
The data will be collected on a paper form and will be introduced is a database SPSS Statistics IBM from which statistical analysis will be made
Detailed Description:
Principles Prevention of incision hernias by primary closure of mid line laparotomies with the best-evidenced suture techniques
Background
Although many data from prospective studies have set some evidence-based principles to be adopted when closing mid line laparotomy incisions these principles have not found a widespread implementation in the surgical community Surgical practice continues to rely largely on tradition rather than high-quality level I evidence Incision hernia after laparotomy for treatment of abdominal aortic aneurysm AAA has a high incidence of 10 to 37 depending on the method of follow up clinically with ultrasound or with CT scan and the duration of follow up
It is known that the surgical technique used to close the fascia in mid line laparotomies is an important parameter with regard to wound complications like wound infections and incision hernias At this moment the best results in a prospective randomised clinical trial considering incisional hernia rates and wound infections have been reported by the surgeons from the Sundsvall clinic in Sweden Their technique using a suture to wound length ratio of at least 41 and using many small stitches will be described in the protocol as the Principles Technique We want to explore if these results can indeed prevent incision hernias significantly if implemented with training and tutoring
MethodologyVascular surgeonswho are not using the principles yet but show an interest to learn the Principles will be asked to monitor a cohort of AAA patients using their current sutures and surgical techniques Some of the vascular surgeons will undergo training and if wanted proctoring during the first procedures using the Principles A cohort of 120 AAA patients will be closed according to the Principles and monitored The results of these 120 patients will be compared to the control group consisting of patients closed with the conventional technique by non---trained surgeons Study hypothesis and sample size calculation Investigators might improve the incision hernia rate after AAA treatment through a mid line incision at 12 months by using the Principles from an estimated 25 in the conventionally closed patients to 10 in the patients closed using the Principles
Calculation
To show a decrease of 60 in the incision hernia rate at 12 months25 vs 10 incision hernias at 12 monthswith a power of 80 and a significance level of 5 investigators need 100 evaluable patients at 12 months in each arm To compensate a 20 lost to follow up we have to include at least 120 patients before the principles training and 120 patients afterwards So the trial will end inclusions when 120 AAA patients have been entered using the Principles Most likely the control group will be larger than these 120 patientsdepending on the number of vascular surgeons participating in the teaching course and the timing of this course
Primary endpointThe incidence of incision hernias at 12 months will be determined by clinical examination
Data management and ownership
The data will be collected on a paper form and will be introduced in a database SPSS Statistics IBM from which statistical analysis will be made
Background
Although many data from prospective studies have set some evidence-based principles to be adopted when closing mid line laparotomy incisions these principles have not found a widespread implementation in the surgical community Surgical practice continues to rely largely on tradition rather than high-quality level I evidence Incision hernia after laparotomy for treatment of abdominal aortic aneurysm AAA has a high incidence of 10 to 37 depending on the method of follow up clinically with ultrasound or with CT scan and the duration of follow up
It is known that the surgical technique used to close the fascia in mid line laparotomies is an important parameter with regard to wound complications like wound infections and incision hernias At this moment the best results in a prospective randomised clinical trial considering incisional hernia rates and wound infections have been reported by the surgeons from the Sundsvall clinic in Sweden Their technique using a suture to wound length ratio of at least 41 and using many small stitches will be described in the protocol as the Principles Technique We want to explore if these results can indeed prevent incision hernias significantly if implemented with training and tutoring
MethodologyVascular surgeonswho are not using the principles yet but show an interest to learn the Principles will be asked to monitor a cohort of AAA patients using their current sutures and surgical techniques Some of the vascular surgeons will undergo training and if wanted proctoring during the first procedures using the Principles A cohort of 120 AAA patients will be closed according to the Principles and monitored The results of these 120 patients will be compared to the control group consisting of patients closed with the conventional technique by non---trained surgeons Study hypothesis and sample size calculation Investigators might improve the incision hernia rate after AAA treatment through a mid line incision at 12 months by using the Principles from an estimated 25 in the conventionally closed patients to 10 in the patients closed using the Principles
Calculation
To show a decrease of 60 in the incision hernia rate at 12 months25 vs 10 incision hernias at 12 monthswith a power of 80 and a significance level of 5 investigators need 100 evaluable patients at 12 months in each arm To compensate a 20 lost to follow up we have to include at least 120 patients before the principles training and 120 patients afterwards So the trial will end inclusions when 120 AAA patients have been entered using the Principles Most likely the control group will be larger than these 120 patientsdepending on the number of vascular surgeons participating in the teaching course and the timing of this course
Primary endpointThe incidence of incision hernias at 12 months will be determined by clinical examination
Data management and ownership
The data will be collected on a paper form and will be introduced in a database SPSS Statistics IBM from which statistical analysis will be made
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None