Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501508
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-11-22
Brief Title:
Abdominal Wall Dehiscence After Laparotomy Closure in Abdominal Surgery a Retrospective Observational Study on the Influence of the Suture Used
Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Organization:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study Overview
Official Title:
Abdominal Wall Dehiscence After Laparotomy Closure in Abdominal Surgery a Retrospective Observational Study on the Influence of the Suture Used
Status:
RECRUITING
Status Verified Date:
2023-11
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:
SUTURA
Brief Summary:
In this retrospective longitudinal observational study we compare the incidence of fascial dehiscence and incisional hernia in patients operated via abdominal wall incision comparing the barbed suture Stratafix Symmetric to other types of suture during closure of the abdominal wall In addition we plan to analize the impact of other risk factors patient related and patient unrelated on the incidence of fascial dehiscence
Detailed Description:
In this retrospective longitudinal observational study we primarily aim to compare the influence of the applied suture type Stratafix Symmetric versus other suture types for primary fascial closure in abdominal surgery on the incidence of fascial dehiscence
Secondary outcomes such as will also be analized Primary outcomeis the incidence of abdominal wall dehiscence Secondary outcomes are the impact of the occurrence of abdominal wall dehiscence on mortality and hospital stay the influence of other risk factors on the occurrence of abdominal wall dehiscence the influence of the suture type and other risk factors on the incidence of incisional hernia after 12 months of follow-up and a speciality subgroup analysis
The diagnoses of each patient and the procedures performed are coded according to ICD 9 or ICD 10 For primary cause diagnoses and secondary diagnoses external causes and procedures ICD9ICD10 codes are also used Following the AHQR definition cases of laparotomy dehiscence will be defined as those whose ICD 9ICD 10 codes conform to New closure of postoperative abdominal wall disruption as well as those identified secondarily after crossing the databases as reoperated for this reason with another coding
Statistical analysis will be performed using statistical techniques appropriate to the variables under study A descriptive analysis of the population will be performed frequency results will be expressed in absolute terms such as percentages and confidence intervals The percentage of subjects with dehiscence will be calculated by the group A two-sided 95 confidence interval CI for the difference in percentages Stratafix - Control will be estimated using the Wald method If the upper limit of the confidence interval for the difference in percentages Stratafix-Control is below 0 then it will be concluded that the true dehiscence rate for Stratafix is lower than that for the control In addition two-sided 95 CIs within each group will be estimated for the dehiscence rate using the Clopper-Pearson method
Continuous variables will be expressed as mean SD and median range according to the normality test Kolmogorov Smirnov test For the study of the relationship between the different variables Chi-square or Analysis of Variance will be used if they are parametric And if they do not follow a normal distribution nonparametric tests will be used Mann-Whitney U or Kruskal Wallis as appropriate Biochemical recurrence-free survival BCR-free survival will be estimated using Kaplan-Meier curves SPSS 21 SPSS Inc Chicago IL USA will be used
Secondary outcomes such as will also be analized Primary outcomeis the incidence of abdominal wall dehiscence Secondary outcomes are the impact of the occurrence of abdominal wall dehiscence on mortality and hospital stay the influence of other risk factors on the occurrence of abdominal wall dehiscence the influence of the suture type and other risk factors on the incidence of incisional hernia after 12 months of follow-up and a speciality subgroup analysis
The diagnoses of each patient and the procedures performed are coded according to ICD 9 or ICD 10 For primary cause diagnoses and secondary diagnoses external causes and procedures ICD9ICD10 codes are also used Following the AHQR definition cases of laparotomy dehiscence will be defined as those whose ICD 9ICD 10 codes conform to New closure of postoperative abdominal wall disruption as well as those identified secondarily after crossing the databases as reoperated for this reason with another coding
Statistical analysis will be performed using statistical techniques appropriate to the variables under study A descriptive analysis of the population will be performed frequency results will be expressed in absolute terms such as percentages and confidence intervals The percentage of subjects with dehiscence will be calculated by the group A two-sided 95 confidence interval CI for the difference in percentages Stratafix - Control will be estimated using the Wald method If the upper limit of the confidence interval for the difference in percentages Stratafix-Control is below 0 then it will be concluded that the true dehiscence rate for Stratafix is lower than that for the control In addition two-sided 95 CIs within each group will be estimated for the dehiscence rate using the Clopper-Pearson method
Continuous variables will be expressed as mean SD and median range according to the normality test Kolmogorov Smirnov test For the study of the relationship between the different variables Chi-square or Analysis of Variance will be used if they are parametric And if they do not follow a normal distribution nonparametric tests will be used Mann-Whitney U or Kruskal Wallis as appropriate Biochemical recurrence-free survival BCR-free survival will be estimated using Kaplan-Meier curves SPSS 21 SPSS Inc Chicago IL USA will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None