Clinical trial NCT06501508: Abdominal Wall Dehiscence After Laparotomy Closure in Abdominal Surgery: a Retrospective Observational Study on the Influence of the Suture Used
Official title: Abdominal Wall Dehiscence After Laparotomy Closure in Abdominal Surgery: a Retrospective Observational Study on the Influence of the Suture Used
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgical Wound Dehiscence
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2024-07-15
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults over 18 years of age operated via laparotomy or laparoscopy with extraction site incision in the 4 participating Hospitals between 01/01/2018 and 21/11/23

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, ICD9/ICD10 codes are also used. Following the AHQR definition, cases of laparotomy dehiscence will be defined as those whose ICD 9/ICD 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.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years, abdominal incision or laparoscopy with extraction site incision

Exclusion Criteria:

* Pregnancy, use of mesh for fascial closure in primary surgery, history of ventral abdominal hernia surgery

Primary outcomes:
measure: Abdominal Wall Dehiscence
timeFrame: 30 days
Secondary outcomes:
measure: Incisional hernia
timeFrame: 1 year
measure: PROMs - Postoperative Pain
timeFrame: 1 year
measure: PROMs - Mental and emotional health
timeFrame: 1 year
measure: PROMs - Work an social life performance
timeFrame: 1 year
measure: PROMs - Fatigue
timeFrame: 1 year
measure: PROMs - Funcionality
timeFrame: 1 year
measure: PROMs - Sexuality
timeFrame: 1 year
measure: PROMs - Body image
timeFrame: 1 year
Other outcomes:
Locations:
city: Collado-Villalba
country: Spain
facility: Hospital universitario General de Villalba
state: Madrid
city: Valdemoro
country: Spain
facility: Hospital Universitario Infanta Elena
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario Rey Juan Carlos
Study officials:
affiliation: Quironsalud
name: Hector Gauadalajara Labajo, PHD
role: PRINCIPAL_INVESTIGATOR
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