Abdominal Wall Dehiscence After Laparotomy Closure in Abdominal Surgery: a Retrospective Observational Study on the Influence of the Suture Used (SUTURA)

July 9, 2024 updated by: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Marius Kaser, Dr.
  • Phone Number: 0034652174951

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Miguel Leon Arellano
        • Sub-Investigator:
          • Marius Kaeser
        • Principal Investigator:
          • Hector Guadalajara
        • Sub-Investigator:
          • Montiell Jimenez Fuertes
        • Sub-Investigator:
          • Maria Dolores Martín Rios
      • Madrid, Spain, 28933
        • Recruiting
        • Hospital Universitario Rey Juan Carlos
        • Contact:
          • Hector Guadalajara
          • Phone Number: 0034649429243
        • Sub-Investigator:
          • Maria Belen Manso Abajo
    • Madrid
      • Collado-Villalba, Madrid, Spain, 28400
        • Recruiting
        • Hospital Universitario General de Villalba
        • Contact:
          • Hector Guadalajara Labajo
          • Phone Number: 0034649429243
        • Sub-Investigator:
          • María José Fraile Vilarrasa
      • Valdemoro, Madrid, Spain, 28342
        • Recruiting
        • Hospital Universitario Infanta Elena
        • Contact:
          • Hecotr Guadalajara Labajo
        • Sub-Investigator:
          • Santos Jiménez de los Galanes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stratafix
All patients in which Stratafix symmetric was used for the primary closure of the abdominal wall incision
Device: Stratafix Symmetric
Use of Stratafix Symmetric for primary fascial closure
Control
All patients in which other, conventional suture types were used for primary closure of the abdominal wall incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal Wall Dehiscence
Time Frame: 30 days
Disruption of all layers of the abdominal wall with exposure of abdominal viscera within 30 days after primary surgery
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incisional hernia
Time Frame: 1 year
Any defect of the abdominal wall in the area of the primary incision, palpable or visible in ultrasound, CT- or MR-Scan, with or without protrusion of intraabdominal content
1 year
PROMs - Postoperative Pain
Time Frame: 1 year
One question about pain - 4 answers
1 year
PROMs - Mental and emotional health
Time Frame: 1 year
Two questions - 4 answers for each question
1 year
PROMs - Work an social life performance
Time Frame: 1 year
Two questions - 4 answers for each question
1 year
PROMs - Fatigue
Time Frame: 1 year
Two questions - 4 answers for each question
1 year
PROMs - Funcionality
Time Frame: 1 year
One question - 4 answers for each question
1 year
PROMs - Sexuality
Time Frame: 1 year
One question - 4 answers for each question
1 year
PROMs - Body image
Time Frame: 1 year
One question - 4 answers for each question
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Collaborators

Ethicon, Inc.

Investigators

  • Principal Investigator: Hector Gauadalajara Labajo, PHD, Quironsalud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2023

Primary Completion (Estimated)

November 22, 2024

Study Completion (Estimated)

November 22, 2024

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIC089-23_FJD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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