Risk Factors of Incisional Hernias After Emergency Midline Laparotomy

NCT ID: NCT05509452

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-29

Study Completion Date

2027-03-31

Brief Summary

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The aim of this study is to identify risk factors for the development of incisional hernias in emergency midline laparotomies.

Detailed Description

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All patients operated with an emergency midline laparotomy and attending 1-year follow-up in our clinic is potential participants and will be screened for participation. Potential participants will be briefly informed about the project by the hospital staff. If the patients are interested, they will be thoroughly informed about the study and asked to participate by one of the trial investigators before discharge.

Data will be obtained from the participants hospital files and by patient survey/interview. All data will be entered into a database using RedCap by trial investigators or their delegates.

Enrolled patients will be followed for two years. The trial involves two clinical examinations and evaluations (one and two years) after surgery. Clinical examination involves interview with a standardized questionnaire and abdominal wall examination including inspection, palpation and ultrasound examination.

Conditions

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Incisional Hernia Emergency Midline Laparotomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age of 18 years or above and
* Unscheduled midline laparotomy in an emergency or subacute setting, involving perforated bowel, bowel obstruction, bowel ischemia (due to mesenteric vascular disease or incarceration), inflammatory diseases (e.g. diverticulitis, appendicitis, ulcerative colitis, cholecystitis and Crohn's disease), abscesses, non-traumatic intraabdominal bleeding and any emergency re-operation to elective surgery

Exclusion Criteria

* Age below 18 years
* Patients with mental or physical disorders making follow-up impossible
* Patients were no fascial closure is performed
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Madeline Kvist

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Gastrointestinal- and Hepatic diseases, Surgical Section,

Herlev, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Madeline Kvist, MB

Role: CONTACT

0045 38681410

Thomas K Jensen, MD

Role: CONTACT

0045 38681633

Other Identifiers

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HerlevH1

Identifier Type: -

Identifier Source: org_study_id

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