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Algorithm for Prophylactic Mesh Use in Emergency Laparotomy.

H

Hospital del Mar

Status

Unknown

Conditions

Incisional Hernia of Midline of Abdomen

Treatments

Procedure: Prophylactic mesh implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT04808063
CEIC2019/8240/I

Details and patient eligibility

About

Use of informed algorithm for patients selection of prophylactic mesh aplication after midline laparotomy in emergency surgery.

Full description

Midline laparotomy complications have a high rate. When midline laparotomy is performed complications rate is even higher. One of the commons complications is incisional hernia, reaching up to 40%- 50% of cases in High risk groups.

Prophylactic mesh use has been proved to be useful preventing midline laparotomy in elective surgery. Despite this, there is not enough data to recommend its use in emergency surgery.

Aim of the study is to investigate if use of an algorithm of informed decision for use of prophylactic mesh in emergency midline laparotomy reduces incisional hernia incidence.

Prospective cohort study of all consecutive midline laparotomy performed at our emergency surgery department. Compare correct application of algorithm outcomes versus non correct application.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Emergency midline laparotomy.

Exclusion criteria

  • Surgical infection present at the moment of surgery.
  • Ventrla or incisional hernia present at the moment of laparotomy .
  • Open abdomen.
  • Preoperative American Society of Anesthesiologist score (ASA) of V.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Algorithm use for prphylactic mesh after emergency laparotomy
Experimental group
Description:
Patients with emergency surgery in whom algorithm for prophylactic mesh is use to help decide abdominal wall mesh reinforcement or not.
Treatment:
Procedure: Prophylactic mesh implantation

Trial contacts and locations

1

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Central trial contact

Alejandro Bravo-Salva, M.D.

Data sourced from clinicaltrials.gov

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