Algorithm for Prophylactic Mesh Use in Emergency Laparotomy.

NCT ID: NCT04808063

Last Updated: 2021-03-19

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Incisional Hernia of Midline of Abdomen

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients with emergency surgery using midline laparotomy
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Algorithm use for prphylactic mesh after emergency laparotomy

Patients with emergency surgery in whom algorithm for prophylactic mesh is use to help decide abdominal wall mesh reinforcement or not.

Group Type EXPERIMENTAL

Prophylactic mesh implantation

Intervention Type PROCEDURE

Use of an algorithm for prophylactic mesh implantation in high risk patients after emergency midline laparotomy.

Interventions

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Prophylactic mesh implantation

Use of an algorithm for prophylactic mesh implantation in high risk patients after emergency midline laparotomy.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital del Mar

OTHER

Sponsor Role lead

Responsible Party

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Alejandro Bravo Salva

Assistant doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital del Mar

Barcelona, Catalonia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Alejandro Bravo-Salva, M.D.

Role: CONTACT

+34932483204

Facility Contacts

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Alejandro Bravo-Salva, M.D.

Role: primary

+34932483204

Other Identifiers

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CEIC2019/8240/I

Identifier Type: -

Identifier Source: org_study_id

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