Algorithm for Prophylactic Mesh Use in Emergency Laparotomy.

Study Overview
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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.

Official Title
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Prevention of Incisional Hernia in Emergent Laparotomy Using a Prophylactic Mesh Augmentation Protocol Algorithm.

Conditions
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Incisional Hernia of Midline of Abdomen

Intervention / Treatment
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* Procedure: Prophylactic mesh implantation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with emergency surgery using midline laparotomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Algorithm use for prphylactic mesh after emergency laparotomy<br>Patients with emergency surgery in whom algorithm for prophylactic mesh is use to help decide abdominal wall mesh reinforcement or not. | Procedure: Prophylactic mesh implantation<br>* Use of an algorithm for prophylactic mesh implantation in high risk patients after emergency midline laparotomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional hernia | Diagnosis by clinical or image control of incicionsal hernia during follow up. | Durign first and second year of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence os surgical site ocurrence complications | Any surgical site ocurrence (SSO) complication will be registered and classified using Clavien-Dindo complication scale. More common complications are: Seroma: a localized accumulation of serous fluid in a part of the body, occurring most commonly as a complication of a surgical procedure. Wound haemathoma: wound related swelling of blood. Surgical site infection: infection that occurs after surgery in the part of the body where the surgery took place. Will be classified as superficial or deep infection. Wound dehiscence: lack of cutaneous healing in surgical wound. | During first postoperative month. | 
| Long term mesh related complications: chronic pain and mesh infection. | Chronic pain: is any pain which persists beyond the normal healing period of 12 weeks. Visual analoge scale will be used to measure it. Mesh infection: Late-onset mesh infection is defined as acute inflammatory response in surgical area within months or years after operation. It is diagnosed by the presence of infection symptoms and imaging examinations. | During first year of follow-up. |