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Algorithm for Prophylactic Mesh Use in Emergency Laparotomy.

Not Applicable
Conditions
Incisional Hernia of Midline of Abdomen
Interventions
Procedure: Prophylactic mesh implantation
Registration Number
NCT04808063
Lead Sponsor
Hospital del Mar
Brief Summary

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

Detailed 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Emergency midline laparotomy.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Algorithm use for prphylactic mesh after emergency laparotomyProphylactic mesh implantationPatients with emergency surgery in whom algorithm for prophylactic mesh is use to help decide abdominal wall mesh reinforcement or not.
Primary Outcome Measures
NameTimeMethod
Incisional herniaDurign first and second year of follow up

Diagnosis by clinical or image control of incicionsal hernia during follow up.

Secondary Outcome Measures
NameTimeMethod
Long term mesh related complications: chronic pain and mesh infection.During first year of follow-up.

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.

Incidence os surgical site ocurrence complicationsDuring first postoperative month.

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.

Trial Locations

Locations (1)

Hospital del Mar

🇪🇸

Barcelona, Catalonia, Spain

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