Incisional Hernia of Midline of Abdomen
Conditions
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.
Interventions
PROCEDUREProphylactic mesh implantation
Use of an algorithm for prophylactic mesh implantation in high risk patients after emergency midline laparotomy.
Sponsors
Hospital del Mar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients with emergency surgery using midline laparotomy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional hernia | Durign first and second year of follow up | Diagnosis by clinical or image control of incicionsal hernia during follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence os surgical site ocurrence complications | During 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Global rate of complication. | Durign first month of postoperative follow up. | Any postoperative complication will be recorded and classified using Clavien-Dindo scale. |
| Reintervention | During first postoperative month follow up. | A second or subsequent intervention quotations due to postoperative comlications. |
| Hospital readmission | During first postoperative month follow up. | Patient admission to a hospital within 30 days after being discharged from an earlier hospital stay |
Countries
Spain
Contacts
Primary ContactAlejandro Bravo-Salva, M.D.
Outcome results
None listed