Algorithm for Prophylactic Mesh Use in Emergency Laparotomy.

Incisional Hernia of Midline of Abdomen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04808063
• Other study ID #: CEIC2019/8240/I
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Hospital del Mar
• Contact: Alejandro Bravo-Salva, M.D.
• Phone: +34932483204
• Email: abravo[@]psmar.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Incisional Hernia of Midline of Abdomen

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global rate of complication.	Any postoperative complication will be recorded and classified using Clavien-Dindo scale.	Durign first month of postoperative follow up.
Other	Reintervention	A second or subsequent intervention quotations due to postoperative comlications.	During first postoperative month follow up.
Other	Hospital readmission	Patient admission to a hospital within 30 days after being discharged from an earlier hospital stay	During first postoperative month follow up.
Primary	Incisional hernia	Diagnosis by clinical or image control of incicionsal hernia during follow up.	Durign first and second year of follow up
Secondary	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.
Secondary	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.