Algorithm for Prophylactic Mesh Use in Emergency Laparotomy.

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

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

Study Overview

• Status: Recruiting
• Conditions: Incisional Hernia of Midline of Abdomen
• Intervention / Treatment: Procedure: Prophylactic mesh implantation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alejandro Bravo-Salva, M.D.; Phone Number: +34932483204; Email: abravo@psmar.cat

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08911
      • Recruiting
      • Hospital Del Mar
      • Contact: Alejandro Bravo-Salva, M.D.; Phone Number: +34932483204; Email: abravo@psmar.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Prophylactic mesh implantation; Use of an algorithm for prophylactic mesh implantation in high risk patients after emergency midline laparotomy.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global rate of complication.	Any postoperative complication will be recorded and classified using Clavien-Dindo scale.	Durign first month of postoperative follow up.
Reintervention	A second or subsequent intervention quotations due to postoperative comlications.	During first postoperative month follow up.
Hospital readmission	Patient admission to a hospital within 30 days after being discharged from an earlier hospital stay	During first postoperative month follow up.

Collaborators and Investigators

• Sponsor: Hospital del Mar

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: CEIC2019/8240/I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No