search
Back to results

Algorithm for Prophylactic Mesh Use in Emergency Laparotomy.

Primary Purpose

Incisional Hernia of Midline of Abdomen

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Prophylactic mesh implantation
Sponsored by
Hospital del Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incisional Hernia of Midline of Abdomen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital del MarRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Algorithm use for prphylactic mesh after emergency laparotomy

Arm Description

Patients with emergency surgery in whom algorithm for prophylactic mesh is use to help decide abdominal wall mesh reinforcement or not.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 15, 2021
Last Updated
March 18, 2021
Sponsor
Hospital del Mar
search

1. Study Identification

Unique Protocol Identification Number
NCT04808063
Brief Title
Algorithm for Prophylactic Mesh Use in Emergency Laparotomy.
Official Title
Prevention of Incisional Hernia in Emergent Laparotomy Using a Prophylactic Mesh Augmentation Protocol Algorithm.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Mar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia of Midline of Abdomen

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with emergency surgery using midline laparotomy
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Algorithm use for prphylactic mesh after emergency laparotomy
Arm Type
Experimental
Arm Description
Patients with emergency surgery in whom algorithm for prophylactic mesh is use to help decide abdominal wall mesh reinforcement or not.
Intervention Type
Procedure
Intervention Name(s)
Prophylactic mesh implantation
Intervention Description
Use of an algorithm for prophylactic mesh implantation in high risk patients after emergency midline laparotomy.
Primary Outcome Measure Information:
Title
Incisional hernia
Description
Diagnosis by clinical or image control of incicionsal hernia during follow up.
Time Frame
Durign first and second year of follow up
Secondary Outcome Measure Information:
Title
Incidence os surgical site ocurrence complications
Description
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.
Time Frame
During first postoperative month.
Title
Long term mesh related complications: chronic pain and mesh infection.
Description
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.
Time Frame
During first year of follow-up.
Other Pre-specified Outcome Measures:
Title
Global rate of complication.
Description
Any postoperative complication will be recorded and classified using Clavien-Dindo scale.
Time Frame
Durign first month of postoperative follow up.
Title
Reintervention
Description
A second or subsequent intervention quotations due to postoperative comlications.
Time Frame
During first postoperative month follow up.
Title
Hospital readmission
Description
Patient admission to a hospital within 30 days after being discharged from an earlier hospital stay
Time Frame
During first postoperative month follow up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Bravo-Salva, M.D.
Phone
+34932483204
Email
abravo@psmar.cat
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08911
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Bravo-Salva, M.D.
Phone
+34932483204
Email
abravo@psmar.cat

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Algorithm for Prophylactic Mesh Use in Emergency Laparotomy.

We'll reach out to this number within 24 hrs