Viewing Study NCT04578561


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Study NCT ID: NCT04578561
Status: COMPLETED
Last Update Posted: 2020-10-08
First Post: 2020-10-05
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.
Sponsor: José A. Pereira
Organization:

Study Overview

Official Title: Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.
Status: COMPLETED
Status Verified Date: 2020-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Observational Study analyzing the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.
Detailed Description: Background. Prevention of incisional hernias with a prophylactic mesh in emergency surgery is controversial. The present study aimed to analyze the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.

Methods. This study was a retrospective analysis of patients who underwent an emergency midline laparotomy between January 2009 and July 2010 with a follow-up period of longer than 2 years. Long-term outcomes and risk factors for the development of incisional hernias between patients who received a prophylactic reinforcement mesh (Group M) and suture (Group S) were compared.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: