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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04578561
Other study ID # 20198240I
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2010
Est. completion date January 2020

Study information

Verified date October 2020
Source Hospital del Mar
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Observational Study analyzing the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.


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.


Recruitment information / eligibility

Status Completed
Enrollment 187
Est. completion date January 2020
Est. primary completion date January 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing emergency midline laparotomy

Exclusion Criteria:

- Those with need of concomitant hernia repair.

- Those who received incisions outside the midline.

- Those with delayed abdominal closure.

- Those who died in the immediate postoperative period.

- Those without a minimum 2 years of follow-up.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Prophylactic mesh use
After laparotomy sutured clousur the abdominal wall wound is reinforced using a suprafascial synthetic mesh.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
José A. Pereira

Outcome

Type Measure Description Time frame Safety issue
Primary Incisional hernia Detection of clinical or subclinical incisional hernia during postoperative longterm followup 2 years