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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03090022
Other study ID # 2016-02212
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date October 5, 2020

Study information

Verified date October 2021
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population. Patients requiring emergency laparotomy are at high risk for the development of incisional hernia and fascial dehiscence. Among this population the incidence of incisional hernia in patients undergoing emergency surgery varies between 33-54%. Incisional hernias are associated with a high morbidity rate, such as intestinal incarceration, chronic discomfort, pain, and reoperation and typically require implantation of a synthetic mesh in a later second operation. Fascial dehiscence represents an acute form of dehiscence and has been observed in up to 24.1% and is associated with a mortality rate up to 44%. The gold standard for abdominal wall closure during elective and emergency operations is a running slowly absorbable suture. In the elective situation it has been shown that prophylactic mesh implantation in high risk patients reduced the incidence of incisional hernia significantly. The investigators and others have shown that mesh implantation in patients undergoing emergency laparotomy or in contaminated abdominal cavities are safe . With a randomized controlled trial the investigators now aim to compare the incidence of incisional hernia after prophylactic mesh implantation versus standard of care in patients requiring emergency laparotomy.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date October 5, 2020
Est. primary completion date October 5, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing emergency midline laparatomy - Emergency laparoscopy with expected conversion to midline laparatomy - Written informed consent Exclusion Criteria: - ASA =5 - Septic shock - Pregnant women - Prior mesh Implantation - Known sensitivity for porcine material or Polysorbate 20

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Strattice
Intra-abdominally Fixation
Single running suture of abdominal fascia
Intra-abdominal suture

Locations

Country Name City State
Switzerland Dep. of Visceral and transplant surgery, Berne University Hospital Berne

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of incidence of death follow-up up to 18 months
Primary Number of patients with hernia free survival follow-up up to 18 months
Secondary Number of patients with postoperative fascial dehiscence follow-up 30 days
Secondary Number of postoperative mortality survival 90 days
Secondary Number of surgical site infections postoperative follow-up 30 days
Secondary Number of postoperative intestinal fistulas follow-up 30 days
Secondary Number of small bowel obstructions follow-up 18 months
Secondary Number of patients with postoperative pain follow-up 18 months
Secondary Number of postoperative mesh infections follow-up 18 months
Secondary Number of postoperative mesh explantations follow-up 18 months
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