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Hernia-Prophylaxis in Acute Care Surgery H-PACS (H-PACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03090022
Recruitment Status : Active, not recruiting
First Posted : March 24, 2017
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief 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.


Condition or disease Intervention/treatment Phase
Incisional Hernia Procedure: Strattice Procedure: Single running suture of abdominal fascia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Prophylactic Mesh Implantation in Patients Undergoing Requiring Emergency Laparatomy for the Prevention of Incisional Hernia:A Randomized Controlled Trial
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Mesh implantation
Prior to closure of the abdominal wall a mesh will be implanted in a standardized fashion
Procedure: Strattice
Intra-abdominally Fixation
Other Name: Acellular porcine dermal mesh

Active Comparator: Single running suture of abdominal fascia
The closure of the abdominal wall a Standard technique will be applied using a running suture
Procedure: Single running suture of abdominal fascia
Intra-abdominal suture




Primary Outcome Measures :
  1. Number of incidence of death [ Time Frame: up to 18 months ]
    follow-up

  2. Number of patients with hernia free survival [ Time Frame: up to 18 months ]
    follow-up


Secondary Outcome Measures :
  1. Number of patients with postoperative fascial dehiscence [ Time Frame: 30 days ]
    follow-up

  2. Number of postoperative mortality [ Time Frame: 90 days ]
    survival

  3. Number of surgical site infections postoperative [ Time Frame: 30 days ]
    follow-up

  4. Number of postoperative intestinal fistulas [ Time Frame: 30 days ]
    follow-up

  5. Number of small bowel obstructions [ Time Frame: 18 months ]
    follow-up

  6. Number of patients with postoperative pain [ Time Frame: 18 months ]
    follow-up

  7. Number of postoperative mesh infections [ Time Frame: 18 months ]
    follow-up

  8. Number of postoperative mesh explantations [ Time Frame: 18 months ]
    follow-up



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090022


Locations
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Switzerland
Dep. of Visceral and transplant surgery, Berne University Hospital
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Guido Beldi, Prof. Dr. Inselspital Berne

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03090022     History of Changes
Other Study ID Numbers: 2016-02212
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes