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OpenTrials
Completed

NCT Number: NCT03090022

Hernia-Prophylaxis in Acute Care Surgery H-PACS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. of Visceral and transplant surgery, Berne University Hospital

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strattice

Procedure

Intra-abdominally Fixation

Other names: Acellular porcine dermal mesh

Single running suture of abdominal fascia

Procedure

Intra-abdominal suture

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Prophylactic Mesh Implantation in Patients Undergoing Requiring Emergency Laparatomy for the Prevention of Incisional Hernia:A Randomized Controlled Trial

Acronym: H-PACS

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2017
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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