Hernia-Prophylaxis in Acute Care Surgery H-PACS (H-PACS)
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|ClinicalTrials.gov Identifier: NCT03090022|
Recruitment Status : Active, not recruiting
First Posted : March 24, 2017
Last Update Posted : June 24, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Active Comparator: Mesh implantation
Prior to closure of the abdominal wall a mesh will be implanted in a standardized fashion
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
- Number of incidence of death [ Time Frame: up to 18 months ]follow-up
- Number of patients with hernia free survival [ Time Frame: up to 18 months ]follow-up
- Number of patients with postoperative fascial dehiscence [ Time Frame: 30 days ]follow-up
- Number of postoperative mortality [ Time Frame: 90 days ]survival
- Number of surgical site infections postoperative [ Time Frame: 30 days ]follow-up
- Number of postoperative intestinal fistulas [ Time Frame: 30 days ]follow-up
- Number of small bowel obstructions [ Time Frame: 18 months ]follow-up
- Number of patients with postoperative pain [ Time Frame: 18 months ]follow-up
- Number of postoperative mesh infections [ Time Frame: 18 months ]follow-up
- Number of postoperative mesh explantations [ Time Frame: 18 months ]follow-up
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
|Dep. of Visceral and transplant surgery, Berne University Hospital|
|Berne, Switzerland, 3010|
|Principal Investigator:||Guido Beldi, Prof. Dr.||Inselspital Berne|