An interventional study of A non-absorbable composite mesh (Ethicon Physiomesh) in Peritonitis, Incisional Hernia and Surgery, sponsored by Insel Gruppe AG, University Hospital Bern. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-16.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Prevention
In patients undergoing laparotomy, the incidence of abdominal wall related complications such as incisional hernia is very high. In particular in patients with peritonitis undergoing laparotomy the incidence of incisional hernia is up to 54.3%. Furthermore, these patients are at great risk for development of postoperative fascial dehiscence.
The gold standard of abdominal wall closure is a running slowly absorbable suture irrespective of the presence of peritonitis. Implantation of an intraperitoneal mesh potentially reduces the incidence of incisional hernia.
In a series of high risk patients in which we implanted non-absorbable intraperitoneal mesh prophylactically we reduced the incidence of incisional hernia down to 3.2%.
Background
Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population [1,2]. An incisional hernia is defined as any abdominal wall gap with or without a bulge in the area of postoperative scar perceptible or palpable by clinical examination or imaging [3]. Overall incidence of incisional hernia at our institution with a follow-up of five years was 14%, whereas in patients undergoing liver transplantation we found an incidence of incisional hernia of 25% in a prospective study [2]. However, patients with peritonitis are at very high risk for the development of incisional hernia. Moussavian et al demonstrated an incidence of incisional hernia of 54.3% after a median follow-up of 6 years in patients undergoing emergency surgery for secondary peritonitis [4]. In patients undergoing surgical therapy for secondary peritonitis, redo surgery because of complications associated with the abdominal wall, such as fascial dehiscence and surgical site infection are frequent. Impaired wound healing in response to the systemic inflammatory response and the high incidence of surgical site infection might render the abdominal wall even more susceptible for incisional hernia, compared with the general surgical population [5,6]. Furthermore, patients with peritonitis undergoing emergency laparotomy develop fascial dehiscence in up to 24.1% [7]. Fascial dehiscence requires reoperation and is associated with a mortality rate up to 44% [8].
Objective
To compare prophylactic mesh implantation to conventional abdominal wall closure in patients undergoing emergency laparotomy for peritonitis.
Methods
Implantation of a non-resorbable intraperitoneal mesh in patients with peritonitis undergoing emergency laparotomy.
185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.
This study's enrollment of 5 is below the median of 95 across 118 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
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Exclusion Criteria
Conventional abdominal wall closure with mesh implantation
Device: A non-absorbable composite mesh (Ethicon Physiomesh)
Conventional abdominal wall closure without mesh implantation
To compare prophylactic mesh implantation to conventional abdominal wall closure in patients undergoing emergency laparotomy for peritonitis.
Number of patients with incisional hernia
Time frame: 54 months
Number of patients with facial dehiscence
Time frame: 54 months
Mortality
Time frame: 54 months
Number of patients with surgical site infection
Time frame: 54 months
Number of patients with intestinal fistula
Time frame: 54 months
Number of patients with small bowel obstruction
Time frame: 54 months
Number of patients with postoperative pain
Time frame: 54 months
Number of patients with low grade mesh infection or chronic subclinical inflammation
Time frame: 54 months
Number of patients with mesh explantation
Time frame: 54 months
This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern