Surgery Clinical Trial
Official title:
Prophylactic Mesh Implantation in Patients With Peritonitis for the Prevention of Incisional Hernia: A Randomized Controlled Trial
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
Enrolling by invitation |
NCT05534490 -
Surgery and Functionality in Older Adults
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Terminated |
NCT04612491 -
Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
|
||
Recruiting |
NCT06397287 -
PROM Project Urology
|
||
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT03432429 -
Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
|
||
Completed |
NCT04176822 -
Designing Animated Movie for Preoperative Period
|
N/A | |
Recruiting |
NCT05370404 -
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
|
N/A | |
Not yet recruiting |
NCT05467319 -
Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS
|
Phase 3 | |
Recruiting |
NCT04602429 -
Children's Acute Surgical Abdomen Programme
|
||
Completed |
NCT03124901 -
Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor
|
N/A | |
Completed |
NCT04595695 -
The Effect of Clear Masks in Improving Patient Relationships
|
N/A | |
Recruiting |
NCT06103136 -
Maestro 1.0 Post-Market Registry
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Completed |
NCT04059328 -
Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
|
||
Recruiting |
NCT03697278 -
Monitoring Postoperative Patient-controlled Analgesia (PCA)
|
N/A |