Colorectal Cancer, Hernia Incisional, Wound Infection
Conditions
Keywords
Colorectal cancer, Wound Infection, Hernia Incisional, Mesh, Polypropylene, PVDF
Brief summary
In the latest guidelines for abdominal wall closure in emergency surgery published in the World Journal of Emergency Surgery (WJES) in 2023, no specific recommendations are made in this regard. Current literature does not provide any articles comparing these two types of mesh materials (PP vs PVDF) in emergency colorectal surgery. It is necessary to conduct a study comparing these two types of mesh materials, specifically in high-risk patients for incisional hernia and emergency colorectal surgery. This study aims to contribute to generating evidence regarding differences in wound infection incidence and potential subsequent complications, such as chronic pain. It is essential to conduct a study comparing different methods of laparotomy closure, specifically in emergency colorectal surgery, to contribute valuable evidence regarding the incidence of incisional hernia and potential subsequent complications.
Interventions
COMBINATION_PRODUCTPolyvinylidene fluoride mesh
Midline laparotomy closure using the small bites technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh.
COMBINATION_PRODUCTProphylactic polypropylene mesh
Midline laparotomy closure using the small bites technique associated with a prophylactic suprafascial polypropylene mesh.
Sponsors
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients meeting the inclusion criteria for the study will be randomized 1:1 using random number generation functions with SPSS v.21 software into either the PP or PVDF group. This randomization will be carried out using sealed opaque envelopes at the time immediately preceding the onset of the surgical intervention within the operating room. The envelope will be opened within the operating room once the closure of the midline laparotomy is initiated.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with colorectal pathology requiring urgent surgical treatment via midline laparotomy. * Patients undergoing urgent laparoscopic surgery but requiring conversion to midline laparotomy. * Need for urgent surgical treatment involving the colon and/or rectum, even in the presence of other abdominal pathologies. * Age over 18 years. * Signed informed consent (IC) from both the patient and the investigator * Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD. * BMI ≥ 35 kg/m2. * Re-laparotomies.
Exclusion criteria
* Patients with psychiatric illnesses, addictions, or any disorder hindering the understanding of the Informed Consent. * Inability to read or comprehend any of the languages in the Informed Consent (Catalan, Spanish).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgical wound infection | 30 postoperative days | Compare the incidence of surgical wound infection between the two groups: Closure of midline laparotomy using the small bites technique associated with a suprafascial polypropylene mesh versus closure of midline laparotomy using the small bites technique associated with a suprafascial polyvinylidene fluoride mesh. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of incisional hernia | One year surgery | Compare the rate of incisional hernia at one year post-surgery, postoperative complications, and abdominal pain at 6 and 12 months in both groups. Also, compare the rates of parastomal hernias. |
| Morbidity and mortality rates | 90 postoperative days | Comparison between the two groups on various aspects related to postoperative morbidity and mortality. Other aspects to be evaluated include the time of initiation of tolerance to solid oral diet, onset of ambulation, presence of anastomotic dehiscence, need for reinterventions, and occurrence of complications according to the Clavien-Dindo classification at 30 and 90 days, as well as the mortality rate at 90 days. Additionally, the aim is to compare the rate of initiation of adjuvant treatment within the first 6 weeks post-surgery, if indicated. |
Countries
Spain
Contacts
Primary ContactFrank Fernández, Dr.
Outcome results
None listed