Colorectal Cancer, Incisional Hernia, Wound Infection
Conditions
Keywords
colorectal cancer, Hernia Incisional, Wound infection, small bites
Brief summary
The 2023 World Journal of Emergency Surgery guidelines couldn't provide a recommendation for emergency abdominal wall closure due to insufficient consensus (\>80% required). Available evidence, predominantly retrospective and heterogeneous, lacks differentiation between urgent and elective colorectal surgeries. Therefore, we advocate for a study comparing laparotomy closures in emergency colorectal surgery to contribute evidence on incisional hernia incidence and subsequent complications.
Interventions
PROCEDUREClosure of the midline laparotomy using the small bites technique
Closure of the midline laparotomy using the small bites technique will involve employing a monofilament polydioxanone suture with a gauge of 0 (PDS® II Ethicon, Bridgewater, NJ). No Redon drainage system will be left in the subcutaneous tissue.
PROCEDUREClosure of the midline laparotomy using the small bites technique with an absorbable PP mesh
Closure of the midline laparotomy using the small bites technique will involve employing a monofilament polydioxanone suture with a gauge of 0 (PDS® II Ethicon, Bridgewater, NJ). A partially absorbable low-density polypropylene suprapubic mesh (Ultrapro®, Ethicon) will be added. Mesh fixation will be done with absorbable staples (Ethicon SecurestrapTM) +/- slow-absorbing resorbable sutures at the discretion of the surgical team. In the case of a diverting stoma, the prophylactic mesh will not encircle it. A Redon-type drainage will be left at the subcutaneous tissue level. One or two drains will be left at the discretion of the surgical team. Closure of the subcutaneous tissue will be performed with 2/0 or 3/0 absorbable, multifilament, interlocking sutures.
Sponsors
Fernandez Zamora
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patients meeting the inclusion criteria will be randomized 1:1 using random number generation in SPSS v.21, assigning them to either the Mesh or Bites group. Sealed opaque envelopes will be used just before the surgical intervention within the operating room. The envelope will be opened in the operating room upon initiation of midline laparotomy closure.
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 necessitating conversion to midline laparotomy. * Urgent surgical intervention required at the level of the colon and/or rectum, even in the presence of other abdominal pathologies. * Age over 18 years. * Signed informed consent (IC) from the patient and the investigator.
Exclusion criteria
* Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD. * BMI ≥ 35 kg/m2. * Re-laparotomies. * 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 incisional hernia. | One year surgery | Compare the incidence of midline laparotomy incisional hernia at one year post-surgery between the two groups: midline laparotomy closure using the small bites technique vs. midline laparotomy closure using the small bites technique supplemented with a suprapubic polypropylene mesh. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of wound infection | 30 postoperative days | Compare the surgical wound infection rate at 30 days post-surgery, postoperative complications hindering subsequent treatment, as well as comorbidity related to surgical wound infection and rates of parastomal hernias. |
| Morbidity and mortality rates | 90 postoperative days | Compare morbidity and mortality between the two groups: initiation of tolerance to a solid oral diet and initiation of ambulation, anastomotic dehiscence, reinterventions, complications according to the Clavien-Dindo classification at 30 and 90 days, and mortality at 90 days. |
Countries
Spain
Contacts
Primary ContactFrank Fernández, Dr.
Outcome results
None listed