Symptoms and General Pathology

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Hernia

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Incisional Hernia

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Disease Attributes

Pathological Conditions, Anatomical

Postoperative Complications

Closure of the midline laparotomy using the "small bites" technique

Closure of the midline laparotomy using the "small bites" technique adding a suprapubic polypropylene 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). No Redon drainage system will be left in the subcutaneous tissue.

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.

Closure of the midline laparotomy using the "small bites" technique with an absorbable PP mesh

Frank Fernández, Dr.

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.

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.

Comparing Polypropylene Mesh and "Small Bites" Technique in Emergency Colorectal Surgery's Midline Laparotomy Closure. Study for Incisional Hernia Prevention.

Comparison Between the Use of a Prophylactic Polypropylene Mesh and the "Small Bites" Technique in Midline Laparotomy Closure for Emergency Colorectal Surgery for Incisional Hernia Prevention

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.

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.

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.

Fernandez Zamora

Principal Investigator

Surgical Wound Infection

Surgical Wound

All Drugs and Chemicals

Fluorides

Protective Agents

In all patients, surgery will be performed according to their individual pathology. Once midline laparotomy closure is initiated, randomization will be conducted, and patients will be assigned to one of the two groups.

PVDF Group (Polyvinylidene Fluoride Mesh): Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh

In all patients, surgery will be performed according to their individual pathology. Once midline laparotomy closure is initiated, randomization will be conducted, and patients will be assigned to one of the two groups.

PP Group (Polypropylene Mesh): Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh.

Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh.

Polyvinylidene fluoride mesh

Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh.

Prophylactic polypropylene mesh

Frank Fernández

Pere Planellas, Dr.

Ramon Farrés, Dr.

Jorge García-Adámez, Dr.

Lidia Cornejo, MsC

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.

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.

Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.

Comparison Between the Use of a Polypropylene (PP) Prophylactic Mesh and a Polyvinylidene Fluoride (PVDF) Mesh in the Closure of Midline Laparotomy in Emergency Colorectal Surgery for High-risk Patients of Incisional Hernia. Impact on Surgical Wound Infection.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparing Polypropylene Mesh and "Small Bites" Technique in Emergency Colorectal Surgery's Midline Laparotomy Closure. Study for Incisional Hernia Prevention.	NCT06220058	Colorectal Canc... Incisional Hern... Wound Infection	Closure of the ... Closure of the ...	18 Years -	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Comparing Polypropylene Mesh and "Small Bites" Technique in Emergency Colorectal Surgery's Midline Laparotomy Closure. Study for Incisional Hernia Prevention.	NCT06220058	Colorectal Canc... Incisional Hern... Wound Infection	Closure of the ... Closure of the ...	18 Years -	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.	NCT06220045	Colorectal Canc... Wound Infection Hernia Incision...	Polyvinylidene ... Prophylactic po...	18 Years -	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Spots Global Cancer Trial Database for hernia incisional