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RecruitingNot ApplicableNCT06220058

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

Sponsor

Fernandez Zamora

Enrollment

148 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal, CancerWound InfectionIncisional Hernia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This surgical trial is comparing whether a mesh reinforcement or a specific stitching technique called "small bites" is better at preventing incisional hernia (a bulge through the surgical scar) after emergency colon or rectal surgery through a midline abdominal incision. **You may be eligible if...** - You need urgent colorectal surgery through a midline abdominal cut - You are 18 or older and can give informed consent in Spanish or Catalan **You may NOT be eligible if...** - Your BMI is 35 or higher - You have severe COPD - You are undergoing a repeat abdominal surgery (re-laparotomy) - You have a psychiatric illness, addiction, or impairment preventing you from understanding the consent - You cannot read Spanish or Catalan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona,

Girona, Catalonia, Spain

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NCT06220058

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