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

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

Inclusion Criteria5

  • 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 Criteria5

  • 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).

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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