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

Last updated: October 6, 2024
Sponsor: Fernandez Zamora
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer; Rectal Cancer

Colon Cancer

Treatment

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

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

Clinical Study ID

NCT06220058
2023.227
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with colorectal pathology requiring urgent surgical treatment viamidline laparotomy.

  • Patients undergoing urgent laparoscopic surgery but necessitating conversion tomidline laparotomy.

  • Urgent surgical intervention required at the level of the colon and/or rectum, evenin the presence of other abdominal pathologies.

  • Age over 18 years.

  • Signed informed consent (IC) from the patient and the investigator.

Exclusion

Exclusion Criteria:

  • Severe chronic obstructive pulmonary disease (COPD) according to the GOLDclassification or decompensated COPD.

  • BMI ≥ 35 kg/m2.

  • Re-laparotomies.

  • Patients with psychiatric illnesses, addictions, or any disorder hindering theunderstanding of the Informed Consent.

  • Inability to read or comprehend any of the languages in the Informed Consent (Catalan, Spanish).

Study Design

Total Participants: 148
Treatment Group(s): 2
Primary Treatment: Closure of the midline laparotomy using the "small bites" technique
Phase:
Study Start date:
February 05, 2024
Estimated Completion Date:
January 15, 2027

Connect with a study center

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

    Girona, Catalunya 17001
    Spain

    Active - Recruiting

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