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

Fernandez Zamora

Status: Enrolling

Conditions: Incisional Hernia; Wound Infection; Colorectal Cancer

Treatments: Procedure: Closure of the midline laparotomy using the "small bites" technique with an absorbable PP mesh; Procedure: Closure of the midline laparotomy using the "small bites" technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06220058

2023.227

Details and patient eligibility

About

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.

Enrollment: 148 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Group Bites

Experimental group

Description:

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

Treatment:

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

Group Mesh

Experimental group

Description:

Closure of the midline laparotomy using the "small bites" technique adding a suprapubic polypropylene mesh.

Treatment:

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