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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFernandez Zamora

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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 with an absorbable PP mesh

    Procedure/Surgery

    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.

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Group BitesExperimental treatment 1 intervention
Group B: Group MeshExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of incisional hernia.

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.

Time frame
One year surgery

Secondary outcomes

1

Incidence of wound infection

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.

Time frame
30 postoperative days
2

Morbidity and mortality rates

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.

Time frame
90 postoperative days

Other outcomes

Sponsors and contacts

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Fernandez Zamora

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Sponsor institution