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

Colorectal Cancer Clinical Trial

— BITEME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220058
• Other study ID #: 2023.227
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: January 15, 2027

Study information

• Verified date: January 2024
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: Frank Fernández, Dr.
• Phone: 972 94 02 60
• Email: frankafernandez.girona.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: January 15, 2027
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Emergencies
• Hernia
• Incisional Hernia
• Wound Infection

Intervention

Procedure:
• Closure 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.
• Closure 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

Country	Name	City	State
Spain	Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona,	Girona	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
Fernandez Zamora

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year surgery
Secondary	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.	30 postoperative days
Secondary	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.	90 postoperative days