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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Wound Infection; Incisional Hernia
• Intervention / Treatment: Procedure: Closure of the midline laparotomy using the "small bites" technique; Procedure: Closure of the midline laparotomy using the "small bites" technique with an absorbable PP mesh

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frank Fernández, Dr.; Phone Number: 972 94 02 60; Email: frankafernandez.girona.ics@gencat.cat

Study Locations

• Spain
  • Catalunya
    • Girona, Catalunya, Spain, 17001
      • Recruiting
      • Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona,
      • Contact: Frank Fernández, Dr.; Phone Number: 972 94 02 60; Email: cirurgia.girona.ics@gencat.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Bites; Closure of the midline laparotomy using the "small bites" technique	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.
Experimental: Group Mesh; Closure of the midline laparotomy using the "small bites" technique adding a suprapubic polypropylene mesh.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fernandez Zamora

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2024
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: colorectal cancer; Wound infection; Hernia Incisional; small bites
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Neoplasms; Neoplasms by Site; Postoperative Complications; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Emergencies; Hernia; Colorectal Neoplasms; Wound Infection; Incisional Hernia
• Other Study ID Numbers: 2023.227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No