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

NCT06220058 | Recruiting

• 1 other identifier: 2023.227
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer; Incisional Hernia; Wound Infection

Keywords

colorectal cancer; Hernia Incisional; Wound infection; small bites

Outcome Measures

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.

  One year surgery

Secondary Outcomes (2)

• Incidence of wound infection

  30 postoperative days

• Morbidity and mortality rates

  90 postoperative days

Study Arms (2)

Group Bites

EXPERIMENTAL

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

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

Group Mesh

EXPERIMENTAL

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

Interventions

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

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.

Group Bites

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 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.

Group Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fernandez Zamora: lead

Study Sites (1)

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

Girona, Catalonia, 17001, Spain

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Incisional Hernia; Wound Infection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Infections

Central Study Contacts

Frank Fernández, Dr.

CONTACT

972 94 02 60; frankafernandez.girona.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients meeting the inclusion criteria will be randomized 1:1 using random number generation in SPSS v.21, assigning them to either the Mesh or Bites group. Sealed opaque envelopes will be used just before the surgical intervention within the operating room. The envelope will be opened in the operating room upon initiation of midline laparotomy closure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 23, 2024
• Study Start: February 5, 2024
• Primary Completion: January 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)