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NCT Number: NCT06220045

Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.

In the latest guidelines for abdominal wall closure in emergency surgery published in the World Journal of Emergency Surgery (WJES) in 2023, no specific recommendations are made in this regard.

Current literature does not provide any articles comparing these two types of mesh materials (PP vs PVDF) in emergency colorectal surgery. It is necessary to conduct a study comparing these two types of mesh materials, specifically in high-risk patients for incisional hernia and emergency colorectal surgery. This study aims to contribute to generating evidence regarding differences in wound infection incidence and potential subsequent complications, such as chronic pain.

It is essential to conduct a study comparing different methods of laparotomy closure, specifically in emergency colorectal surgery, to contribute valuable evidence regarding the incidence of incisional hernia and potential subsequent complications.

Recruiting

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hernia Hernia Incisional Incisional Hernia Infections Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Girona, 17001, Spain

Location status: Recruiting

Location contact

Frank Fernández

CONTACT

[email protected]

972 94 02 60

Jorge García-Adámez, Dr.

SUB_INVESTIGATOR

Lidia Cornejo, MsC

SUB_INVESTIGATOR

Pere Planellas, Dr.

SUB_INVESTIGATOR

Ramon Farrés, Dr.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with colorectal pathology requiring urgent surgical treatment via midline laparotomy.
  • Patients undergoing urgent laparoscopic surgery but requiring conversion to midline laparotomy.
  • Need for urgent surgical treatment involving the colon and/or rectum, even in the presence of other abdominal pathologies.
  • Age over 18 years.
  • Signed informed consent (IC) from both the patient and the investigator
  • Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD.
  • BMI ≥ 35 kg/m2.
  • Re-laparotomies.

Exclusion criteria

  • 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).

Treatment and study plan

Polyvinylidene fluoride mesh

Combination Product

Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh.

Prophylactic polypropylene mesh

Combination Product

Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh.

Primary outcomes

  1. Incidence of surgical wound infection

    Time frame: 30 postoperative days

    Compare the incidence of surgical wound infection between the two groups: Closure of midline laparotomy using the "small bites" technique associated with a suprafascial polypropylene mesh versus closure of midline laparotomy using the "small bites" technique associated with a suprafascial polyvinylidene fluoride mesh.

Secondary outcomes

  1. Rate of incisional hernia

    Time frame: One year surgery

    Compare the rate of incisional hernia at one year post-surgery, postoperative complications, and abdominal pain at 6 and 12 months in both groups. Also, compare the rates of parastomal hernias.

  2. Morbidity and mortality rates

    Time frame: 90 postoperative days

    Comparison between the two groups on various aspects related to postoperative morbidity and mortality. Other aspects to be evaluated include the time of initiation of tolerance to solid oral diet, onset of ambulation, presence of anastomotic dehiscence, need for reinterventions, and occurrence of complications according to the Clavien-Dindo classification at 30 and 90 days, as well as the mortality rate at 90 days. Additionally, the aim is to compare the rate of initiation of adjuvant treatment within the first 6 weeks post-surgery, if indicated.

Study contacts

Contact information is provided by the study sponsor or research team.

Frank Fernández, Dr.

CONTACT

[email protected]

972 94 02 60

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Other

Registry information

Official study title

Comparison Between the Use of a Polypropylene (PP) Prophylactic Mesh and a Polyvinylidene Fluoride (PVDF) Mesh in the Closure of Midline Laparotomy in Emergency Colorectal Surgery for High-risk Patients of Incisional Hernia. Impact on Surgical Wound Infection.

Acronym: PROFIMESH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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