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Search / Trial NCT06220058

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

Launched by FERNANDEZ ZAMORA · Jan 22, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Colorectal Cancer Hernia Incisional Wound Infection Small Bites

ClinConnect Summary

This clinical trial is studying two different methods of closing the abdomen after emergency surgery for colorectal issues, such as colorectal cancer. The goal is to understand which method might help prevent complications like incisional hernias, which are bulges that can happen after surgery. The trial aims to gather more evidence since current guidelines do not provide clear recommendations for how to best close the abdomen in these urgent situations.

To be eligible for this study, participants should be adults over 18 years old who are having emergency surgery for colorectal problems. This includes those who need a specific type of surgery called midline laparotomy or those who start with a minimally invasive technique but need to switch to a more open approach. However, patients with certain health issues, such as severe lung disease or a high body mass index (BMI), cannot participate. Those who join the study will need to give their consent and can expect to be part of a comparison between the two surgical closure techniques, helping doctors learn more about the best ways to care for patients in the future.

Gender

ALL

Eligibility criteria

  • 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).

About Fernandez Zamora

Fernandez Zamora is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on developing novel therapeutic solutions, the organization collaborates with leading healthcare professionals and research institutions to conduct rigorous clinical trials across various therapeutic areas. Fernandez Zamora emphasizes ethical practices, patient safety, and data integrity, striving to contribute meaningful insights to the medical community while improving patient outcomes. Their expertise in trial management and commitment to excellence positions them as a valuable partner in the pursuit of groundbreaking health advancements.

Locations

Girona, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported