Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06220058

Comparison of Polypropylene Mesh and Small Bites Technique for Midline Laparotomy Closure in Emergency Colorectal Surgery to Prevent Incisional Hernia

Led by Fernandez Zamora · Updated on 2024-10-08

148

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating different methods to close the midline laparotomy incision in emergency colorectal surgery. The aim is to compare the use of a prophylactic polypropylene mesh with the "small bites" suture technique to see which approach better prevents incisional hernias and related complications. This study addresses a gap in current guidelines, which lack clear recommendations for emergency abdominal wall closure due to limited and varied existing evidence. The study includes two procedures: one group will have their incision closed using the "small bites" technique with a monofilament polydioxanone suture, without leaving a drainage system in the subcutaneous tissue. The other group will have the same "small bites" closure but with the addition of a partially absorbable low-density polypropylene mesh fixed with absorbable staples or sutures. Drainage systems and closure of the subcutaneous tissue will be managed based on surgical team discretion, especially if a diverting stoma is present. Participants will be adults undergoing urgent colorectal surgery via midline laparotomy or laparoscopic surgery converted to midline laparotomy. Researchers will track the incidence of incisional hernias over one year after surgery as the primary outcome. Safety and potential complications like wound infection will also be monitored. The study requires signed informed consent and involves ongoing follow-up to assess surgical outcomes and any hernia development.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 with other abdominal pathologies
  • Age over 18 years
  • Signed informed consent from patient and investigator
Not Eligible

You will not qualify if you...

  • Severe or decompensated chronic obstructive pulmonary disease (COPD) as per GOLD classification
  • Body mass index (BMI) of 35 kg/m2 or higher
  • Previous midline laparotomy surgeries (re-laparotomies)
  • Psychiatric illnesses, addictions, or disorders preventing understanding of informed consent
  • Inability to read or understand informed consent languages (Catalan, Spanish)

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Girona, Catalonia, Spain, 17001

Actively Recruiting

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Research Team

F

Frank Fernández, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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