Status:
UNKNOWN
The Efficacy and Security of the Small Stitch Technique in Emergency Surgery
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Abdominal Wall Defect
Abdominal Wall Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study evaluates the abdominal closure technique in emergency surgery. Half of participants will be perform the classic Large Stitch technique, while the other half will undergo the Small Stitch t...
Detailed Description
The closure of laparotomy is one of the most important challenges facing the surgeon. The classic technique of wall closure is the Large Stitch technique that uses monofilament double-strand sutures ...
Eligibility Criteria
Inclusion
- Patients over 18 years of age and who provide informed consent to participate in the study.
- Patients requiring an urgent midline laparotomy with a minimum size of 8 cm.
Exclusion
- Prior midline laparotomy.
- Patients with BMI\> 45 kg / m2
- Patients with ASA (American Society of Anesthesiologists)\> IV.
- Patient with an advanced terminal illness with an expectation of life \<1 year.
- Patients with abdominal aortic aneurysm.
- Patients with coagulopathy: patient previously diagnosed with von Willebrand disease, hemophilia or Immune thrombocytopenic purpura.
- Immunosuppressed patient: HIV patients in the AIDS phase, chronic corticosteroid or immunosuppressive treatment.
- Patients with collagen pathology: patient previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, homocystinuria and scleroderma.
- Chemotherapeutic treatment 2 weeks before surgery.
- Radiotherapy treatment 6 weeks before surgery.
- Diffuse peritonitis with hemodynamic instability, defined by non-response to fluids prior to surgery or during the surgical process.
- Pregnant or potentially fertile women, breastfeeding, or intention to become pregnant, or those who do not wish to use effective contraception (hormonal contraceptives (implantation, patches, oral), and double barrier methods (any double combination of: IUD (intrauterine device), male or female prophylactics with spermicidal gel, diaphragm, contraceptive sponge, cervical cap).
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03765060
Start Date
October 1 2018
End Date
December 1 2021
Last Update
January 13 2021
Active Locations (1)
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1
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013