Abdominal Wall Defect Clinical Trial
— STCUOfficial title:
Clinical Trial on the Efficacy and Security of the Small Stitch Technique Versus the Large Stitch Closure Laparotomy Technique in Emergency Surgery
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 technique.
Status | Recruiting |
Enrollment | 105 |
Est. completion date | December 1, 2021 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients over 18 years of age and who provide informed consent to participate in the study. 2. Patients requiring an urgent midline laparotomy with a minimum size of 8 cm. Exclusion Criteria: 1. Prior midline laparotomy. 2. Patients with BMI> 45 kg / m2 3. Patients with ASA (American Society of Anesthesiologists)> IV. 4. Patient with an advanced terminal illness with an expectation of life <1 year. 5. Patients with abdominal aortic aneurysm. 6. Patients with coagulopathy: patient previously diagnosed with von Willebrand disease, hemophilia or Immune thrombocytopenic purpura. 7. Immunosuppressed patient: HIV patients in the AIDS phase, chronic corticosteroid or immunosuppressive treatment. 8. Patients with collagen pathology: patient previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, homocystinuria and scleroderma. 9. Chemotherapeutic treatment 2 weeks before surgery. 10. Radiotherapy treatment 6 weeks before surgery. 11. Diffuse peritonitis with hemodynamic instability, defined by non-response to fluids prior to surgery or during the surgical process. 12. 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). |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Virgen Del Rocio | Sevilla |
Lead Sponsor | Collaborator |
---|---|
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
Spain,
Israelsson LA, Jonsson T. Suture length to wound length ratio and healing of midline laparotomy incisions. Br J Surg. 1993 Oct;80(10):1284-6. — View Citation
Israelsson LA, Millbourn D. Closing midline abdominal incisions. Langenbecks Arch Surg. 2012 Dec;397(8):1201-7. doi: 10.1007/s00423-012-1019-4. Epub 2012 Nov 11. Review. — View Citation
Millbourn D, Cengiz Y, Israelsson LA. Risk factors for wound complications in midline abdominal incisions related to the size of stitches. Hernia. 2011 Jun;15(3):261-6. doi: 10.1007/s10029-010-0775-8. Epub 2011 Jan 30. — View Citation
Millbourn D, Wimo A, Israelsson LA. Cost analysis of the use of small stitches when closing midline abdominal incisions. Hernia. 2014;18(6):775-80. doi: 10.1007/s10029-013-1135-2. Epub 2013 Jul 10. — View Citation
O'Dwyer PJ, Courtney CA. Factors involved in abdominal wall closure and subsequent incisional hernia. Surgeon. 2003 Feb;1(1):17-22. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of the small stitch technique defined by eventration rate | To determine the efficacy of the "Small stitch" technique versus the "Large Stitch" technique in the closure of midline laparotomy with respect to the production of eventration in patients undergoing urgent abdominal surgery. | 1 year | |
Secondary | Efficacy of the small stitch technique defined by local complications rate | To determine whether the closure of midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery reduces the local complications of the surgical wound defined by hematoma, seroma or wound infection. | 1 year | |
Secondary | Efficacy of the small stitch technique defined by evisceration rate | To determine if the closure of the midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery reduces the rate of evisceration. | 1 year | |
Secondary | Efficacy of the small stitch technique defined by improvement of quality of life | To determine if the closure of a midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery improves the quality of life. | 1 year | |
Secondary | Security of the small stitch technique | To determine the safety of the Small Stitch technique versus the "Large Stitch" technique in the closure of the midline laparotomy with respect to the incidence of adverse events and serious adverse events, the incidence of side effects related to the treatment and the incidence and the reasons for premature withdrawal of premature patient from the study. | 1 year |
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