Clinical trial NCT03765060: The Efficacy and Security of the Small Stitch Technique in Emergency Surgery
Official title: Clinical Trial on the Efficacy and Security of the Small Stitch Technique Versus the Large Stitch Closure Laparotomy Technique in Emergency Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Wall Defect
Abdominal Wall Hernia
Eventration
Evisceration; Operation Wound
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 technique.

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 with a SL/WL (Suture Lengh/Wound Lengh) 4:1 ratio, with a distance to the alba line and between each stitch of 1 cm.

Nowadays, the Small Stitch technique is accepted as the technique of choice for closure of laparotomies in programmed surgery. It is based on a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR (Half-circle Round body) 26 needle. Stitches should be given with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches.

There are very few studies about the role of Small Stitch technique in the field of Emergency Surgery where the increased morbidity of the patient and the higher rate of surgical wound infection can play a fundamental role, and could be improved with the use of new abdominal wall closure techniques.

Eligibility criteria: 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).

Primary outcomes:
measure: Efficacy of the small stitch technique defined by eventration rate
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy of the small stitch technique defined by local complications rate
timeFrame: 1 year
measure: Efficacy of the small stitch technique defined by evisceration rate
timeFrame: 1 year
measure: Efficacy of the small stitch technique defined by improvement of quality of life
timeFrame: 1 year
measure: Security of the small stitch technique
timeFrame: 1 year
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
Study officials:
affiliation: Hospital Universitario Virgen del Rocio
name: Tamayo López María Jesús, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen del Rocio
name: Padillo Ruiz Francisco Javier, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: O'Dwyer PJ, Courtney CA. Factors involved in abdominal wall closure and subsequent incisional hernia. Surgeon. 2003 Feb;1(1):17-22. doi: 10.1016/s1479-666x(03)80004-5.
citation: 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. doi: 10.1002/bjs.1800801020.