Clinical Trial on the Efficacy and Security of the Small Stitch Technique Versus the Large Stitch Closure Laparotomy Technique in Emergency Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Efficacy of the small stitch technique defined by eventration rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Efficacy of the small stitch technique defined by eventration rate
时间窗: 1 year
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.
次要结局
- Efficacy of the small stitch technique defined by evisceration rate(1 year)
- Efficacy of the small stitch technique defined by improvement of quality of life(1 year)
- Efficacy of the small stitch technique defined by local complications rate(1 year)
- Security of the small stitch technique(1 year)