Comparison Between the Use of a Polypropylene (PP) Prophylactic Mesh and a Polyvinylidene Fluoride (PVDF) Mesh in the Closure of Midline Laparotomy in Emergency Colorectal Surgery for High-risk Patients of Incisional Hernia. Impact on Surgical Wound Infection.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incidence of surgical wound infection
研究概览
简要总结
In the latest guidelines for abdominal wall closure in emergency surgery published in the World Journal of Emergency Surgery (WJES) in 2023, no specific recommendations are made in this regard.
Current literature does not provide any articles comparing these two types of mesh materials (PP vs PVDF) in emergency colorectal surgery. It is necessary to conduct a study comparing these two types of mesh materials, specifically in high-risk patients for incisional hernia and emergency colorectal surgery. This study aims to contribute to generating evidence regarding differences in wound infection incidence and potential subsequent complications, such as chronic pain.
It is essential to conduct a study comparing different methods of laparotomy closure, specifically in emergency colorectal surgery, to contribute valuable evidence regarding the incidence of incisional hernia and potential subsequent complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients meeting the inclusion criteria for the study will be randomized 1:1 using random number generation functions with SPSS v.21 software into either the PP or PVDF group. This randomization will be carried out using sealed opaque envelopes at the time immediately preceding the onset of the surgical intervention within the operating room. The envelope will be opened within the operating room once the closure of the midline laparotomy is initiated.
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 diagnosed with colorectal pathology requiring urgent surgical treatment via midline laparotomy.
- •Patients undergoing urgent laparoscopic surgery but requiring conversion to midline laparotomy.
- •Need for urgent surgical treatment involving the colon and/or rectum, even in the presence of other abdominal pathologies.
- •Age over 18 years.
- •Signed informed consent (IC) from both the patient and the investigator
- •Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD.
- •BMI ≥ 35 kg/m
- •Re-laparotomies.
排除标准
- •Patients with psychiatric illnesses, addictions, or any disorder hindering the understanding of the Informed Consent.
- •Inability to read or comprehend any of the languages in the Informed Consent (Catalan, Spanish).
结局指标
主要结局
Incidence of surgical wound infection
时间窗: 30 postoperative days
Compare the incidence of surgical wound infection between the two groups: Closure of midline laparotomy using the "small bites" technique associated with a suprafascial polypropylene mesh versus closure of midline laparotomy using the "small bites" technique associated with a suprafascial polyvinylidene fluoride mesh.
次要结局
- Morbidity and mortality rates(90 postoperative days)
- Rate of incisional hernia(One year surgery)
研究者
Fernandez Zamora
Principal Investigator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta