Prospective Comparative Evaluation of the Integrated Mesh-Fascial Closure (IMFC) Technique Versus Standard Closure of the Abdominal Wall: A Quasi-Experimental, Non-Randomized Study
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
- 1
- 主要终点
- Recurrence rate of incisional hernia
研究概览
简要总结
This study compares two surgical techniques for closing the abdominal wall in adult patients who have an incisional hernia (a weakness or opening in a previous surgical incision) or who require prophylactic mesh placement during a laparotomy.
In one group, the abdominal wall is closed using the standard technique, in which a polypropylene mesh is fixed independently from the fascial suture. In the other group, a new technique called Integrated Mesh-Fascial Closure (IMFC), developed by the research team, is used: the mesh is incorporated directly within the same continuous suture line that closes the abdominal wall, aiming to better distribute tension across the surgical wound.
The choice of technique is made by the patient after receiving information about both options and providing informed consent. Participants will be followed clinically and with imaging for 18 to 24 months to evaluate the safety, technical feasibility, and reproducibility of the IMFC technique, and to determine the incidence of hernia recurrence in both groups.
详细描述
Incisional hernia is one of the most frequent complications of abdominal surgery, with a reported incidence of 10-20% after laparotomy, and recurrence rates after mesh repair reaching 20-30% in long-term follow-up. In conventional techniques, primary fascial closure and mesh fixation are performed as two mechanically independent steps, concentrating tension on the suture line during the acute postoperative period.
The Integrated Mesh-Fascial Closure (IMFC) technique integrates a macroporous polypropylene mesh within a continuous fascial suture line (pattern: mesh → right fascial edge → left fascial edge → mesh), aiming to distribute tensile load simultaneously between the fascia and the prosthesis, potentially reducing the incidence of hernia recurrence compared to standard closure.
This is a prospective, comparative, quasi-experimental (non-randomized) study conducted at a single center (Hospital Zonal General de Agudos "Dr. Mario V. Larrain," Berisso, Argentina). Eligible patients choose, after informed consent, between standard mesh closure (Group A) or IMFC (Group B). Both groups follow the same clinical and imaging follow-up schedule (days 7, 15, 30; months 2, 6, 12, 18; and a final visit between 18 and 24 months).
The study is designed as an initial, hypothesis-generating comparison of safety, technical feasibility, and reproducibility across surgeons, intended to support a future randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
When feasible, the ultrasound assessment used to determine hernia recurrence is performed by an evaluator independent of and unaware of the surgical technique assigned to the participant, in order to reduce outcome-assessment bias. Blinding of the participant, surgeon, and investigator is not feasible given the nature of the surgical intervention.
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
- •Adults older than 18 years of age
- •Patients with incisional (ventral) hernia
- •Patients with recurrent incisional hernia
- •Incisional hernias with a diameter greater than 4 cm
- •Patients undergoing laparotomy with an indication for prophylactic mesh placement
排除标准
- •Active surgical site infection
- •Overt abdominal contamination
- •Tissue necrosis or inability to achieve primary fascial closure
- •Non-correctable loss of domain
- •Pregnant women or women of childbearing potential planning pregnancy or not using contraception during the follow-up period
- •Patients belonging to vulnerable populations, in accordance with Law 15.462 and applicable ethical guidelines
- •Active oncologic disease (patients with a cured oncologic history may be included)
研究组 & 干预措施
Standard Mesh Closure
Conventional fascial closure using a macroporous polypropylene mesh fixed independently from the closure suture
干预措施: Standard Fascial Closure with Mesh (Procedure)
Integrated Mesh-Fascial Closure - IMFC
Fascial closure using the Integrated Mesh-Fascial Closure (IMFC) technique: the mesh is incorporated within the trajectory of a single continuous fascial suture (pattern: mesh → right fascial edge → left fascial edge → mesh
干预措施: Integrated Mesh-Fascial Closure (Procedure)
结局指标
主要结局
Recurrence rate of incisional hernia
时间窗: 18-24 months (final follow-up visit)
Proportion of participants with hernia recurrence, assessed by clinical physical examination and confirmed by abdominal wall ultrasound when clinically indicated. All ultrasound evaluations performed by the same sonographer throughout the study; the sonographer is aware of study participation but blinded to the specific surgical technique (IMFC vs. standard closure) received by each participant.
Rate of Major Intraoperative and Postoperative Complications
时间窗: Throughout study participation (up to 24 months)
Proportion of participants experiencing a serious adverse event (SAE), defined per ICH E6(R3) as death, a life-threatening event, hospitalization or prolongation of hospitalization, persistent or significant disability, or an unplanned surgical reintervention. Postoperative complications additionally graded using the Clavien-Dindo classification system (Grade I-V) to assess severity.
次要结局
- Operative time and fascial closure time(Intraoperative (during the surgical procedure))
- Postoperative Pain Assessed by the 0-10 Numeric Pain Rating Scale (NRS-11)(Postoperative days 7, 15, and 30)
- Rate of Early Postoperative Complications (Infection, Seroma, Dehiscence, Hematoma)(Up to 30 days postoperative)
- Total Direct Hospital Costs (ARS) Associated with Complications or Reoperations(Up to 24 months (exploratory))
研究者
Bovino Mattano Facundo
Surgeon (General Surgery), Urologist, Principal Investigator
Hospital Zonal General De Agudos Mario V Larrain