Concomitant Abdominoplasty with Ventral Hernia Repair Versus Ventral Hernioplasty . a Randomized Comparative Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- Recurrence rate
研究概览
简要总结
Comparison between hernioplasty alone versus concomitant abdominoplasty with ventral hernia repair regarding efficacy and post-operative recurrence of hernia.
详细描述
Ventral hernias are very common and do present a challenge because of the risk of recurrence.
Ventral hernias of the abdomen are defined as a non-inguinal, nonhiatal defect in the fascia of the abdominal wall. Annually, there are about 350,000 ventral hernia operations. The repair of these abdominal wall defects is a common surgery performed by general surgeons. Surgery is typically recommended for individuals with acceptable operative risk, symptomatic hernias, or those at elevated risk of developing complications from a hernia. They can affect an individual's quality of life and can lead to hospitalizations and even death in some cases.[1][2][3] Common causes of acquired ventral hernias include previous surgery causing an incisional hernia, trauma, and repetitive stress on naturally weak points of the abdominal wall. These naturally occurring weak points in the abdominal wall include the umbilicus, semilunar line, ostomy sites, bilateral inguinal regions, and esophageal hiatus. Obesity is a large component of hernias as well because it stretches the fascia of the abdomen causing it to weaken. Specifically, the action of repetitive weight gain and loss leads to weakening.[4] Reported recurrence rates after VHR in the literature vary widely and range from 2.7% to 20% for primary ventral hernia (umbilical and epigastric) to 32-37% for incisional hernia repairs, depending on the series in question. (5) Abdominoplasty can be performed in combination with hernia repair in patients with ventral hernias, especially when associated with large midline ventral hernias, diastasis of recti and the associated laxity and abdominal shape deformity, represent aesthetic and functional problems for the patients. So, the surgical treatment of both pathologies at the same time is highly recommended if the patient's general condition permits. This can be achieved by a comprehensive technique incorporating abdominoplasty performed by a transverse lower abdominal incision into any of the hernia repair techniques.(6) The procedure continues to become increasingly popular, and this is attributed to the increasing rates of obesity and subsequent use of weight loss surgery
Aim(s) of the Research (50 words max):
Is to compare the outcome and efficacy of the combined procedure of (abdominoplasty and hernioplasty) to hernioplasty alone according to rate of post operative recurrence of hernia .
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with age more than 20 years and less than 60 years old.
- •Female patients.
- •Patients having ventral hernias with BM more than 25 kg/m
- •Patients with floppy abdomen Patients with divercation of recti Patients with an (ASA) classification of 3 or less with no history of DM or other major comorbidities as cardiopulmonary, hepatic, or renal impairment.
排除标准
- 未提供
研究组 & 干预措施
Concomitant abdominoplasty with ventral hernia repair .
We do abdominoplasty with concomitant repair of the hernial defect and abdominal wall muscles in the same setting.
干预措施: Abdominoplasty with ventral hernia repair versus ventral hernioplasty. (Procedure)
Ventral Hernioplasty
We do hernioplasty with mesh placement for a surgical treatment for ventral hernia.
干预措施: Abdominoplasty with ventral hernia repair versus ventral hernioplasty. (Procedure)
结局指标
主要结局
Recurrence rate
时间窗: Baseline
Comparison between the two procedures regarding the rate of recurrence within the two patients groups.
Umbilical ischaemic changes
时间窗: Baseline
Detection of post operative ishaemia and necrosis of umbilicus as a known complication of abdominoplasty procedure.
次要结局
未报告次要终点
研究者
Mark Natey Abdo Barsom
Resident at general and laparoscopic surgery department , assiut university hospital.
Assiut University
