Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section In Morbidly Obese Women "A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean operative time
研究概览
简要总结
cesarean section is one of the most common operative procedures performed in modern obstetrics, that become increasingly common in both developed and developing countries for a variety of reasons today, thus any useful refinement in the operative technique, however minimal, is likely to yield substantial benefits.
In morbidly obese women with a panniculus, the supraumbilical incision is a new technique that showed definite advantages over the Pfannenstiel incision that will avoid burying the wound under a large panniculus and affords excellent abdominal exposure, less blood loss, less post-operative pain, earlier ambulation, and shorter hospital stay. All these advantages were attributed to minimal tissue manipulation.
详细描述
The prevalence of obesity has reached pandemic proportions across nations. Morbid obesity has a dramatic impact on pregnancy outcomes. Cesarean section in these women poses many surgical, anesthetic, and logistical challenges.
The rapid upswing in obesity prevalence across nations, ages, and ethnic groups has reached alarming and pandemic proportions.
The prevalence of morbid obesity (BMI>40 kg/m2) has increased by 50% between 2000 and 2005, with 8% of women in the reproductive age group being morbidly obese.
The percentage of women with a body mass index (BMI) of 50 Kg/m2 or more has increased five-fold in 20 years. Obesity is currently the most prevalent health threat the world over and its influence on general health is rapidly increasing.
The incidence of pregnancy-related pathology is higher in obese patients. Obstetricians are often confronted with difficult decisions when such patients are about to give birth. Indeed, in obese patients, labor is induced twice as frequently and vaginal delivery has to be interrupted more frequently due to an abnormal fetal heart rate or fetopelvic disproportion.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients presenting with morbid obesity (BMI > 40)
- •Patients with an abdominal panniculus covering the supra pubic skin crease.
- •Patients with a singleton pregnancy.
- •All indications for elective cesarean section.
- •Hemoglobin ≥ 10 g/dl.
- •Since obesity is a disease associated commonly with co-morbidities such as diabetes mellitus, hypertension and sometimes chest problem these conditions will not be excluded, despite being significant factors that may affect wound healing and this will be analyzed in subgroups.
- •Preoperative glycemic control (HbA1C level < 7 percent) for women with diabetes.
排除标准
- •Antepartum Hemorrhage and placenta previa (more bleeding and operative time anticipated will interfere with the interpretation of operative date)
- •Drugs intake that affects bleeding or tissue healing e.g., anti-coagulants, immunosuppressive drugs and chronic use of steroids (more than 14 days pre-operative).
- •Multiple gestation (higher blood loss is anticipated).
- •Patients diagnosed with intra amniotic infections (infections increases bleeding and incidence for post-operative infections).
- •Patients with (HELLP syndrome) hemolysis, elevated liver enzymes and low platelets or bleeding disorders (the need for blood and blood products is higher than average).
- •Patients with bleeding disorders or auto immune diseases (both affects bleeding and time needed for hemostasis as well as tissue healing).
研究组 & 干预措施
Transverse supraumbilical incision
The skin incision will be performed as a straight transverse skin incision 3-5cm above the umbilicus after maximum retraction of the panniculus caudally using two towel clips, to facilitate the approach to the lower uterine segment.
干预措施: Transverse supraumbilical incision (Procedure)
Pfannenstiel Incision
The skin incision is a transverse upward concavity, typically initiated two finger breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm).
干预措施: Pfannenstiel Incision (Procedure)
结局指标
主要结局
Mean operative time
时间窗: during the procedure
measurement of intra-operative times in minutes
次要结局
- Mean Intra-operative blood loss(During the procedure)
- Occurrence of Post-operative Surgical site infection(7 days)
- Occurrence of surgical complications(during the operation)
- Mean hospital stay(3 days postoperatively)
- VAS score of pain(24 hours)
- Mean Intra-operative blood loss(during the procedure)
研究者
Mohamed Mahmoud Arafa
Principal Investigator
Ain Shams Maternity Hospital