Scalpel Versus Diathermy for Transverse Abdominal Incision in Women Undergoing First Elective Caesarean Section: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Incision blood loss
研究概览
简要总结
The objective of this study will be to compare two methods of skin incisions during the first caesarean section (CS), that is scalpel and diathermy, assessing differences in blood loss during incision, incisional time, total surgery time, post-operative pain, wound healing, complications, and cosmetic outcomes.
详细描述
The scalpel has been historically used as the primary cutting tool during caesarean section (CS). However, advancements in surgical devices have introduced alternatives, such as the option to make a diathermic cut using electrosurgical units.
General surgeons have extensively demonstrated the advantages of diathermy over the scalpel for abdominal wall incisions, including faster opening time, reduced incisional blood loss, decreased post-operative pain, and a comparable wound complication rate.
In obstetrics, there is a scarcity of evidence in this regard, and no consensus or guidelines have been established regarding the optimal method for making a transverse abdominal incision during the first elective CS. Currently, the choice between using a scalpel or diathermy remains at discretion of the obstetric surgeon. The objective of this study will be to compare both methods of skin incisions during the first CS, assessing differences in blood loss during incision, incisional time, total surgery time, post-operative pain, wound healing, complications, and cosmetic outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women without a history of previous cesarean section or other abdominal surgery
- •Age greater then 18 years (only adult patients)
- •Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
- •Gestational age greater then 37 weeks (at term pregnancies)
- •No contraindications to spinal anesthesia
- •Indication to elective CS: extra-obstetrical reasons, failure of medical induction of labor, breech fetal presentation
- •Informed consent
排除标准
- •Women refusing to participate in the study
- •Women undergoing urgency or emergency cesarean deliveries
- •Women with a history of previous cesarean section or abdominal surgery
- •Women with multifetal pregnancies
- •Necessity of general anesthesia
- •Use of anticoagulants
- •Patients needing a median longitudinal abdominal section
- •Patients with pacemakers
- •Allergy to cephalosporins
- •Any medical disorder that can affect wound healing as diabetes, hypertension, hepatic or renal diseases, chronic anemia, chronic skin conditions, congenital or acquired bleeding diathesis.
结局指标
主要结局
Incision blood loss
时间窗: During surgery
This will be calculated by weighing the gauze pre and postoperatively (1mg = 1ml) after complete hemostasis will be achieved.
次要结局
- Total surgery time(During surgery)
- Incision time(During surgery)
- Wound complications(During the first month after surgery)
- Post-operative pain assessed by VAS(During the first three days after surgery)
- Cosmetic wound evaluation assessed by POSAS(One month after surgery)
研究者
Prof.Amerigo Vitagliano
MD, PhD, Assistant Professor (Researcher type-B)
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari