Difference Between Pfannenstiel Incision and Higher Transverse Supra Umbilical Incision, During Elective Cesarean Section in Morbidly Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Rate of surgical site wound infection
研究概览
简要总结
The goal of this comparative clinical trial is to compare Pfannenstiel incision and higher transverse supra umbilical incision techniques during elective cesarean section in morbidly obese patients. The main questions it aims to answer are:
Is there a difference in operative time between the two incision techniques? Is there a difference in estimated blood loss between the two techniques? Is there a difference in post-operative pain scores between the two techniques? Is there a difference in wound complication rates between the two techniques? Participants will be randomly assigned to receive either a Pfannenstiel incision or a higher transverse supra umbilical incision during their scheduled cesarean delivery.
Researchers will compare the Pfannenstiel incision group to the higher transverse supra umbilical incision group to see if there are differences in operative time, blood loss, post-operative pain, and wound complications.
详细描述
This randomized controlled trial will enroll 60 morbidly obese pregnant patients scheduled for elective cesarean delivery at gestational age ≥37 weeks. Morbid obesity will be defined as pre-pregnancy body mass index ≥40 kg/m2.
Patients will be randomly allocated to one of two groups (30 patients per group):
Group 1 (Pfannenstiel group): Patients will undergo a transverse infraumbilical skin incision 2-3 cm above the symphysis pubis, followed by transverse incision of the anterior rectus sheath in the same line as the skin incision, blunt digital separation of the rectus muscles, and transverse uterine incision in the lower segment.
Group 2 (Supra-umbilical transverse group): Patients will undergo a transverse skin incision halfway between the umbilicus and xiphoid process, followed by transverse incision of the anterior rectus sheath in the same line, blunt digital separation of the rectus muscles, and transverse uterine incision in the lower segment.
The primary outcome measures will be operative time, estimated blood loss, post-operative pain scores, and wound complication rates. Secondary outcomes will include length of hospital stay, patient satisfaction scores, and cosmetic results.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged between 20 and 40 years.
- •Singleton pregnancy.
- •Gestational age ≥ 37 weeks.
- •Scheduled for elective cesarean delivery.
- •Morbid obesity, defined as pre-pregnancy body mass index (BMI) ≥ 40 kg/m
- •Willing and able to provide informed consent.
- •Able to adhere to study procedures and follow-up schedule.
排除标准
- •Emergency cesarean delivery.
- •Multiple gestation (twins, triplets, etc)
- •Placenta previa or vasa previa.
- •History of more than 1 previous cesarean delivery.
- •HIV, hepatitis B/C infection.
- •Current anticoagulation therapy.
- •Immune-compromised conditions.
- •Premature rupture of membranes.
- •Pre-existing skin conditions affecting the abdomen.
- •Inability to provide informed consent.
结局指标
主要结局
Rate of surgical site wound infection
时间窗: 4 weeks after the surgery.
Surgical site infections will be assessed at the cesarean incision site and tracked for 4 weeks postoperatively. Wound infection will be defined as purulent drainage from the incision, positive culture, and/or at least two of the following signs or symptoms: pain or tenderness, localized swelling, redness, or heat. The 4-week timeframe starts on the day of surgery (day 0) and ends 28 days postoperatively. Wound infections occurring up to 4 weeks after surgery will be captured and recorded as the primary outcome measure. Wound assessments will be performed daily during the hospital stay, at the post-op visit around 2 weeks, and at the 4-week follow-up visit.
次要结局
- Estimated blood loss(during the procedure)
- Operative time(during the surgery)
- Hospital length of stay(From day of surgery to discharge, up to 8 weeks.)
- Postoperative pain(From end of surgery through 4 weeks postoperatively)
研究者
Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy
lecturer and consultant at Obstetrics and Gynecology Department.
Al-Azhar University