Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Endometritis
研究概览
简要总结
To evaluate the effects of extra-abdominal repair of the uterine incision compared to intra-abdominal repair, and to study is there superiority of one technique over the other in terms of primary outcomes - operative( up to 4 hours after beginning of anesthesia) and post operative ( until day 4 after operation ) measurements , secondary outcomes, long-term outcomes and subjective outcomes.
PRIMARY OUTCOMES:
Intra - operative ( during the operation up to 4 hours from anesthesia )
- nausea and vomiting
- intraoperative hypotension
- intraoperative pain
Post operative ( 4 hours from anesthesia and until release from hospital )
- Blood transfusion
- Venous thromboembolism
- Febrile Morbidity
- Endometritis
- Wound Infection
- Death
Subjective measures:
- complain of pain 1-10 on day 1 post operative
- time until walking
- number of Days until having bowel movement
- overall satisfactory
SECONDARY OUTCOMES:
- Operative time
- Estimated blood loss ( ebl ) - hemoglobin levels
- Hospital stay
详细描述
Cesarean section (CS) delivery is one of the most frequent surgical procedures to be performed worldwide and rates of CS delivery are increasing. In the late 80's, the rate of caesarean deliveries was 10-13 % in most of the big hospitals in Israel, and today it reaches up to 20-25% of all deliveries.
Numerous different surgical techniques for caesarean section delivery have been described, and the debate about the optimal caesarean technique to minimize surgical morbidity is ongoing.
One of the more controversial issues regarding caesarean technique is the manner by which uterine repair is conducted after delivery of the infant(s) and placenta.
Two techniques are being used depending on the uterus position during repairmen : In situ within the peritoneal cavity (intra- abdominal repair) or temporarily exteriorized onto the mother's abdomen (extra- abdominal repair).
Arguments in favor of temporary exteriorization include better visualization of any uterine extensions and more rapid uterine repair with consequent reductions in both operative time and intraoperative blood loss. Opponents of extraabdominal repair argue that this technique increases rates of intraoperative nausea and vomiting, adnexal trauma on replacement, possible infection, and venous air embolism (VAE) .
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton pregnancy
- •term pregnancy
排除标准
- •chorioamnionitis
- •uterine rupture
- •hysterotomy - adhesiolysis
研究组 & 干预措施
intra-abdominal repair
intra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.
干预措施: Intra-abdominal repair (Procedure)
extra-abdominal repair
extra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.
干预措施: Extra-abdominal repair (Procedure)
结局指标
主要结局
Endometritis
时间窗: post operative- untill release from hospitalization usually day 4
Death
时间窗: post operative - untill release from hospitalization usually day 4
Venous thromboembolism
时间窗: durind operation - 4 hours from anasthesia
intraoperative hypotension
时间窗: during operation- 4 hours from anasthesia
intraoperative pain
时间窗: during operation- 4 hours from anasthesia
Wound Infection
时间窗: post operative- untill release from hospitalization usually day 4
nausea and vomiting
时间窗: during operation- 4 hours from anasthesia
Blood transfusion
时间窗: during operation- 4 hours from anasthesia
Febrile Morbidity
时间窗: post operative - untill release from hospitalization usually day 4
次要结局
- Operative time(operative time - since anasthesia untill closure of skin)
- Hospital stay(post operative)
- Estimated blood loss ( ebl ) - HGB levels(operative- 4 hours from anasthesia)
研究者
Dr. Elias Castel, Senior Resident Obstetrics and Gynocology
Dr. Elias Castel
Sheba Medical Center