Short Term Comparison of Double Layer Continuously Locked Closure of Uterine Incision in Cesarean Section Versus Double Layer Purse String Closure (Turan Technique): A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Cesarean Scar Defect in the Uterine Incisional Line
研究概览
简要总结
Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies, ...) are very important issues. Classically Kerr incision is repaired with continuous locked suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in turn may reduce short and long term complications. For this reason, the investigators aimed to compare two closure techniques.
详细描述
In the clinic, patients undergoing cesarean section that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups (computer-assisted randomization method will be used.) In the first group of patients classical closure method of Kerr incision (double layered continuously locked suturing) will be used. In the second group of patients double layered purse string closure technique will be used. The two groups will be compared after 6 weeks in terms of healing, operation time, blood loss, incision size and incisional scar defect( if present). A physician who does not know the method of closure will evaluate incision size by transabdominal and/or transvaginal ultrasound. The length of the incision and myometrial thickness in Kerr incisional line will be measured and recorded in longitudinal and transverse axis separately. If any incisional scar defect is determined it will be measured and recorded also.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy
- •Term (> 37 weeks) pregnancy
- •Cervical dilatation < 4 cm
- •Kerr incision
- •Age > 18 years old
排除标准
- •Being in active phase of labor
- •Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa )
- •Having a history of uterine surgery (myomectomy, hysterotomy)other than C/S
- •Extension of Kerr incision
- •Multiple pregnancy
- •Maternal diabetes mellitus
- •Maternal connective tissue disease
- •Uterine malformation
- •Uterine fibroids on Kerr incision line
- •Chorioamnionitis
结局指标
主要结局
Cesarean Scar Defect in the Uterine Incisional Line
时间窗: 6 weeks after C/S
A wedge-shaped distortion in the integrity of the uterine incision scar during transvaginal ultrasonographic examination at 6 weeks after C/S was accepted as cesarean scar defect in the uterine incisional line and recorded as primary outcome measure, and two groups will be compared.
次要结局
- Length of Uterine Incision After Suturing(6 weeks after C/S)
研究者
Mehmet Cem Turan
Chief Clinical
Dr. Lutfi Kirdar Kartal Training and Research Hospital