Influence of Suture Material Used for Cesarean Section Hysterotomy Closure on the Frequency of Scare Niche Formation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Surgical Success Rate in Relation to Suture Material
研究概览
简要总结
Defective healing of the uterine wound after a Cesarean section (CS) can lead to the formation of a CS niche (CSN). The specific technique used for closure and the type of suture material chosen are often overlooked factors that might contribute to the development of these niches. This study aimed to compare how frequently CSNs occur when the CS hysterotomy is closed using barbed suture material versus conventional vicryl suture material, with assessments primarily done via transvaginal ultrasound (TVS).
The methodology involved closing the CS hysterotomy with a double-layer technique using unlocked continuous running sutures, where the first layer included the decidua and was overlapped by the second. Researchers evaluated several aspects, including the duration and feasibility of the hysterotomy closure, the grade of postoperative pain, and the length of hospital stay. Transvaginal ultrasounds were conducted monthly for three months post-operatively to monitor for CSN development and to gather descriptive measurements of any niches found. The absence of a CSN was considered an indicator of surgical success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 47 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients planned for CS delivery either on emergency or elective bases for singleton fetus in cephalic presentation;
- •Patients were free of
排除标准
- •Patients who signed the written consent to participate in the study and attend the postpartum follow-up for three months.
- •Exclusion Criteria:
- •Patients who had multiple pregnancy;
- •Patients who had fetus in abnormal lie or presentation;
- •Patients who had previous repair of CSN;
- •Patients with uncontrolled DM or hypertension;
- •Patients who had maintained on immunosuppressive therapies, had autoimmune disorders;
- •Patients who refused to sign the written consent were excluded from the study.
研究组 & 干预措施
Vicryl group
In these patients, the Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was conventional multifilament Vicryl.
干预措施: Multifilament vicryl suture material (Other)
Barbed absorbable synthetic monofilament group
In these patients, the Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was barbed suture; which is absorbable synthetic monofilament polydioxanone with bars.
干预措施: Braded Suture material (Other)
结局指标
主要结局
Surgical Success Rate in Relation to Suture Material
时间窗: 3.5 Months
The comparison of the overall surgical success rate, defined by the absence of a Cesarean section niche (CSN), between groups using different suture materials, alongside the quantitative differences in descriptive metrics of any formed CSNs.
次要结局
未报告次要终点
研究者
Basma Sakr
Assistant Professor of Obstetrics & Gynecology, Faculty of Medicine, Benha University
Benha University