Effect of Single Layer Versus Double Layer Suturing on Healing of Caesarean Uterine Scar: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The residual myometrial thickness at 3 months by trans vaginal us.
研究概览
简要总结
To assess the effect of single versus double layer closure of caesarean scar on the residual myometrium on the short & intermediate term.
详细描述
Caesarean section is the fetal delivery through an open abdominal incision (laparotomy) and an incision in the uterus (hysterotomy). The first caesarean documented occurred in 1020 AD, and since then, the procedure has evolved tremendously. It is now the most common surgery performed in Egypt, with over 1 million women delivered by caesarean every year. The caesarean delivery rate worldwide rose from 5% in 1970 to 31.9% in 2016 An optimal uterine closure should provide better scar healing. Closure of the uterine incision needs to be considered with regards to benefit and potential harm in order to offer the best available surgical care to women undergoing caesarean section. Surgical suturing technique and mechanical tension affecting the surgical wound are the most important factors related to the incisional integrity, especially for minimizing postoperative caesarean delivery scar defects .
Currently, a low-transverse incision is the preferred method of hysterotomy during caesarean delivery. This incision has traditionally been repaired with a two-layer closure. A two-layer closure usually involves a continuous, unlocking layer of absorbable suture with an addition of adds muscular fold to cover the first layer. Studies showed that women whose uterine incisions have been closed by double-layer following caesarean section experienced greater advantages in terms of residual myometrium thickness, healing ratio (residual myometrium thickness/adjacent myometrium thickness), and dysmenorrhea .
The safe cut off thickness of scar in post LSCS uterus varies from 1.5 to 3.5 mm; the thinning of the site is the cause of worry of dehiscence scar or rupture in next pregnancy. Closure of the uterine incision is a key step in caesarean delivery, correct approximation of the cut margins is not guaranteed .
This may be possibly due to edges getting overlapped; and, after remodelling and the process of the healing, thickness of the site of incision is significantly reduced. There is also a very high possibility of inter surgeon variability. It was felt that if there is a suturing technique which ensures correct approximation of all the layers with nil or minimal possibility of inters operator variability, there will not be any thinning of lower segment caesarean section LSCS site, and scarred uterus repaired in this manner will be able to withstand the stress of labor in future .
A growing body of evidence suggests that the surgical technique for uterus closure influences uterine scar defect, but there is still no consensus about optimal uterus closure. Some techniques seem to have the potential to decrease the risk of short-term complications, while others have long-term benefits, such as reduced risk of uterine rupture. Some maternal symptoms are related to the appearance of the uterine scar, and more specifically to a niche in the caesarean scar as a surrogate marker. niche is defined as an indentation in the myometrium of ≥2 mm in depth and is detectable by transvaginal ultrasound (TVUS), preferably with contrast to limit false negatives. Complications in subsequent pregnancies, including uterine rupture and placenta accreta spectrum disorders, are associated with thin residual myometrium .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 50 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy.
- •Gestational age between 37 completed weeks to 42 weeks.
- •Patients undergoing elective primary caesarean section.
排除标准
- •Pregnant women who declined to participate.
- •History of uterine surgery (e.g. hysterotomy, myomectomy, perforation, caesarean section).
- •Presence of maternal disease (diabetes mellitus, connective tissue disorders, uterine malformations).
- •Women Diagnosed with Placenta Accreta Spectrum during the current pregnancy
- •Multiple pregnancy.
- •Chorioamnionitis.
结局指标
主要结局
The residual myometrial thickness at 3 months by trans vaginal us.
时间窗: 3 months
Evaluation of the residual myometrial thickness at 3 months after the caesarean section by trans vaginal ultrasonography saline infusion sonohystrography will be done ( in a full bladder patients , Casco speculum will be inserted into vagina followed by insertion of soft non balloon tip catheter 5 French into uterus through vagina then cervix. The speculum was extracted to insert the transducer, 5-10 cc of saline was inserted through the catheter into the uterine cavity to allow the lining of the uterus to be imaged clearly on the ultrasound screen and showed any endometrial abnormality,. Residual myometrial thickness "RMT" is the distance between the tip of the hypo echoic triangle and the surface of anterior uterine wall measured by mm.)
次要结局
未报告次要终点
研究者
Sara AbdelRazek Ramadan Hamad
The principal investigator
Ain Shams Maternity Hospital
