Efficacy and Safety of V-LocTM 180 Barbed Sutures Compared to Polyglactin 910 Vicryl in Laparoscopic Isthmocele Repair: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Post-operative residual myometrial thickness
研究概览
简要总结
To evaluate postoperative outcomes in patients with isthmocele undergoing laparoscopic repair, comparing the efficacy of V-LocTM 180 and Polyglactin 910 Vicryl sutures.
Patients were randomized to undergo laparoscopic isthmocele repair using one of the following suture materials: (1) V-LocTM 180 or (2) Polyglactin 910 Vicryl.
详细描述
The global rise in cesarean section (CS) rates has led to an increased incidence of associated complications, presenting new challenges in gynecological practice. One of these complications is a cesarean scar defect, also known as isthmocele, which manifests as a pouch-like structure at the site of the previous CS scar. This defect often results in the accumulation of menstrual blood, inflammatory cells, and mucus, leading to symptoms such as postmenstrual bleeding, pelvic pain, and dyspareunia. Furthermore, isthmocele has been implicated in secondary infertility due to the inflammatory changes it induces in the endometrium. Additionally, the presence of an isthmocele increases the risk of complications in future pregnancies, including cesarean scar ectopic pregnancy, uterine rupture, and placenta accreta spectrum disorders.
Diagnosis of isthmocele relies on imaging modalities such as transvaginal ultrasound (TVUS), sonohysterography (SHG), or hysteroscopy. While asymptomatic cases generally do not require intervention, symptomatic patients may benefit from medical or surgical treatment. Due to limited evidence supporting medical therapy, surgical intervention has become the preferred approach, particularly for patients desiring future fertility. Various surgical techniques, including hysteroscopic, laparoscopic, vaginal, laparotomic, and combined procedures, have been proposed for isthmocele repair. Among these, laparoscopic isthmocele repair is favored for patients with fertility concerns as it enables complete excision of the defective myometrial tissue and reconstruction of the uterine wall.
Despite the advantages of laparoscopic isthmocele repair, no universally accepted cutoff value for residual myometrial thickness dictates surgical candidacy. Previous studies have suggested that laparoscopic repair is a safer and more practical option for cases with significant myometrial loss (>80%). However, there is limited data on the impact of different suture materials used in laparoscopic repair on postoperative outcomes.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The study will include women aged 18-45 years who present with symptomatic isthmocele.
- •Participants must have a residual myometrial thickness of less than 2.5 mm.
- •Participants must desire future fertility.
排除标准
- •Age below 18 or above 45 years
- •Atypical endometrial cells or cervical dysplasia on cytology
- •Asymptomatic isthmocele
- •Candidacy for hysteroscopic surgery
- •Cervical or pelvic infections
- •Cervical dilation of 4 cm or more (emergency surgery)
- •Conditions impairing tissue healing, such as:
- •Type 1 or Type 2 diabetes mellitus
- •Hematologic disorders associated with bleeding diathesis
- •Contraindications for spinal or general anesthesia
- •Continuous use of oral contraceptives (OCPs) or GnRH agonists that affect menstrual cycles
- •Hydrosalpinx communicating with the uterine cavity
- •Intrauterine device (IUD) in place
- •Known connective tissue disorders
- •Menstrual irregularities:
- •Cycles longer than 35 days
- •Cycle variations of 2 weeks or more
- •Ongoing pregnancy
- •Presence of structural abnormalities such as:
- •Uterine or cervical polyps
- •Submucosal fibroids
- •Other similar conditions
- •Residual myometrial thickness > 2.5 mm
- •Retained placental tissue
- •Suspected malignancies
- •Uterine anomalies
- •Immunosuppressive diseases
研究组 & 干预措施
laparoscopic isthmocele repair using V-LocTM 180 barbed suture
The isthmocele area will be sutured using V-LocTM 180 barbed suture in a continuous, non-locked fashion. The repair was performed using a two-layer closure technique, ensuring precise reapproximation of the myometrial edges without breaching the uterine cavity, followed by closure of the serosal edges.
干预措施: Laparoscopic isthmocele repair using V-LocTM 180 barbed suture (Procedure)
laparoscopic isthmocele repair using Polyglactin 910 Vicryl sutures
The isthmocele area will be sutured using Polyglactin 910 Vicryl sutures in a continuous, non-locked fashion. The repair was performed using a two-layer closure technique, ensuring precise reapproximation of the myometrial edges without breaching the uterine cavity, followed by closure of the serosal edges.
干预措施: Laparoscopic isthmocele repair using Polyglactin 910 vicryl suture (Other)
结局指标
主要结局
Post-operative residual myometrial thickness
时间窗: 1 year
Ultrasonographic evaluation will be performed in the 12th postoperative month to measure residual myometrial thickness and assess the anatomical success of the repair.
次要结局
- Patient satisfaction and quality of life(1 year)
- 3.Patient satisfaction(1 year)
研究者
Ozan Karadeniz
MD
Başakşehir Çam & Sakura City Hospital