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临床试验/NCT07473934
NCT07473934尚未招募不适用

Direct Trocar Versus Verres Needle Entry at Gynecologic Laparoscopy in Previous Scarred Abdomen: A Randomised Clinical Trial

Assiut University0 个研究点目标入组 88 人开始时间: 2026年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
88
主要终点
total operative time

研究概览

简要总结

Laparoscopy is a minimally invasive technique employed for diagnostic and surgical approaches. Minimally invasive technique compared to laparotomy offer the advantages such as reduced hospital stay, lower morbidity, reduced pain, and faster recovery(1). It has become the primary approach for diagnosing and treating gynecological diseases, favored for both benign and malignant conditions involving the uterus, ovaries, and fallopian tubes, as well as for diagnostic evaluations in cases like chronic pelvic pain and infertility (2).

Access to the abdomen is the main challenge of laparoscopic surgery. To minimize entry-related injuries like, subcutaneous emphysema, gastrointestinal tract perforation, and minor and major vascular injury for creation of pneumoperitoneum. Several techniques, instruments, and approaches have been introduced. Despite widespread awareness of laparoscopic entry guidelines, considerable variation in the techniques was adopted in clinical practice(3) However, the initial step of accessing the abdominal cavity presents inherent challenges, especially in patients with previous cesarean sections, whose abdominal anatomy may be altered by adhesions or scar tissue(4).

Several methods are used for laparoscopic entry. The most common techniques include Veress needle insertion (VNI), direct optical trocar entry, direct trocar insertion (DTI), and the Hasson technique(5).

VNI is the most common method that is used nowadays despite its slow insufflation rates and fatal complications .Veress needle can be introduced periumbilical or in the left hypochondrium. The Palmer's point is a favoured option for periumbilical Veress needle insertion. The point is located 3 cm below the left costal border at the mid-clavicular line. Many studies have found that there are safer and more effective alternate procedures for peritoneal access in patients following abdominal surgery(6).

The DTI technique requires the advancing of the trocar with a blind twisting motion into the peritoneum after the elevation of the anterior abdominal wall with one hand or with towel clamps. If visual inspection with the camera confirms proper placement, pneumoperitoneum is established with the insufflation of a gas. VN requires the insertion and retraction of a spring-loaded needle with an external diameter of 2 mm. When the tip of the needle penetrates through tissues and enters the peritoneal cavity, the inner stylet springs forward. Then, carbon dioxide is insufflated creating a pneumoperitoneum(7).

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • previous abdominal and pelvic surgeries
  • patients age > 19 years

排除标准

  • Massive bowel distension

研究组 & 干预措施

Verres Needle Entry

Active Comparator

干预措施: Veress Needle Entry (Procedure)

Direct Trocar group

Active Comparator

干预措施: Direct Trocar (Procedure)

结局指标

主要结局

total operative time

时间窗: baseline

total length of the procedure/total operative time (in minutes)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sedek Ahmed Sedek

residant doctor at Assiut university hospital

Assiut University

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