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临床试验/NCT04216979
NCT04216979Unknown不适用

Palmer's Point Versus The Umbilicus As Routine Primary Entry Site In Gynecologic Laparoscopy

Zagazig University2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2019年12月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
96
试验地点
2
主要终点
complications that occur in using the umbilicus method as the primary entry site in gynecological laparoscopy in comparison with Palmar's point

研究概览

简要总结

we will compare the classic method of using the umbilicus as the primary entry site in gynecological laparoscopy with Palmar's point

详细描述

All these cases will undergo:

  1. History taking Patients are randomly arranged in 2 groups Group (A):- Palmer's point is the primary entry site. The stomach will be emptied of secretions and air following endotracheal intubation. (This is most easily performed using a nasogastric tube.) The left upper quadrant will be inspected for scars and the upper abdomen palpated for hepatomegaly or splenomegaly. A 10-mm incision will be made over Palmer's point. Veress needle first will be used for insufflation and tests of safety will be considered.

A 10-mm port will be held vertically and the layers observed via a 10-mm laparoscope. A gentle rotating action in a vertical direction was used to allow the bladeless tip to separate the tissues.

The layers of the abdominal wall seen at Palmer's point are as follows:

  • skin,
  • subcutaneous fat,
  • external oblique aponeurosis,
  • internal oblique aponeurosis,
  • transversalis muscle fibres,
  • (sometimes) extraperitoneal fat,
  • peritoneum. Once the peritoneum will be breached, the introducer will be carefully removed from the port. The laparoscope will be then reintroduced.

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 (Investigator)

入排标准

年龄范围
10 Years 至 60 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients listed for diagnostic or operative laparoscopy.

排除标准

  • • Splenomegaly
  • Hepatomegaly
  • previous left upper quadrant surgery.
  • midline laparotomy
  • umbilical surgery
  • presence of umbilical hernia

结局指标

主要结局

complications that occur in using the umbilicus method as the primary entry site in gynecological laparoscopy in comparison with Palmar's point

时间窗: 6 months

we will compare the number of participants with vascular or intestinal injuries in both procedures

Time assessed by the difference in using the umbilicus method as the primary entry site in gynecological laparoscopy with Palmar's point

时间窗: 6 months

the surgeon will calculate the time of surgery for similar cases in both groups and will compare between both groups according to the time factor

coordination of the surgeon movement by the difference in using the umbilicus method as the primary entry site in gynecological laparoscopy in comparison with Palmar's point

时间窗: 6 months

questionnaire will be done to ask the surgeon about the degree of coordination and smoothness of using the surgeon his both hands in laparoscopy

次要结局

未报告次要终点

研究者

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

basem mohamed hamed khalil

lecturer of obstetrics and gynecology/ MD ob/gyn

Zagazig University

研究点 (2)

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