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临床试验/NCT05296928
NCT05296928已完成不适用

The Effect of the Umbilicus and Sub-umbilicus Incisions Used in Laparoscopic Gynecological Surgeries on the Postoperative Pain Score

Baskent University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
postoperative pain score

研究概览

简要总结

In this study, it was aimed to compare the embryonic route, the umbilicus, and the sub-umbilicus incision in terms of postoperative pain scoring. For this purpose, in laparoscopic hysterectomies performed for benign reasons, it is planned to measure the pain score at the 8th hour and 1st day postoperatively in the umbilicus and subumbilical incision. Visual analog scoring system will be used for pain scoring.

详细描述

In this prospective randomized study, Baskent University Adana Dr. Turgut Noyan Application and Research Center for benign reasons (myomas that cause abnormal uterine bleeding, resistant to medical and hysterescopic surgery, treatment-resistant adenomyosis in which the uterus reaches 12 weeks of gestation, recurrent endometrial hyperplasia, endometriosis, stage 1 endometrial cancers that only underwent hysterectomy) in laparoscopic hysterectomies; at the entrance to the abdomen, it is planned to apply the umbilicus, which is the anatomical route, to some of the patients, and to the other part of the sub-umbilicus incision. It will be compared in terms of pain score on the 8th hour and 1st day after surgery. The minimum quorum for each group was determined by calculating 41 and taking a total of 82 patients. The simple randomization technique will be applied in the distribution to the study sets. Based on the studies, it is thought that the anatomical path may be less painful.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Malign disorders
  • Uterus larger than 12 weeks of gestation

结局指标

主要结局

postoperative pain score

时间窗: 8 hour

The umbilicus, which is the embryonic pathway used in laparoscopic surgery, is expected to cause less postoperative pain.In the Visual Analog Score to be used as the pain measurement criterion, '0' indicates no pain, while '10' defines the most severe pain.

次要结局

  • postoperative pain score after 24 hour(24 hour)

研究者

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

Didem Alkaş Yağınç

Principal Investigator

Baskent University

研究点 (1)

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