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Total Laparoscopic Hysterectomy With Prior Uterine Artery Cauterization From the Origin Versus Conventional Laparoscopic Hysterectomy

2026年5月15日 更新者:Hadeer Ali Alashry Mohamed、Kafrelsheikh University
The main goal of this study is to compare between total Laparoscopic hysterectomy proceeded by Uterine artery cauterization at its origin and conventional total Laparoscopic hysterectomy regarding: bleeding , operative time , intra operative time and follow up post operative.

研究概览

详细说明

The most common non-pregnancy-related gynecological procedure performed for women is a hysterectomy. (Uwais et al,. 2024 )In Germany, the incidence of hysterectomy ranges from 2.13 to 3.62/1000, while in the United States, it is 5.4/1000. In the US, about 600,000 hysterectomy surgeries are carried out each year. (Harvey et al ,. 2022 ) Fibroids, adenomyosis, endometriosis, dysfunctional uterine bleeding, uterine prolapse, and premalignant and malignant lesions are among the many indications for a hysterectomy. (Singh et al ,. 2024 ) Traditionally , hysterectomy has been done abdominally or by vaginal route . In the present era , Laparoscopic hysterectomy has recently received a considerable respect as a favourable hysterectomy technique . ( Bartels et al ,. 2020 ) Laparoscopic hysterectomy is a safe , workable technique , provides minimal post operative discomfort, shorter hospital stay , rapid convalescence , early return to daily activities. ( Pepin , K. et al ., 2020 ).

Selection of route of hysterectomy can be influenced by size , shape of the vagina and uterus, accessibility of the uterus, extent of extra uterine disease , surgeon experience, available hospital support, whether the case is emergent or scheduled and preference of the informed patient . ( Panda et al ,. 2022 )

.As Laparoscopic surgery becomes more advanced and widely applied, the absolute contraindications to laparoscopy are diminishing . Patient limitations to Laparoscopic surgery can be both anatomical and physiological .

Adverse anatomical limitations include difficult access to the abdomen , obliteration of the peritoneal space , organomegaly , intestinal distension and the potential for cancer dissemination.

The major physiological obstacles to safe Laparoscopy include increased intracranial pressure, abnormalities in cardiac output and gas exchange in the lung , chronic liver disease and coagulopathy . These anatomical and physiological conditions were formerly considered absolute contraindications to laparoscopy, they are now considered only relative contraindications.( Madhok et al ,. 2022 )

. The uterus receives the majority of its blood supply from the uterine artery, a branch of the internal iliac artery. In order to reach the uterine cervix, the uterine artery is first found 2.5 cm lateral and superior to the ureter before crossing it anteriorly to its medial side .( Selcuk I et al ,. 2018).

The ureter is more susceptible to injury during oophorectomy and hysterectomy because of its close relationship to the ovary, where it lies beneath the insertion of the infundibulopelvic ligament at the pelvic brim, and its relationship to the uterine artery, where it passes inferior to the uterine artery.( Lescay et al ,. 2024 )

Although total Laparoscopic hysterectomy (TLH ) is generally safe .There is a potential risk of complications may occur . Excessive blood loss during TLH is still an issue which need blood transfusion especially in case of large uteri . ( Saad _ Naguib M et al , .2022) .

During TLH, the uterine arteries (UAs) must be closed effectively.Closing UAs at the uterine level or at the origin from the internal iliac artery are the two main options . The decision is solely based on the preferences and opinions of the surgeon.( Uccella et al ,. 2021) .

There is a shortage in data that compare two techniques , therefore , Current study will be conducted to compare feasibility, duration of the surgery , estimated blood loss , post operative complications during conventional Laparoscopic hysterectomy versus early Uterine artery cauterization at its origin .

研究类型

介入性

注册 (估计的)

44

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Mustafa Farag Ellakany, Lecturer
  • 电话号码:+2 01016083210

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria: Age of the patient is more than 35 y . Non malignant pathologies including fibroids, endometrial hyperplasia, Dysfunctional Uterine bleeding not responding to medical treatment.

Good general condition of the patient ( American society of Anesthesiologists "ASA" score 1 , 2 , 3 ( Horvath et al ,. 2021) .

Uterine size is less than 20 weeks by fundal level . -

Exclusion Criteria:Age of the patient is less than 35 y . Gynecological malignancies . Contraindications for laparoscopy as any medical condition worsens by peumo peritoneum or Trendelenburg position as severely compromised cardiopulmonary status .

Patients with American society of Anesthesiologists score 4 or more . ( Horvath et al ,. 2021) Uterine size is more than 20 weeks by fundal level .

-

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Total Laparoscopic hysterectomy with prior uterine artery cauterization from the origin
Total Laparoscopic hysterectomy with prior Uterine artery cauterization from the origin take less time and cause less bleeding
Total Laparoscopic hysterectomy with prior Uterine artery cauterization from the origin to arm 1
实验性的:Conventional Total Laparoscopic hysterectomy
Conventional Total Laparoscopic hysterectomy may cause more blood loss and take more time
Conventional Laparoscopic hysterectomy
Total Laparoscopic hysterectomy with ligation of uterine artery beside uterus is considered conventional and may cause more blood loss and take more time

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Is to compare peri operative blood loss by counting amount of blood in ml drained by suction , operation time between Conventional TLH and TLH with prior occlusion to UAs at its origin
大体时间:24 hours after surgery
Is to compare peri operative blood loss by counting amount of blood in ml drained by suction , operation time between Conventional TLH and TLH with prior occlusion to UAs at its origin
24 hours after surgery
Is to compare peri operative blood loss , operation time between Conventional TLH and TLH with prior occlusion to UAs at its origin
大体时间:One week after surgery
Is to compare peri operative blood loss , operation time between conventional TLH and TLH with prior Uterine artery occlusion
One week after surgery

次要结果测量

结果测量
措施说明
大体时间
Post operative pain , difference in Hemoglobin level in mg /dl pre and post operative, frequency of post operative hematoma in cm detected by us at vaginal vault and ureteric complications
大体时间:24 hours postoperative
Post operative pain , difference in Hemoglobin level in mg / dl pre and post operative, frequency of post operative hematoma in cm detected by us at vaginal vault and ureteric complications
24 hours postoperative

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月15日

初级完成 (估计的)

2027年5月15日

研究完成 (估计的)

2027年6月15日

研究注册日期

首次提交

2025年7月9日

首先提交符合 QC 标准的

2026年5月15日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月15日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • Total Laparoscopic hysterectom

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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