Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

赞助:

合作者:

信息的提供 (责任方):

Hamdy Bakry Alqenawy，Ain Shams University

追踪信息

首次提交日期 ^ICMJE

September 10, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

October 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Operative time[ Time Frame: duration of surgical procedure ]

Total operative time (minutes) for LH versus VH; from introduction of the first laparoscopy port or vaginal incision, till suturing the vaginal vault.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Blood loss[ Time Frame: intra-operative ]
Blood loss (mL): by measuring suctioned blood (subtracting irrigation volumes), Weighing sponges (weight difference of soaked and dry surgical gauzes, 1 g ≃ 1 mL), or according to Gross (1983) formula (mL)
Blood transfusion[ Time Frame: 24 hours post-operative ]
Need for blood transfusion
Proportion of successful vaginal opportunistic salpingectomy[ Time Frame: intra-operative ]
Proportion of patients with successful vaginal opportunistic salpingectomy or salpingo-oophorectomy compared to laparoscopic approach, and factors for non completion
Surgical complications[ Time Frame: intra-operative ]
Surgical complications: visceral or vascular injuries, vaginal cuff haematoma or dehiscence
Post-operative pain assessed using visual analogue scale for pain intensity[ Time Frame: first 24 hours post-operative ]
Post-operative pain: assessed using visual analogue scale for pain intensity at 2, 6 and 24 hours post-operative
Febrile morbidity[ Time Frame: first 24 hours post-operative ]
Post-operative fever (temperature assessed in degrees Celsius)
Change in serum markers for inflammation[ Time Frame: first 24 hours post-operative ]
Inflammatory response serum markers compared pre- and 24-h postoperatively (e.g. C-reactive protein or interleukin-6 according to availability)
Hospital-stay[ Time Frame: 1 week ]
Post-operative hospital-stay (hours)
Healthcare costs[ Time Frame: 1 week ]
Healthcare costs (EGP), including consumables, medications, and admission fees.

描述性信息

简略标题 ^ICMJE

Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

正式标题 ^ICMJE

Laparoscopic Versus Vaginal Hysterectomy for Benign Gynaecological Disease in Ain Shams University Maternity Hospital: A Randomized Clinical Trial

简要概况

This study is designed to compare laparoscopic and vaginal hysterectomy in women with benign gynaecological disease in Ain Shams University Maternity Hospital.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Procedure: LH
Laparoscopic hysterectomy (TLH or LHa)
Procedure: VH
Vaginal hysterectomy

研究工具

Experimental: Group L
Active Comparator: Group V

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

October 2020

预计主要完成日期

October 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Women undergoing hysterectomy for benign gynaecological disease (e.g., dysfunctional uterine bleeding, adenomyosis, fibroids). Exclusion Criteria: Women with: - known tubo-ovarian pathology requiring primary laparotomy, e.g. large adnexal masses - known neoplasia requiring pelvic lymphadenectomy - pelvic organ prolapse requiring additional procedures, e.g., uterine procidentia (complete prolapse), enterocoele - conditions interfering with laparoscopic surgery, e.g. cardio-pulmonary disease, obesity (BMI 30 kg/m2 or more) - large uteri interfering with vaginal hysterectomy (size >16 gestational weeks)

性别

参与研究的性别:

Female

年龄

最小年龄：N/A ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Hamdy Bakry Alqenawy，Ain Shams University

研究赞助商 ^ICMJE

Ain Shams University

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

Ain Shams University

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

请使用微信扫码报名