Total Laparoscopic Hysterectomy(TLH) With Prior Uterine Artery Clipping Versus Conventional Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The total blood loss
研究概览
简要总结
A randomized controlled trial was done on 30 women planned for TLH, and divided into two groups; group A includes women that will be subjected to conventional TLH, and group B includes women that will be subjected to TLH with prior uterine artery clipping at its origin. Both grouped will be compared regarding the blood loss, operation time, intraoperative complications and post-operative follow-up
详细描述
Patients will be randomized into 2 groups:
Group (A): Women who will be subjected to conventional Total laparoscopic hysterectomy Group (B): Women who will be subjected to Total laparoscopic hysterectomy with prior uterine artery clipping at its origin.
Intraoperative:
Pre-Anesthesia medications: All patients will receive intravenous antibiotics 30 minutes before induction of anesthesia {Cefotaxime 1gm (Claforan®-EIPICO) & Metronidazole 500 mg (Flagyl®-rPr)}.
- All patients will be positioned in the dorsal lithotomy position
- Examination under anesthesia will be done to assess uterine size, mobility and the presence of any gross adnexal pathology.
- A bladder catheter will be placed to empty the bladder and to monitor the urine output.
- A uterine manipulator (V care cup®) will be placed through the cervix to manipulate the uterus.
- The surgeon will stay on the left side of the patient, the assistant on the right side and the scrub nurse in between the patient's legs for uterine manipulation.
- A small vertical incision will be made into the depth of the supra umbilicus about 0.5 cm length;
- The closed method will be employed where the Veress needle will be inserted vertically into the supra -umbilical incision.
- Hanging drop test will be done to ensure proper needle placement through attaching an open syringe filled with saline to the Veress needle and observing the drop.
- Insertion of 10 mm trocar through the supra umbilical incision and then the operating laparoscope will be inserted through the supra umbilical port.
- CO2 Insufflation will be started to induce pneumoperitoneum till pressure reached 20 mmHg and reduced to 15 mm afterwards.
- Two 5 mm lower quadrant ancillary trocars will be inserted lateral to the inferior epigastric arteries under direct laparoscopic vision above the pubic hairline.
- Another 10 mm trocar will be inserted 3cm above the left lower ancillary trocar under direct vision.
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
- Single (Investigator)
盲法说明
The study design precluded neither participants nor the surgeons will be blinded, only data analyzer will be blinded to each allocation group" single blinded study". However, the outcomes of the study are objective not subjective and will not be affected by lack of blinding.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• Benign conditions as indications for hysterectomy (e.g., dysfunctional uterine bleeding, adenomyosis and uterine fibroids) provided that the uterus size is no more than 14 weeks.
排除标准
- •• Obese patients i.e., BMI > 35 k.g\m
- •Suspected extensive pelvic adhesions based on previous history and examination.
- •Factors which may delay vaginal vault healing as uncontrolled diabetes, prolonged corticosteroid therapy or advanced liver diseases.
- •Inability to give adequate informed consent to participate in the study.
- •Previous ureteric surgery
- •Previous midline incision
- •Previous uterine artery embolization.
- •Known tubo ovarian pathology requiring primary laparotomy, e.g. large adnexal masses.
- •Conditions interfering with laparoscopic surgery e.g. significant cardiopulmonary disease.
- •Large uterus interfering with TLH (size >14 gestational weeks).
- •Broad ligament and cervical myoma hindering access to the lateral pelvic wall
- •Having endometriosis grade III orIV according to ASRM classification.
- •. Having 2nd or 3rd degree uterine descent
结局指标
主要结局
The total blood loss
时间窗: start time is the insertion of 10 mm telescope trocar end-time is the removal of all trocars
Blood loss (mL): The total blood loss will be from the suction apparatus
次要结局
- intraoperative or postoperative complications(during the Laparoscopy and during the hospital stay (24 hours postoperative)
研究者
Yasmeen Ahmed Mohamed Mohamed Taha
The principal investigator
Ain Shams Maternity Hospital