Efficacy of At-origin Uterine Artery Ligation Compared to Conventional Post-cornual Pedicle Ligation in Reducing Operative Time During Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Operative time in minutes
研究概览
简要总结
The aim of the current study is to compare between the uterine artery ligation at its origin at the beginning of the operation and the conventional method after cornual pedicle regarding their efficacy to minimize operative time in patients undergoing total laparoscopic hysterectomy.
详细描述
- Approval of the study protocol will be sought from ASUMH ethical committee.
- The patients will be enrolled from the outpatient gynecology clinic of ASUMH.
- History, examination and routine investigations will be done to identify eligible patients.
- Written informed consent will be sought from the patients after proper counseling.
- Randomization: It will be a quasi-randomized clinical trial.
- Allocation: through "Alternation" method. Eligible patients will be randomized into one of the two study groups, where odd numbered patients (ex: patient number 1, 3, 5, etc. ...) will be allocated to group (A) and even numbered patients (ex: patient number 2, 4, 6, etc. ...) will be allocated to group (B) till full-filing the sample size. Before the operation, the patient will be allocated according to her number.
- Blinding: the patient will not be aware of the method used (either the conventional method or the At-origin ligation method) (single blinded).
- Patients who are randomized to group A will undergo TLH in the conventional method as follows:
Positioning:The patient will be positioned in dorsal decubitus, under general anesthesia, with oral tracheal intubation. The legs will be positioned in 30°flexion; the arms along the body, and the buttocks extending slightly over the edge of the surgical table. The bladder will be catheterized. The surgeon will be positioned to the left of the patient, the primary assistant on the right, and the second assistant is responsible for uterine manipulation.
Uterine Cannulation: Uterine cannulation will be performed using uterine manipulator. Hysterometry will be performed, the cervix will be dilated using Hegar dilators if needed, and the manipulator will be inserted under direct vision into the cervix.
A Veress needle will be inserted at the umbilicus or supraumbilical site depending on the size of the uterus and abdomen will be insufflated with carbon dioxide at initial pressure of 20 mm Hg and maintenance at 15 mm Hg. A 10 mm trocar will be inserted blindly, and 10 mm telescope will be introduced through this port. Uterus and the adnexa will be visualized. Three additional 5mm ports are introduced: one along the left spino-umbilical line at the junction of medial 2/3rd and lateral 1/3rd, second port at right angles to the previous port, and a third 5 mm port placed around 2 cm below and to the right of umbilicus. The entire abdomen is surveyed before starting the procedure. The size of the uterus, presence of myomas, and adnexa and course of ureters are visualized (Poojari et al., 2014).
Coagulation and section of round ligaments will be performed about 2 to 3 cm from the pelvic wall using blunt tip laparoscopic sealer LigaSure COVIDIEN (5mm-37cm) with average of sealing cycle of 2 to 4 seconds and 40 watts , followed by opening the anterior leaflet of the broad ligament to the vesico-uterine peritoneal reflection, coagulation and section of the infundibulo-pelvic ligament (total hysterectomy with bilateral adnexectomy) or of the uteroovarian ligament and the fallopian tubes (total hysterectomy). Then opening the posterior leaflet of the broad ligament to the cervix, opening of the vesico-vaginal space and dissecting the bladder downwards will be done (Poojari et al., 2014).
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 (Participant)
入排标准
- 年龄范围
- 35 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age group (35-70 years old).
- •Women consenting to have a total laparoscopic hysterectomy.
排除标准
- •Patients with relative contraindication to general anesthesia (e.g. chronic liver cell failure)(All laparoscopic procedures are done under GA).
- •Patients with contraindication to laparoscopic surgery (e.g. severe cardio-pulmonary dysfunction).
- •Bleeding tendency (e.g. anticoagulants, platelets disorders)(will affect the blood loss measurement)
- •Body mass index more than 35 Kg/m2(not suitable for laparoscopic surgeries as obesity affects airway pressure )
- •Uncorrected anemic patients (Hemoglobin < 10 gm. /dl).(will affect the outcomes eg :
- •Blood transfusion , hospital stay ... etc )
结局指标
主要结局
Operative time in minutes
时间窗: Intraoperative (once for each patient starting from port insertion till disconnecting the uterus from the vagina .)
starting from port insertion till disconnecting the uterus from the vagina
次要结局
- Hospital stay (in days)("through study completion, an average of 1 year".)
- Complications(during the procedure,immediately after the procedure .)
- Blood loss in millimeters(Intraoperative (once for each patient at the end of the operation .))
- postoperative pain measured using visual analogue score.(6 hours postoperative - 12 hours postoperative)
研究者
Yasser Elrefaey
Assistant Lecturer of obstetrics and gynecology
Ain Shams University
