Comparison Between Laparoscopic Versus Transvaginal Cuff Closure After Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 1. number of cases ofVaginal cuff dehiscence
研究概览
简要总结
It is still debatable whether that the transvaginal approach to vault closure or laparoscopic suturing are associated with lower risks of vaginal cuff complications .
This study aims to compare the two approaches of closure of the vaginal cuff at the end of total laparoscopic hysterectomy as regards the vaginal cuff complications .
详细描述
All the women will subject to:
Preoperative Assessment including:
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Detailed history taking including age ,parity, medical ,surgical history .
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Physical examination:
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General examination including the body mass index .
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Abdominal examination including presence of previous scars, uterine size , any tenderness and presence of palpable masses .
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Pelvic examination: including uterine size, any adnexal mass and tenderness .
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Preoperative investigation:
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A preoperative trans-vaginal ultra- sonography to assess the volume of the uterus, gross uterine pathology and any adnexal pathology.
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The preoperative laboratory investigation: hemoglobin percent and haematocrit value, blood grouping ,liver and kidney function tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
neither the paticipant nor the investigator knew type of vaginal cuff closure
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients candidate for total laparoscopic hysterectomy :
- •Uterine size <12 weeks.
- •Having no severe endometriosis.
- •Having descent of no more than 1st degree of uterus.
- •Non-malignant conditions.
- •Completion of the entire procedure by laparoscopic approach up to colpotomy.
- •Benign conditions as indications for hysterectomy.
排除标准
- •Obese patients i.e., BMI > 30 k.g\m
- •Suspected extensive pelvic adhesions . 3) Factors which may prolong wound healing as uncontrolled diabetes, ,prolonged corticosteroid therapy ,advanced liver diseases.
- •Inability to express adequate informed consent to participate in the study.
结局指标
主要结局
1. number of cases ofVaginal cuff dehiscence
时间窗: 3 months
Any separation at the level of the vaginal vault.
次要结局
- number of cases with vaginal hematoma(3 months)
- number of cases with vaginal infection(3 months)
研究者
amr saad mahmoud
assistant lecturer
El-Galaa Military Medical Complex