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临床试验/NCT03087565
NCT03087565Unknown不适用

Urinary and Sexual Functions After Subtotal Versus Total Abdominal Hysterectomy

Cairo University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Filling cystometry

研究概览

简要总结

All hysterectomies were performed intrafascially using the clamp-cut-ligate method as described by (Jones, 2003);

Careful examination under anesthesia.

Catheterization by N. 18 Foley's catheter and its balloon Filled with 10-ml saline.A transverse lower abdominal incision (Pfannenstiel incision) ranging from 8-12 cm through which the abdomen is opened in layers.

During subtotal hysterectomy procedure, the corpus is amputated just below the level of the isthmus and then the endocervical canal is electrocoagulated using monopolar electrocautery. The cervical stump is closed using vicryl 0 sutures.

During total hysterectomy procedure, the urinary bladder is dissected off the lower uterine segment of the uterus and cervix by blunt or sharp dissection. Blunt dissection is done using a finger pushed gently against the cervix rather than against the bladder. Sharp dissection using Metzenbaum scissors is performed in patients with previous cesarean sections, with upward traction on the bladder peritoneum and the uterine fundus stretched tightly out of the pelvis, the tips of the Metzenbaum scissors rest lightly on the fascia overlying the cervix with small bites to develop a tissue plane, dissecting the bladder from the anterior cervix.

Revision of all pedicles to ensure hemostasis.

Intraoperative antibiotics (1 gm of a 3rd generation cephalosporin + 0.5 gm metronidazole).

The abdomen is closed in layers; the wound is covered with a sterile dressing. All specimens were sent for pathological examination in the pathology Unit.

详细描述

All hysterectomies were performed intrafascially using the clamp-cut-ligate method as described by (Jones, 2003);

Careful examination under anesthesia.

Catheterization by N. 18 Foley's catheter and its balloon Filled with 10-ml saline.

A transverse lower abdominal incision (Pfannenstiel incision) ranging from 8-12 cm through which the abdomen is opened in layers.

During subtotal hysterectomy procedure, the corpus is amputated just below the level of the isthmus and then the endocervical canal is electrocoagulated using monopolar electrocautery. . The cervical stump is closed using vicryl 0 sutures.

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
None

入排标准

年龄范围
35 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •An age over 35 and below 50 years.
  • •Menstruating women.
  • •No symptomatic uterine prolapse. .
  • •Normal cervical smears.
  • •Benign lesions.
  • •Active sexual life.
  • •Functioning ovaries.

排除标准

  • •Known endometriosis.
  • •Overt neurological or psychiatric disorder.
  • •Candidate for vaginal hysterectomy.
  • •Use of hormone replacement therapy.
  • •Oophorectomy.

研究组 & 干预措施

subtotal hystrectomy

Active Comparator

Careful examination under anesthesia. Catheterization by N. 18 Foley's catheter . A transverse lower abdominal incision (Pfannenstiel incision) . the corpus is amputated just below the level of the isthmus and then the endocervical canal is electrocoagulated using monopolar electrocautery. The cervical stump is closed using vicryl 0 sutures.

Intraoperative antibiotics The abdomen is closed in layers; the wound is covered with a sterile dressing. All specimens were sent for pathological examination .

干预措施: subtotal hystrectomy (Procedure)

Total hyterectomy

Active Comparator

examination under anesthesia. Catheterization by N. 18 Foley's catheter A transverse lower abdominal incision (Pfannenstiel incision) The urinary bladder is dissected off the lower uterine segment of the uterus and cervix by blunt or sharp dissection. Blunt dissection is done . Sharp dissection using Metzenbaum scissors is performed in patients with previous cesarean sections Revision of all pedicles to ensure hemostasis. Intraoperative antibiotics The abdomen is closed in layers; the wound is covered with a sterile dressing. All specimens were sent for pathological examination .

干预措施: Total hystrectomy (Procedure)

结局指标

主要结局

Filling cystometry

时间窗: 6 months after operation

The patient presented with a symptomatically full bladder. She voided spontaneously in a uroflow chair. Maximum flow rate and postvoid residual urine volume were obtained via a transurethral catheter. The microtransducer catheters were connected to the appropriate cables and to the tubing from the water pump. With the patient in the supine position on a urodynamic chair, the abdominal catheter was placed into the vagina. A dual microtransducer 6-French catheter with a filling port was then placed into the bladder. The patient was moved to a sitting position. After the catheters were appropriately placed, the subtraction was checked by asking the patient to cough. Cough-induced pressure spikes should be seen on the Pves and Pabd channels, but not on the true detrusor pressure channel.

Uroflowmetry

时间窗: 6 months after operation

The urinary bladder was filled with normal saline at room temperature with a filling rate 50-100 ml/min. First desire to void and strong desire to void were recorded. Throughout the filling portion of the examination, the patient was asked to perform provocative activities, such as coughing and straining. The external urethral meatus was constantly observed for any involuntary urine loss.

次要结局

  • Sexual functions(6 months after operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maged

Professor

Cairo University

研究点 (1)

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