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临床试验/NCT07308197
NCT07308197
已完成
不适用

Effect of (Posterior Colpotomy First) Technique on the Vaginal Length During Total Abdominal Hysterectomy

Cairo University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年3月30日最近更新:

概览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Total vaginal length

概览

简要总结

the same surgeon performed all of the procedures using the same method. A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied. Group A (traditional technique): the surgeon makes a circumferential incision after initially entering the front vaginal wall. The surgeon performs a circumferential colpotomy at the topmost section of the vagina using the Group B (posterior colpotomy first) approach, entering the vagina via the posterior wall at the uppermost part of the uterosacral ligaments, followed by the left lateral fornix.

Reconstruction of the pelvic floor to ensure hemostasis and good pelvic support. The operative time was assessed by calculating the time between vaginal cuff opening and suturing after uterine artery ligation, As point D on the POP-Q system is omitted after hysterectomy, point C level was reassessed 2 weeks postoperative.

详细描述

the same surgeon performed all of the procedures using the same method. A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied. Group A (traditional technique): the surgeon makes a circumferential incision after initially entering the front vaginal wall. The surgeon performs a circumferential colpotomy at the topmost section of the vagina using the Group B (posterior colpotomy first) approach, entering the vagina via the posterior wall at the uppermost part of the uterosacral ligaments, followed by the left lateral fornix.

Reconstruction of the pelvic floor to ensure hemostasis and good pelvic support. The operative time was assessed by calculating the time between vaginal cuff opening and suturing after uterine artery ligation, As point D on the POP-Q system is omitted after hysterectomy, point C level was reassessed 2 weeks postoperative.

Total vaginal shortening (TVS) and vaginal shortening ratio (VSR) were calculated according to the formulas given below.

TVS=Preoperative VL-Postoperative VL at 3 months. VSP=Preoperative VL-Postoperative VL at 3 months\ Preoperative VL*100

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Ages 40 - 65 years
  • sexually active
  • BMI of 25-40 kg/m2
  • had a fresh abdomen
  • had a benign reason for a hysterectomy (multiple fibroid uterus, adenomyosis, or endometrial hyperplasia).

排除标准

  • Patients who had vaginal and uterine prolapse,
  • subtotal hysterectomy,
  • caesarean hysterectomy in patients with major obstetric hemorrhage (placenta previa, accreta-increta-percreta, uncontrolled postpartum hemorrhage)
  • malignant indications of total abdominal hysterectomy (uterine and cervical carcinoma)

结局指标

主要结局

Total vaginal length

时间窗: after 3 months

calculated according to the formula TVS=Preoperative VL-Postoperative VL

次要结局

未报告次要终点

研究者

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

Ahmed M Maged, MD

Professor

Cairo University

研究点 (1)

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