跳至主要内容
临床试验/NCT05080114
NCT05080114已完成不适用

A Multimodal Concept for Vaginal Cuff Closure by Modification of the Bakay Technique in Total Laparoscopic Hysterectomy: A Randomized Clinical Study

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
148
试验地点
2
主要终点
Total operative time

研究概览

简要总结

Modified Bakay technique offers a novel colpotomy and cuff closure technique for total laparoscopic hysterectomy (TLH), and consists of placing a single continuous running purse-string suture facilitating the cuff closure before colpotomy. The modified Bakay technique adds a standard apical compartment support and has the potential to facilitate the primary healing of the vaginal cuff. This study aimed to compare the surgical and clinical outcomes of the Modified Bakay technique to conventional standard technique in patients undergoing TLH.

详细描述

The basis for minimizing the rate of severe haemorrhage and ureteral injuries, the most serious events related to these steps, is meticulous dissection providing a clear operative field and the skill and experience of the surgeon. In total laparoscopic hysterectomy (TLH), the altered anatomy after the removal of the uterus may cause the retraction of vagina and shifting of neighbouring structures such as bladder and/or bowel to this pouch, thereby, leading to obstruction of the operative field for vaginal cuff closure.

Bakay published his novel colpotomy and cuff closure technique for TLH. It was the first to describe placing a single continuous running purse-string suture facilitating the cuff closure before colpotomy. The main advantage of the technique involved retrieving the safe suture margins required for vaginal cuff closure before the pelvic anatomy was altered by the removal of the uterus.

In addition to this advantage, we modified the technique to achieve a better cuff healing and standardized apical support and the modified Bakay technique (MT) proposes:

i) placing a single continuous running purse-string suture for vaginal cuff closure before the pelvic anatomy is altered by the colpotomy and removal of the uterus;

ii) suspension/plication of USLs (as a well-defined, efficient, concomitant apical support procedure to prevent future vaginal vault prolapse) routinely in each case before colpotomy while the margins of these ligaments and adjacent structures such as ureters are still prominent and pelvic anatomy is not altered; and

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who needed laparoscopic hysterectomy

排除标准

  • Patients with anaesthetic contraindications to laparoscopy
  • premalignant or malignant genital disease
  • prior pelvic and/or abdominal radiotherapy
  • large adnexal masses; large fibroids obscuring the visualization of the cervicovaginal junction
  • Suspicion of malignancy
  • Pelvic organ prolapse Stage >2

结局指标

主要结局

Total operative time

时间窗: Intraoperative, During the surgery

Time interval between the placement and removal of primary trocar, as measured with minutes.

Surgical complications

时间窗: During the surgery, at 7th, 30th and 90th day after the surgery.

Intraoperative and postoperative complications related with the surgery. Any minor and major (e.g., bowel injury, bleeding\>300cc, major vessel injury, bowel injury, haematoma, infection) complications will be classified according to the Clavien-Dindo classification system. This system allows to grade the adverse events between any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention (Grade 1), complications requiring drug treatments (Grade 2), Complications requiring surgical, endoscopic or radiological intervention (Grade 3), Life-threatening complications (Grade 4) and to the death of the patient (Grade 5).

Vaginal length

时间窗: Postoperative, at 90th day after the surgery.

The length of vagina from cervix to introitus, as measured with vaginal measuring ruler by cm.

Patient Satisfaction

时间窗: Postoperative, at 90th day after the surgery.

Patient satisfaction will be measured with Patient Global Impression of Improvement (PGI-I). It is scored as: Very much better (1), Much better (2), A little better (3), No change (4), A little worse (5), Much worse (6), Very much worse (7). Patient reported as Very much better or much better will be regarded as satisfied.

次要结局

未报告次要终点

研究者

发起方
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Uzeyir Kalkan

Principal Investigator

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

研究点 (2)

Loading locations...

相似试验