跳至主要内容
临床试验/CTRI/2024/05/067938
CTRI/2024/05/067938尚未招募Phase 3 4

Comparison Of Outcomes Of Vaginal Cuff Closure Versus Laparoscopic Cuff Closure In Total Laparoscopic Hysterectomy In Perimenopausal Women

Dr Dhruva Halani1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Vault dehiscence, hamatoma, cuff related complications

研究概览

简要总结

Hysterectomy is the most common surgical intervention on the female genital tract following

cesarean delivery. Suturing the vaginal cuff is the last stage of TLH. A variety of procedures are available,

depending on the surgeon preference. It is possible to execute interrupted or continuous

suturing, transvaginal cuff closure, and laparoscopic suturing. Due to the complexity of

laparoscopic suturing procedures, the closure of the vaginal cuff is the most challenging

aspect.

Significant drawbacks like cuff dehiscence, intestinal injury, vault bleeding, cuff infection

etc. of the procedure include the need for sophisticated surgical skills, a lengthy learning

curve, and a time-consuming procedure.

In a total of 16 patients undergoing TLH at OBGY department of AVBRH, they will

be simply randomized in a 1:1 ratio to have either laparoscopic or transvaginal closure

of the vaginal cuff, and patients will be kept in the dark about the manner of closure.

Post op cuff-related complications will be followed up after 1 and 2 month

postoperative period like partial cuff disruption, dehiscence, granulation, cuff

infection and yellowish vaginal discharge and will be analyzed.

The present study is also of value for providing new insight in the possible risk

factors for vaginal dehiscence and vaginal cuff complications, because etiological

studies and theories have not yet been supported by substantial evidence.

There is an ongoing need to study the superiority of one vaginal vault suturing

technique over another as the available data is limited.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • Patient having benign indication for TLH (benign indications like fibroid, adenomyosis, AUB)
  • Perimenopausal age group (40-55 years).

排除标准

  • Gynaecological malignancies
  • Unfit for TLH.

结局指标

主要结局

Vault dehiscence, hamatoma, cuff related complications

时间窗: baseline, After 1 and 2 months of followup

次要结局

  • duration of suturing of cuff, surgeon difficulty(baseline)

研究者

发起方
Dr Dhruva Halani
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr. Dhruva Halani

DMIHER (Datta Meghe Instiute of Higher Education and Research)

研究点 (1)

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