Comparison Of Outcomes Of Vaginal Cuff Closure Versus Laparoscopic Cuff Closure In Total Laparoscopic Hysterectomy In Perimenopausal Women
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
Dr. Dhruva Halani
DMIHER (Datta Meghe Instiute of Higher Education and Research)
