跳至主要内容
临床试验/CTRI/2025/07/091496
CTRI/2025/07/091496尚未招募不适用

Robotic versus laparoscopic hysterectomy Comparison of perioperative outcomes in benign gynecological diseases

Max Smart1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
102
试验地点
1
主要终点
To compare early surgical outcomes between robotic and laparoscopic hysterectomy.

研究概览

简要总结

Hysterectomy is one of the commonest gynecological procedure done for benign conditions apart from malignant conditions. There is rising trend of minimally invasive surgeries worldwide. Robotic hysterectomy can be safely performed and has perioperative outcomes equivalent to Laparoscopic hysterectomy and superior to Total Abdominal hysterectomy.  Robotic hysterectomy is an alternative tool for minimally invasive hysterectomy. However there is a relative dearth of Indian literature with regard to this modality. More studies are required to assess patient safety and identify specific sub groups who would benefit from robotic approach.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 89.00 Year(s)(—)
性别
Female

入选标准

  • All the patients above the age of 40 years undergoing laparoscopic hysterectomy or robotic hysterectomy for benign gynecological diseases and willing to be a part of the study will be included.

排除标准

  • The patient who are not willing to be a part of the study will be excluded.
  • Patients with malignant gynecological disease.
  • Patient undergoing additional surgeries like cholecystectomy, breast surgery.
  • Patients with coagulation disorders.
  • Patients with severe endometriosis (stage 3 and 4).

结局指标

主要结局

To compare early surgical outcomes between robotic and laparoscopic hysterectomy.

时间窗: 8 months

To compare following between robotic and laparoscopic hysterectomy

时间窗: 8 months

- Intra operative complications

时间窗: 8 months

- Conversion to open surgery

时间窗: 8 months

- Estimated blood loss

时间窗: 8 months

- Post operative pain as per visual analogue scale and need for extra analgesics

时间窗: 8 months

- First gas discharge

时间窗: 8 months

- Hospital stay

时间窗: 8 months

次要结局

未报告次要终点

研究者

发起方
Max Smart
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Soofia Jamal

Department of obstetrics and gynecology

研究点 (1)

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