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临床试验/CTRI/2024/05/067421
CTRI/2024/05/067421尚未招募不适用

Predictors Of Post-Operative Morbidity and Mortality After Debulking Surgeries For Gynaecological Malignancies.

ALL INDIA INSTITUTE OF MEDICAL SCIENCES1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Preoperative operative status

研究概览

简要总结

Indian population affected by gynaecological malignancies differs from western population in various aspects. The body habitus, preoperative nutritional status, comorbidity optimization, stage at presentation, follow up and adherence to the planned management protocol etc. may differ from the western population. Thus, the factors affecting surgical outcomes and further treatment plan after gynaecological cancer surgeries in the Indian population may be different from the current available data. This study aims to study predictors of post operative morbidity and mortality after gynaecological cancer resection in the Indian patient population.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
Female

入选标准

  • Patients with ovarian/fallopian tube/primary peritoneal cancer posted for primary or interval cytoreductive surgery.
  • Patients with endometrial cancer or cervical cancer posted for radical hysterectomy.
  • Patients with undiagnosed adnexal masses posted for laparotomy, frozen section, and staging surgery.

排除标准

  • Patients with carcinoma of vagina or vulva posted for surgery.
  • Palliative surgeries and stoma formation.

结局指标

主要结局

Preoperative operative status

时间窗: Morbidity at 30 days and 90 days

Tumor status

时间窗: Morbidity at 30 days and 90 days

Intraoperative surgical parameters

时间窗: Morbidity at 30 days and 90 days

Post-operative complications

时间窗: Morbidity at 30 days and 90 days

30-day major morbidity

时间窗: Morbidity at 30 days and 90 days

次要结局

  • Factors associated with 90-day mortality in patients undergoing debulking surgeries for gynecological malignancies(90 DAYS AFTER SURGERY)
  • Factors associated with delay (beyond 42 days) in the start of adjuvant oncological therapy in patients undergoing debulking surgeries for gynecological malignancies(42 DAYS AFTER SURGERY)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

SAURABH VIG

NCI, All Institute of Medical Sciences

研究点 (1)

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