Predictors Of Post-Operative Morbidity and Mortality After Debulking Surgeries For Gynaecological Malignancies.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Preoperative operative status
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients with carcinoma of vagina or vulva posted for surgery.
- •Palliative surgeries and stoma formation.
Outcomes
Primary Outcomes
Preoperative operative status
Time Frame: Morbidity at 30 days and 90 days
Tumor status
Time Frame: Morbidity at 30 days and 90 days
Intraoperative surgical parameters
Time Frame: Morbidity at 30 days and 90 days
Post-operative complications
Time Frame: Morbidity at 30 days and 90 days
30-day major morbidity
Time Frame: Morbidity at 30 days and 90 days
Secondary Outcomes
- 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)
Investigators
SAURABH VIG
NCI, All Institute of Medical Sciences