| CTRI Number |
CTRI/2024/05/067421 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predictors of mortality and morbidity after debulking surgeries for gynaecological malignancies. |
|
Scientific Title of Study
|
Predictors Of Post-Operative Morbidity and Mortality After Debulking Surgeries For Gynaecological Malignancies. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAURABH VIG |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NCI, All Institute of Medical Sciences |
| Address |
ROOM 116, ACADEMIC BLOCK, NCI, All Institute of Medical Sciences
N/A
Jhajjar
HARYANA
124105
India |
| Phone |
9538247725 |
| Fax |
|
| Email |
saurabh377@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SAURABH VIG |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NCI, All India Institute of Medical Sciences |
| Address |
ROOM 116, ACADEMIC BLOCK, NCI, All India Institute of Medical Sciences, New Delhi
N/A
Jhajjar
HARYANA
124105
India |
| Phone |
9538247725 |
| Fax |
|
| Email |
saurabh377@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SAURABH VIG |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NCI, All India Institute of Medical Science, New Delhi |
| Address |
ROOM 116, ACADEMIC BLOCK, NCI, All India Institute of Medical Science, New Delhi
N/A
Jhajjar
HARYANA
124105
India |
| Phone |
9538247725 |
| Fax |
|
| Email |
saurabh377@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia , National Cancer Institute, Jhajjar,All India Institute Of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SAURABH VIG |
NATIONAL CANCER INSTITUTE |
Room No 2, Academic Block, National Cancer Institute, All India Institute of Medical Science
Sciences.
Jhajjar
HARYANA |
9538247725
saurabh377@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE. ALL INDIA INSTITUTE OF MEDICAL SCIENCES.ROOM NO. 102.1ST FLOOR OLD OT BLOCK.ANSARI NAGAR,NEW DELHI 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N879||Dysplasia of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with ovarian/fallopian tube/primary peritoneal cancer posted for primary or interval cytoreductive surgery.
2. Patients with endometrial cancer or cervical cancer posted for radical hysterectomy.
3. Patients with undiagnosed adnexal masses posted for laparotomy, frozen section, and staging surgery.
|
|
| ExclusionCriteria |
| Details |
1. Patients with carcinoma of vagina or vulva posted for surgery.
2. Palliative surgeries and stoma formation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Preoperative operative status
Tumor status
Intraoperative surgical parameters
Post-operative complications
30-day major morbidity |
Morbidity at 30 days and 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [saurabh377@yahoo.com].
- For how long will this data be available start date provided 01-08-2026 and end date provided 01-08-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
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. |