| CTRI Number |
CTRI/2025/09/094417 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation between Quality of Recovery after surgery and three-month Quality of Life, and Utility of the quality of recovery score questionnaire following Gynaecological Cancer Surgery |
|
Scientific Title of Study
|
Correlation between Postoperative Quality of Recovery and three-month Quality of Life, and Utility of the QoR-15 questionnaire following Gynaecological Cancer Surgery |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geetanjali T Chilkoti |
| Designation |
Professor |
| Affiliation |
UCMS and GTB hospital |
| Address |
Dept of Anesthesiology and critical care UCMS and GTB Hospital Delhi
East
DELHI
110095
India |
| Phone |
9711210772 |
| Fax |
|
| Email |
geetanjalidr@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetanjali T Chilkoti |
| Designation |
Professor |
| Affiliation |
UCMS and GTB hospital |
| Address |
Dept of Anesthesiology and critical care UCMS and GTB Hospital Delhi
DELHI
110095
India |
| Phone |
9711210772 |
| Fax |
|
| Email |
geetanjalidr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diksha Yadav |
| Designation |
PG Student |
| Affiliation |
UCMS and GTBH |
| Address |
Dept of Anesthesiology and critical care UCMS and GTB Hospital Delhi
East
DELHI
110095
India |
| Phone |
8750751852 |
| Fax |
|
| Email |
dikshayadav00007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Main ICU, Second floor, UCMS & GTB Hospital, Dilshad Garden |
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
Dept of Anesthesiology and critical care UCMS and GTB Hospital Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Diksha Yadav |
University college of medical science and GTB Hospital |
Main ICU second floor, Department of anaesthesiology and critical care, OT block, University college of medical science and GTB Hospital, Dilshad garden
East
DELHI
East
DELHI |
08750751852
dikshayadav00007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee-human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N838||Other noninflammatory disorders ofovary, fallopian tube and broad ligament, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA PS II or III undergoing cancer surgery under GA and epidural block, who can read and write Hindi and are available for three-months follow up either in person or telephonically. |
|
| ExclusionCriteria |
| Details |
Patients will be excluded if had cognitive dysfunction, alcohol or drug dependence, severe preexisting medical condition, emergency surgery or life-threatening postoperative complication. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| correlation between QoR-15H with the Quality of life using SF-12 |
correlation between QoR-15H with the Quality of life using SF-12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between various domains QoR-15H scores with the related domains of EORTC QLQ-C30; the association between QoR-15H scores with ICU stay, postoperative complications & mortality; psychometric analysis of QoR-15H in cancer surgeries. |
Correlation between various domains QoR-15H scores at day 1, 3 & 7 with the related domains of EORTC QLQ-C30 at three months; the association between QoR-15H scores with ICU stay, postoperative complications & mortality at three months; psychometric analysis of QoR-15H in cancer surgeries. |
|
|
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)
|
20/09/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
For each
patient, the Hindi version of QoR-15 i.e. QoR-15H will be filled at baseline
i.e. in the preoperative room and then again after surgery at the end of day 1,
day 3 and day 7. Higher scores indicate
a better quality of recovery. For
objective measure of postoperative global recovery, patient-perceived Global
Recovery Score (0 -no recovery; 100-Best possible recovery) and NRS-Pain (0
being no pain to 10 being worst possible pain) assessment will be recorded at the
end of postoperative day 1, 3 and 7. The primary outcome of the study is to determine correlation between QoR-15H
scores at day 1, 3 and 7 with the Quality of life using SF-12 at three months.
The secondary outcomes will be to
determine correlation between various domains QoR-15H scores at day 1, 3 and 7
with the related domains of EORTC QLQ-C30 at three months; the association between QoR-15H
scores with ICU stay, postoperative complications and mortality at three months.
In addition, the psychometric analysis of QoR-15H in gynaecological cancer
surgeries will also be done.
|