| CTRI Number |
CTRI/2025/09/094369 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find out how often women feel like throwing up and vomit after cancer related gynaecology surgeries |
|
Scientific Title of Study
|
A Prospective observational study to calculate the incidence of postoperative nausea and vomiting in patients undergoing gynecological oncology surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyadharshini |
| Designation |
Junior Resident |
| Affiliation |
Christian Medical college Vellore |
| Address |
Postgraduate Registrar
Department of Anaesthesiology
Christian medical college
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
7010895770 |
| Fax |
|
| Email |
priyaa.27s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Shirley Joselyn |
| Designation |
Professor |
| Affiliation |
Christian medical college Vellore |
| Address |
Postgraduate Registrar
Department of Anaesthesiology
Christian medical college
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
7358377164 |
| Fax |
|
| Email |
anjeyanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Shirley Joselyn |
| Designation |
Professor |
| Affiliation |
Christian medical college Vellore |
| Address |
Postgraduate Registrar
Department of Anaesthesiology
Christian medical college
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
7358377164 |
| Fax |
|
| Email |
anjeyanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian medical college
Ida Scudder Road,
Vellore – 632004
Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Priyadharshini |
| Address |
Post graduate
Department of Anaesthesia,
New Paul Brand Building 7th Floor Anaesthesia Office
CMC Vellore Town campus
Ida Scudder Road
Vellore – 632004
Tamil Nadu, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Priyadharshini |
Christian Medical College (CMC), Vellore |
Department of Anaesthesia
New Paul Brand Building (7th Floor Anaesthesia Office)
CMC Vellore Town Campus
Ida Scudder Road
Vellore – 632004
Tamil Nadu,
Vellore
TAMIL NADU |
7010895770
priyaa.27s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Review Board (Ethics and Research Committee) of the Christian Medical College V |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Elective Gyne oncology surgery patients of ASA I, II |
|
| ExclusionCriteria |
| Details |
1. Refusal of consent,
2. Patients with pre-existing nausea or vomiting within 24 hours before surgery
3. Patients on chronic antiemetic therapy or medications known to affect nausea and vomiting
4. Patient requiring postop ventilation,on ionotropes,admitted to ICU. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To calculate the incidence of postoperative nausea and vomiting in gynae- oncology surgery patients till their time of discharge |
4 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To calculate the incidence of PONV between laparoscopic & open surgeries in gyne oncology.
To correlate the incidence of PONV with preoperative demographic features & intraoperative anesthesia management.
To calculate the risk factors for PONV in perioperative period. |
4 days |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
22/09/2025 |
| 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="0"
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
|
This prospective observational study aims to evaluate the incidence of postoperative nausea and vomiting in patients undergoing gynecological oncology surgeries under anesthesia. It also seeks to identify perioperative factors associated with the occurrence of PONV. Patients scheduled for elective gynecological oncology procedures will be followed until discharge. Anesthetic and analgesic management will be at the discretion of the attending anesthesiologist in the operating room. The severity of PONV will be assessed using a standardized grading scale. Data collected will include demographic variables, intraoperative medications (anesthetics, analgesics, muscle relaxants, antiemetics), hemodynamic parameters, and fluid and blood product administration. The study will analyze the overall incidence and contributing risk factors for PONV during the perioperative period. |