| CTRI Number |
CTRI/2026/01/101894 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of risk factors leading to postoperative pulmonary complications after surgeries for gynecological cancer |
|
Scientific Title of Study
|
Occurrence of postoperative pulmonary complications and risk factors associated with it after surgeries for gynecological malignancy: A single-centre prospective observational study. |
| 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 Anuradha Patel |
| Designation |
Assistant Professor |
| Affiliation |
Delhi State Cancer Institute |
| Address |
Room number 8, Department of Oncoanaesthesia, Delhi State Cancer Institute, East Delhi
East
DELHI
110095
India |
| Phone |
9205772036 |
| Fax |
|
| Email |
patelanuradha20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Patel |
| Designation |
Assistant Professor |
| Affiliation |
Delhi State Cancer Institute |
| Address |
Room number 8, Department of Oncoanaesthesia, Delhi State Cancer Institute, East Delhi
East
DELHI
110095
India |
| Phone |
9205772036 |
| Fax |
|
| Email |
patelanuradha20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Patel |
| Designation |
Assistant Professor |
| Affiliation |
Delhi State Cancer Institute |
| Address |
Room number 8, Department of Oncoanaesthesia, Delhi State Cancer Institute, East Delhi
East
DELHI
110095
India |
| Phone |
9205772036 |
| Fax |
|
| Email |
patelanuradha20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Delhi State Cancer Institute, Delhi, India, 110095 |
|
|
Primary Sponsor
|
| Name |
Delhi State Cancer Institute |
| Address |
Delhi State Cancer Institute, Dilshad Garden, Delhi, India-110095 |
| Type of Sponsor |
Other [Delhi State Cancer Institute (Government 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 Anuradha Patel |
DElhi State Cancer Institute |
Room number 8, Department of Oncoanaesthesia, Delhi State Cancer Institute, East Delhi, 110095
East
DELHI |
9205772036
patelanuradha20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Delhi State Cancer Institute Institutional Ethics Committee |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
ASA I-III with histologically confirmed malignancy or a high suspicion of a gynecologic malignancy arising from imaging or laboratory results and undergoing elective laparotomy with an expected duration of minimum 1 hour will be eligible for the study. |
|
| ExclusionCriteria |
| Details |
Patients preoperatively on ventilator, and patients with preoperative pulmonary complica-tions will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the occurrence of postoperative pulmonary complications (incidence) in patients undergoing surgeries for gynecological malignancy |
Patients will be assessed on postoperative Day 1, Day 2 and Day 3 till 72 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the association between occurrence of postoperative pulmonary complications and associated risk factors. |
72 hours |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
10/02/2026 |
| 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="2"
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
|
Postoperative pulmonary complications may delay patients in receiving adjuvant treatment that may impact treatment outcomes. Hence, analysis of risk factors associated with POPC is important and thus measures can be taken preoperatively to modify these risk factors. This observational prospective study is designed to see the occurrence and risk factors for postoperative pulmonary complications after surgeries for gynecological malignancy. This study will evaluate the association between occurence of postoperative pulmonary complications and associated risk factors. We will follow the patients for 72 hours postoperatively to assess for postoperative complications. |