| CTRI Number |
CTRI/2025/08/092793 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
10/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Follow up study of patients after lung surgery for pulmonary aspergilloma. |
|
Scientific Title of Study
|
Patient reported and functional outcomes in patients undergoing surgery for pulmonary aspergilloma. |
| 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 Vishethi Singh Sisodia |
| Designation |
Junior Resident, Department of Surgical Disciplines |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no. 204
Surgery block, AIIMS
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8319324273 |
| Fax |
|
| Email |
vishethisisodia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeet Kumar Rai |
| Designation |
Assistant Professor, Department of Surgical Disciplines |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no. 426,
Surgery block,AIIMS
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9958613771 |
| Fax |
|
| Email |
drsanju1678@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishethi Singh Sisodia |
| Designation |
Junior Resident, Department of Surgical Disciplines |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no. 204
Surgery block, AIIMS
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8319324273 |
| Fax |
|
| Email |
vishethisisodia@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Ansari Nagar, New Delhi ,110029 India
|
|
|
Primary Sponsor
|
| Name |
Dr Vishethi Singh Sisodia |
| Address |
Room no. 204
Surgery Block, AIIMS
Ansari Nagar, New Delhi ,110029
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 Vishethi Singh Sisodia |
AIIMS New Delhi |
Room no. 1, ground floor-OPD
Department of surgical disciplines
Surgery Block, AIIMS New Delhi
South
DELHI |
8319324273
vishethisisodia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES,ANSARI NAGAR ,NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B441||Other pulmonary aspergillosis, (2) ICD-10 Condition: B440||Invasive pulmonary aspergillosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients operated for pulmonary aspergilloma age between 18-65 years.
2. In retrospective arm - patients from January 2014 till time of obtaining ethical clerance.
3. In prospective arm - patients from time of ethical clearance till July 2026. |
|
| ExclusionCriteria |
| Details |
1. Patient lost to follow up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Symptomatic Improvement.
2. Change in pulmonary function test.
|
at baseline,
at 1st week
at 4th week
at 12th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence of symptoms |
July 2026 |
| Factors leading to recurrence |
July 2026 |
| Incidence of chronic chest pain |
3 months post surgery |
| Incidence of ipsilateral shoulder pain |
3 months post surgery |
| Limitation of ipsilateral shoulder joint movement |
3 months post surgery |
| To corelate features suggesting difficult surgery with post operative recovery and complications |
July 2026 |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
21/08/2025 |
| 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 will be an observational study with both retrospective and prospective arm. The study will be conducted in surgery unit 3 in department of surgical disciplines, AIIMS New Delhi. Patients of age 18-65 years and both gender who have undergone surgery for pulmonary aspergilloma will be included. The retrospective arm will include patients from January 2014 till the time of obtaining ethical clearance. The prospective arm will include patients operated for pulmonary aspergilloma from the time of ethical clearance till July 2026. Written informed consent will be obtained from the participants of the prospective arm for inclusion in study. The medical case record files of the patients in the retrospective arm will be retrieved from medical record sections for collection of data. Parameters like demographic details, history of smoking, pre-existing pulmonary disease, comorbidities, pulmonary disease in family, symptoms, treatment prior to surgery, haematological investigations, radiological investigations, pulmonary function test, type of surgery, parameter of difficult surgery, post operative pain, post operative complications, ipsilateral shoulder joint mobility, ipsilateral shoulder joint pain, recurrence of disease, relief of symptoms will be recorded. Based on review of literature it is expected that approximately 85 percent of cases will be presenting symptomatically warranting surgery. Therefore, assuming this as the anticipated proportion, a minimum of 35 cases will be required in prospective study. Earnest attempts will be made to recruit these minimum number of cases, however in case it limits due logistical or feasible aspects, data collected from available cases will be analysed and reported. |