Patient reported and functional outcomes in patients undergoing surgery for pulmonary aspergilloma.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Vishethi Singh Sisodia
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- 1. Symptomatic Improvement.
Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All patients operated for pulmonary aspergilloma age between 18-65 years.
- •In retrospective arm.
- •patients from January 2014 till time of obtaining ethical clerance.
- •In prospective arm.
- •patients from time of ethical clearance till July 2026.
Exclusion Criteria
- •Patient lost to follow up.
Outcomes
Primary Outcomes
1. Symptomatic Improvement.
Time Frame: at baseline, | at 1st week | at 4th week | at 12th week.
2. Change in pulmonary function test.
Time Frame: at baseline, | at 1st week | at 4th week | at 12th week.
Secondary Outcomes
- 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)
Investigators
Dr Vishethi Singh Sisodia
AIIMS, New Delhi