The Effect of Preserving Inferior Pulmonary Ligamen on Symptom Burden in Thoracoscopic Pneumonectomy
PRO-IPL
1 other identifier
interventional
200
1 country
5
Brief Summary
The investigators conducted a muti-centres randomized controlled clinical trial to explore the effect of preservation of inferior pulmonary ligment compared with dissection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedFirst Posted
Study publicly available on registry
June 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedJune 11, 2024
June 1, 2024
Same day
May 30, 2024
June 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cough score postoperation
The investigators used PSA-LUNG questionnaire to assess patients symptom burden after surgery. Changing of cough score during 1 month postoperation was chosen as the primary outcome.
up to 3 months
Secondary Outcomes (4)
Other Symptom burden postoperation PSA-LUNG questionnaire
up to 3 months
Radiological outcome
Day 1 after surgery; 1 month after discharge; 3 months after discharge
Radiological outcome
Day 1 after surgery; 1 month after discharge; 3 months after discharge
Radiological outcome
Day 1 after surgery; 1 month after discharge; 3 months after discharge
Study Arms (2)
Preservation group
EXPERIMENTALIn the preservation group, the IPL was untouched
Dissection group
NO INTERVENTIONIn the dissection group, the IPL was commonly dissected until the inferior pulmonary vein was exposed
Interventions
Eligibility Criteria
You may qualify if:
- Patients underwent upper lobe resection
- Patients could complete our questionnaires
You may not qualify if:
- Previous history of ipsilateral lung surgery
- Patients who underwent pleurodesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
General Hospital of Southern Theater Command of the Chinese People's Liberation Army
Guangzhou, Guangdong, 510080, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510080, China
Shantou University Medical College
Shantou, Guangdong, 515041, China
Study Officials
- STUDY CHAIR
Guibin Qiao, MD
Guangdong Province People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
May 30, 2024
First Posted
June 11, 2024
Study Start
June 1, 2024
Primary Completion
June 1, 2024
Study Completion
August 1, 2024
Last Updated
June 11, 2024
Record last verified: 2024-06