Clinical trial NCT06452680: The Effect of Preserving Inferior Pulmonary Ligamen on Symptom Burden in Thoracoscopic Pneumonectomy
Official title: The Effect of Preserving Inferior Pulmonary Ligamen on Symptom Burden and Clinical Outcomes in Thoracoscopic Pneumonectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Surgical Procedures
Patient Reported Outcome Measures
Keywords: Inferior pulmonary ligment
Pulmonary Surgical Procedures
Patient Reported Outcome Measures
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Dissection of the inferior pulmonary ligament (IPL) has been a common practice in upper lobectomy to facilitate the expansion of the remaining lung, reduce dead space after resection, and minimize complications such as pleural effusion and pulmonary infection. However, studies have found that IPL dissection does not improve patient outcomes. On the contrary, releasing the restriction may lead to excessive movement of the remaining lobes, resulting in significant changes in bronchial angles and lung volume, which can worsen pulmonary function and increase postoperative symptoms. Most existing studies are retrospective, providing relatively low-level evidence. Moreover, previous research has primarily focused on radiographic outcomes and pulmonary function tests results, while the effect on patients' symptom burden has been largely overlooked. From the patient's perspective, symptom burden might be more significant, reflecting the clinical value of changes in radiographic and functional indices. In this study, the investigators applied patient-reported outcomes to measure symptoms. Combined with pulmonary function results and radiological outcomes, the investigators compared the clinical value of preserving versus dissecting the IPL in upper lobectomy.

Eligibility criteria: Inclusion Criteria:

1. Patients underwent upper lobe resection
2. Patients could complete our questionnaires

Exclusion Criteria:

1. Previous history of ipsilateral lung surgery
2. Patients who underwent pleurodesis

Primary outcomes:
measure: Cough score postoperation
timeFrame: up to 3 months
Secondary outcomes:
measure: Other Symptom burden postoperation PSA-LUNG questionnaire
timeFrame: up to 3 months
measure: Radiological outcome
timeFrame: Day 1 after surgery; 1 month after discharge; 3 months after discharge
measure: Radiological outcome
timeFrame: Day 1 after surgery; 1 month after discharge; 3 months after discharge
measure: Radiological outcome
timeFrame: Day 1 after surgery; 1 month after discharge; 3 months after discharge
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: General Hospital of Southern Theater Command of the Chinese People's Liberation Army
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Affiliated Panyu Central Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangdong Pharmaceutical University
state: Guangdong
city: Shantou
country: China
facility: Shantou University Medical College
state: Guangdong
Study officials:
affiliation: Guangdong Province People's Hospital
name: Guibin Qiao, MD
role: STUDY_CHAIR
References: