The Effect of Preserving Inferior Pulmonary Ligamen on Symptom Burden in Thoracoscopic Pneumonectomy

Patient Reported Outcome Measures Clinical Trial

— PRO-IPL  

Official title:

The Effect of Preserving Inferior Pulmonary Ligamen on Symptom Burden and Clinical Outcomes in Thoracoscopic Pneumonectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452680
• Other study ID #: KY2023-804-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: August 2024

Study information

• Verified date: June 2024
• Source: Guangdong Provincial People's Hospital
• Contact: Guibin Qiao, MD
• Phone: 13602749153
• Email: guibinqiao[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators conducted a muti-centres randomized controlled clinical trial to explore the effect of preservation of inferior pulmonary ligment compared with dissection.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Reported Outcome Measures
• Pulmonary Surgical Procedures

Intervention

Procedure:
• Preserving IPL during surgery
IPL was preserved during surgery

Locations

Country	Name	City	State
China	General Hospital of Southern Theater Command of the Chinese People's Liberation Army	Guangzhou	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The Affiliated Panyu Central Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangdong Pharmaceutical University	Guangzhou	Guangdong
China	Shantou University Medical College	Shantou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Other Symptom burden postoperation PSA-LUNG questionnaire	Using PSA-LUNG questionnaire, the investigators assessed shortness of breath, pain, sleeplessness, annoy, and fatigue after surgery.	up to 3 months
Secondary	Radiological outcome	Changing of bronchial angels measured with chest x-ray examination or chest CT.	Day 1 after surgery; 1 month after discharge; 3 months after discharge
Secondary	Radiological outcome	dead spece rate measured with chest x-ray examination or chest CT.	Day 1 after surgery; 1 month after discharge; 3 months after discharge
Secondary	Radiological outcome	degree of lung collapse measured with chest x-ray examination or chest CT.	Day 1 after surgery; 1 month after discharge; 3 months after discharge