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

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Surgical Procedures; Patient Reported Outcome Measures
• Interventions: Procedure: Preserving IPL during surgery

• Registration Number: NCT06452680
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Study First Submitted: 2024-05-30
• Status Verified: 2024-06
• Study Start: 2024-06
• Primary Completion: 2024-06
• Study First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preservation group	Preserving IPL during surgery	In the preservation group, the IPL was untouched

Primary Outcome Measures

Name	Time	Method
Cough score postoperation	up to 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Radiological outcome	Day 1 after surgery; 1 month after discharge; 3 months after discharge	degree of lung collapse measured with chest x-ray examination or chest CT.
Other Symptom burden postoperation PSA-LUNG questionnaire	up to 3 months	Using PSA-LUNG questionnaire, the investigators assessed shortness of breath, pain, sleeplessness, annoy, and fatigue after surgery.

Trial Locations

Locations (5)

The Affiliated Panyu Central Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Shantou University Medical College; 🇨🇳 Shantou, Guangdong, China

The First Affiliated Hospital of Guangdong Pharmaceutical University; 🇨🇳 Guangzhou, Guangdong, 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