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

NCT ID: NCT06452680

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2024-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pulmonary Surgical Procedures Patient Reported Outcome Measures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Preservation group

In the preservation group, the IPL was untouched

Group Type EXPERIMENTAL

Preserving IPL during surgery

Intervention Type PROCEDURE

IPL was preserved during surgery

Dissection group

In the dissection group, the IPL was commonly dissected until the inferior pulmonary vein was exposed

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preserving IPL during surgery

IPL was preserved during surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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GuiBin Qiao

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guibin Qiao, MD

Role: STUDY_CHAIR

Guangdong Province People's Hospital

Locations

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General Hospital of Southern Theater Command of the Chinese People's Liberation Army

Guangzhou, Guangdong, China

Site Status

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status

The Affiliated Panyu Central Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Site Status

Shantou University Medical College

Shantou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Guibin Qiao, MD

Role: CONTACT

[email protected]
13602749153

Facility Contacts

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Xianglin Li

Role: primary

[email protected]

Guibin Qiao

Role: primary

[email protected]
13602749153

Xianglin Li

Role: backup

[email protected]
18550570726

Xianglin Li

Role: primary

[email protected]

Xianglin Li

Role: primary

[email protected]

Xianglin Li

Role: primary

[email protected]

Other Identifiers

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KY2023-804-02

Identifier Type: -

Identifier Source: org_study_id

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