Viewing Study NCT06452680



Ignite Creation Date: 2024-06-16 @ 11:51 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06452680
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-11
First Post: 2024-05-30

Brief Title: The Effect of Preserving Inferior Pulmonary Ligamen on Symptom Burden in Thoracoscopic Pneumonectomy
Sponsor: Guangdong Provincial Peoples Hospital
Organization: Guangdong Provincial Peoples Hospital

Study Overview

Official Title: The Effect of Preserving Inferior Pulmonary Ligamen on Symptom Burden and Clinical Outcomes in Thoracoscopic Pneumonectomy
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PRO-IPL
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 patients 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None