Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413966
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-03-21
Brief Title:
Study Compares Pneumothorax Recurrence Absorbable Mesh vs Pleurectomy in Primary Spontaneous Pneumothorax
Sponsor:
Chiang Mai University
Organization:
Chiang Mai University
Study Overview
Official Title:
Comparison on Recurrence Rate of Pneumothorax Between Mesh and Apical Pleurectomy After Video-Assisted Thoracoscopic BlebectomyBullectomy for Primary Spontaneous Pneumothorax A Randomized Controlled Trial Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This is a prospective randomized controlled trial pilot study that aims to determine the incidence of post-operative recurrent pneumothorax within one-year timeframe after video-assisted thoracoscopic blebectomybullectomy with either apical pleurectomy or partially absorbable mesh as well as to assess the efficacy in preventing post-operative recurrence pneumothorax Patients aged more than or equal 20-year-old with the diagnosis of primary spontaneous pneumothorax who require video-assisted thoracoscopic surgery at Maharaj Nakorn Chiangmai Hospital Chiang Mai University Chiang Mai Thailand will be enrolled into this study The inform consent will be obtained before the enrollment Patients will be randomized to two groups Partially absorbable mesh coverage group intervention group and Apical pleurectomy group control group
Detailed Description:
BackgroundLiterature Review
Primary spontaneous pneumothorax PSP is one of the most common respiratory conditions that usually occurs in young patients While not a serious illness it is worrisome because of its high rate of recurrence ranging from 17 to 54 Initial management for PSP is pleural drainage by aspiration of chest tube thoracostomy Surgical intervention is needed if there was persistent air leakage more than or equal to 5 days after chest tube insertion or recurrent pneumothorax
According to the British Thoracic Surgery BTS guideline for spontaneous pneumothorax both open thoracotomy and video-assisted thoracotomy to blebectomy with apical pleurectomy is comparable in treating difficult or recurrent pneumothorax and considered a mainstay of treatment Video-assisted thoracoscopic surgery VAT is a preferred surgical method for treating recurrence PSP because of its minimal invasiveness and low morbidity which includes shorter length of hospital stays less post-operative pain and post-operative pulmonary dysfunction However the frequency of post-operative recurrent pneumothorax following VAT procedure is higher than that of a conventional open thoracotomy with reports of less than 1 percent This frequency for that of VAT ranges from 95 percent to 245 percent Therefore when employing a less invasive approach this needs to be balanced against the slight increase in recurrence rate
The possible risk factors for recurrent pneumothorax after VAT include staple line leakage overlooked or concealed blebs bullae degeneration incomplete resection of blebs emphysematous changes in the resected area and visceral pleura damage during procedures6 To minimize postoperative recurrence other preventive measures were introduced in addition to apical pleurectomy such as chemical89 and mechanical pleurodesis fibrin glue mesh covering or a combination of these measures eg fibrin glue with mesh coverage However aside from apical pleurectomy which have been mentioned in the BTS guideline there is currently no other conclusive additional procedure that has been considered as part of standard treatment necessitating further research
Chemical pleurodesis yields an excellent rate of success in minimizing postoperative recurrent pneumothorax It is simple and considered a cost-effective method However complete pleural symphysis can impair a patients pulmonary function and sometimes produce chronic chest pain Pleurectomy also increases the risk of postoperative bleeding resulting in a longer period of chest tube insertion and fibrothorax which could be challenging for future thoracic surgery
Apical pleurectomy is one of the most widely used procedures because of its safety and feasibility It results in adhesion between the visceral and parietal pleura preventing the recurrence of postoperative pneumothorax According to systemic review mechanical apical pleurectomy exhibits comparable results in terms of 1-year postoperative recurrence pneumothorax as apical pleurectomy after thoracoscopic stapled blebectomybullectomy p-value of 0821 However it produces less residual chest pain and a lower rate of hemothorax than apical pleurectomy
Mesh coverage is increasing in popularity due to its reduction in postoperative recurrent pneumothorax postoperative bleeding and postoperative pain16 comparing to other additive procedure including apical pleurectomy Despite of the fact that both apical pleurectomy and mesh coverage have a comparable result in preventing post-operative recurrent pneumothorax patients who underwent mechanical apical pleurectomy experienced with more severe residual pain than those with mesh coverage Previous study found that the use of absorbable mesh for staple line coverage after blebectomybullectomy can significantly decrease postoperative pneumothorax with a recurrence rate of 26 compared with 95 in patients who received VATS after blebectomybullectomy alone The previous studies also display similar surgical outcomes
Additional mechanical pleurodesis after covering the staple line with absorbable cellulose mesh and fibrin glue can also significantly lower the recurrent rate of postoperative pneumothorax with a recurrence rate of 40
The postoperative 1-year recurrence rate was 95 in the absorbable mesh with fibrin glue group and 107 in the mechanical pleurodesis group
As demonstrated in the preceding paragraphs mesh coverage with or without additional techniques such as fibrin glue has been utilized in numerous prospective and retrospective studies to reinforce visceral pleura and symphyseal effects in order to prevent post-operative recurrent pneumothorax However due to its limited application in Thai clinical practice information regarding the effectiveness of this surgical technique in preventing post-operative recurrent pneumothorax is scarce Therefore our goal is to conduct a prospective randomized controlled trial pilot study to determine whether the use of mesh as an additional procedure is more effective than the conventional technique which is apical pleurectomy in terms of preventing post-operative recurrent pneumothorax in patients with PSP who underwent video-assisted thoracoscopic blebectomybullectomy
Rationale
In standard of care for patients diagnosed with PSP who met the criteria for surgical treatment at Maharaj Nakorn Chiangmai Hospital blebectomy or bullectomy with apical pleurectomy under video-assisted thoracoscopic approach will be performed The utilization of mesh coverage as a preventive measure remains uncommon in Maharaj Nakorn Chiangmai Hospital as well as in the majority of hospitals throughout Thailand This stands in contrast to Japan Korea or Taiwan where the use of mesh coverage to prevent post-operative pneumothorax has produced favorable results As a result compared to the standard of care which is apical pleurectomy there are still not many studies done in Thailand to assess the efficacy of mesh in preventing postoperative pneumothorax Therefore the researcher is motivated to carry out this study in order to assess the efficacy of mesh As of yet the mesh remains incapable of distributing funds in accordance with the patients healthcare coverage As a result funding requests are required to carry out this research investigation Should the results prove to be significant it could subsequently be implemented as an alternative or even become a standard treatment for patients with PSP who were surgical candidates at Maharaj Nakorn Chiangmai hospital Furthermore funds for this treatment which includes the cost of the mesh could possibly be deducted from the patients healthcare coverage
Objectives
Determine the incidence of post-operative recurrent pneumothorax within one-year timeframe after video-assisted thoracoscopic blebectomybullectomy with either apical pleurectomy or partially absorbable mesh
Assess the efficacy in preventing post-operative recurrence pneumothorax after video-assisted thoracoscopic blebectomybullectomy with either apical pleurectomy or partially absorbable mesh
To compare the peri-operative and post-operative outcomes as well as post-operative complications of these two surgical techniques
Primary spontaneous pneumothorax PSP is one of the most common respiratory conditions that usually occurs in young patients While not a serious illness it is worrisome because of its high rate of recurrence ranging from 17 to 54 Initial management for PSP is pleural drainage by aspiration of chest tube thoracostomy Surgical intervention is needed if there was persistent air leakage more than or equal to 5 days after chest tube insertion or recurrent pneumothorax
According to the British Thoracic Surgery BTS guideline for spontaneous pneumothorax both open thoracotomy and video-assisted thoracotomy to blebectomy with apical pleurectomy is comparable in treating difficult or recurrent pneumothorax and considered a mainstay of treatment Video-assisted thoracoscopic surgery VAT is a preferred surgical method for treating recurrence PSP because of its minimal invasiveness and low morbidity which includes shorter length of hospital stays less post-operative pain and post-operative pulmonary dysfunction However the frequency of post-operative recurrent pneumothorax following VAT procedure is higher than that of a conventional open thoracotomy with reports of less than 1 percent This frequency for that of VAT ranges from 95 percent to 245 percent Therefore when employing a less invasive approach this needs to be balanced against the slight increase in recurrence rate
The possible risk factors for recurrent pneumothorax after VAT include staple line leakage overlooked or concealed blebs bullae degeneration incomplete resection of blebs emphysematous changes in the resected area and visceral pleura damage during procedures6 To minimize postoperative recurrence other preventive measures were introduced in addition to apical pleurectomy such as chemical89 and mechanical pleurodesis fibrin glue mesh covering or a combination of these measures eg fibrin glue with mesh coverage However aside from apical pleurectomy which have been mentioned in the BTS guideline there is currently no other conclusive additional procedure that has been considered as part of standard treatment necessitating further research
Chemical pleurodesis yields an excellent rate of success in minimizing postoperative recurrent pneumothorax It is simple and considered a cost-effective method However complete pleural symphysis can impair a patients pulmonary function and sometimes produce chronic chest pain Pleurectomy also increases the risk of postoperative bleeding resulting in a longer period of chest tube insertion and fibrothorax which could be challenging for future thoracic surgery
Apical pleurectomy is one of the most widely used procedures because of its safety and feasibility It results in adhesion between the visceral and parietal pleura preventing the recurrence of postoperative pneumothorax According to systemic review mechanical apical pleurectomy exhibits comparable results in terms of 1-year postoperative recurrence pneumothorax as apical pleurectomy after thoracoscopic stapled blebectomybullectomy p-value of 0821 However it produces less residual chest pain and a lower rate of hemothorax than apical pleurectomy
Mesh coverage is increasing in popularity due to its reduction in postoperative recurrent pneumothorax postoperative bleeding and postoperative pain16 comparing to other additive procedure including apical pleurectomy Despite of the fact that both apical pleurectomy and mesh coverage have a comparable result in preventing post-operative recurrent pneumothorax patients who underwent mechanical apical pleurectomy experienced with more severe residual pain than those with mesh coverage Previous study found that the use of absorbable mesh for staple line coverage after blebectomybullectomy can significantly decrease postoperative pneumothorax with a recurrence rate of 26 compared with 95 in patients who received VATS after blebectomybullectomy alone The previous studies also display similar surgical outcomes
Additional mechanical pleurodesis after covering the staple line with absorbable cellulose mesh and fibrin glue can also significantly lower the recurrent rate of postoperative pneumothorax with a recurrence rate of 40
The postoperative 1-year recurrence rate was 95 in the absorbable mesh with fibrin glue group and 107 in the mechanical pleurodesis group
As demonstrated in the preceding paragraphs mesh coverage with or without additional techniques such as fibrin glue has been utilized in numerous prospective and retrospective studies to reinforce visceral pleura and symphyseal effects in order to prevent post-operative recurrent pneumothorax However due to its limited application in Thai clinical practice information regarding the effectiveness of this surgical technique in preventing post-operative recurrent pneumothorax is scarce Therefore our goal is to conduct a prospective randomized controlled trial pilot study to determine whether the use of mesh as an additional procedure is more effective than the conventional technique which is apical pleurectomy in terms of preventing post-operative recurrent pneumothorax in patients with PSP who underwent video-assisted thoracoscopic blebectomybullectomy
Rationale
In standard of care for patients diagnosed with PSP who met the criteria for surgical treatment at Maharaj Nakorn Chiangmai Hospital blebectomy or bullectomy with apical pleurectomy under video-assisted thoracoscopic approach will be performed The utilization of mesh coverage as a preventive measure remains uncommon in Maharaj Nakorn Chiangmai Hospital as well as in the majority of hospitals throughout Thailand This stands in contrast to Japan Korea or Taiwan where the use of mesh coverage to prevent post-operative pneumothorax has produced favorable results As a result compared to the standard of care which is apical pleurectomy there are still not many studies done in Thailand to assess the efficacy of mesh in preventing postoperative pneumothorax Therefore the researcher is motivated to carry out this study in order to assess the efficacy of mesh As of yet the mesh remains incapable of distributing funds in accordance with the patients healthcare coverage As a result funding requests are required to carry out this research investigation Should the results prove to be significant it could subsequently be implemented as an alternative or even become a standard treatment for patients with PSP who were surgical candidates at Maharaj Nakorn Chiangmai hospital Furthermore funds for this treatment which includes the cost of the mesh could possibly be deducted from the patients healthcare coverage
Objectives
Determine the incidence of post-operative recurrent pneumothorax within one-year timeframe after video-assisted thoracoscopic blebectomybullectomy with either apical pleurectomy or partially absorbable mesh
Assess the efficacy in preventing post-operative recurrence pneumothorax after video-assisted thoracoscopic blebectomybullectomy with either apical pleurectomy or partially absorbable mesh
To compare the peri-operative and post-operative outcomes as well as post-operative complications of these two surgical techniques
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