Comparison on Recurrence Rate of Pneumothorax Between Mesh and Apical Pleurectomy After Video-Assisted Thoracoscopic Blebectomy/Bullectomy for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial (Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Recurrence rate of pneumothorax after operation
研究概览
简要总结
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 blebectomy/bullectomy 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).
详细描述
Background/Literature 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 9.5 percent to 24.5 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 chemical8,9 and mechanical pleurodesis, fibrin glue, mesh covering, or a combination of these measures (e.g., 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 patient's 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
- Participants (Double-blinded) and Assessor (nurse who will be assigned for collecting perioperative and postoperative results after surgery)
- After obtaining informed consent and the patient's agreement to participate in the study, the patients will be allocated block sizes of four and computer-generated random numbers in sequential order within opaque envelopes that are sealed. The allocation process follows a 1:1 ratio.
- Those sealed envelopes were kept by the researcher. On the day of operation, after video-assisted thoracoscopic blebectomy/bullectomy will be done, a randomized envelope will be opened by the scrub nurse to determine which additional method would be used between partially absorbable mesh and apical pleurectomy.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (both sex) with first or second episode of primary spontaneous pneumothorax (either ipsilateral or contralateral) who have meet at least one of the following criteria for surgery below.
- •Persistent air leakage five days following the insertion of a chest tube to treat spontaneous pneumothorax3,26 or failure of lung re-expansion2
- •Air leakage after surgery will be categorized into 4 grades based on Robert David Cerfolio Classification System27; Grade1 inspire and expire air leakage (continuous air leakage), Grade 2 inspire air leakage, Grade 3 expire air leakage and Grade 4 forced expire air leakage.
- •No matter grade of air leakage, once patients have any grade of air leakage of 4-5 days after chest drain insertion, they will be diagnosed with persistent air leakage.
- •Hemopneumothorax
- •Bilateral pneumothorax
- •Visible blebs on the initial plain chest film or computed tomography
- •Professions at risk (Aircraft personals, divers)
- •Aged more than or equal to 20 years old.
排除标准
- •Hemothorax or Pneumothorax that requires bilateral thoracic surgery.
- •Previous ipsilateral thoracic operation
- •Other serious concomitant illnesses or medical conditions e.g., Congestive heart failure, unstable angina, history of myocardial infarction within 1 year prior to entering this study.
- •History of significant neurologic or psychiatric disorder
结局指标
主要结局
Recurrence rate of pneumothorax after operation
时间窗: From date of surgery until the date of last follow-up, assessed at least 12 months and up to 24 months
Recurrence rate of ipsilateral pneumothorax at least one- year follow-up period and up to 24 months after video-assisted thoracoscopic bullectomy with either partially absorbable mesh or apical pleurectomy. Gold standard for detecting recurrent pneumothorax is chest radiography and it is defined as the presence of an ipsilateral pneumothorax of any size in the follow-up chest radiography.
次要结局
- Postoperative chest tube duration (days)(From date of first postoperative day until the date of chest drain removal, assessed up to 30 days)
- Operative time (minute)(From time of skin incision until time of skin closure during intraoperative period)
- Postoperative pain (pain score)(From time of immediate postoperative period until time of the patient has been discharged or date of death from any cause, whichever came first, assessed up to 30 days)
- Composite postoperative complications(From time of immediate postoperative until time of the patient has been discharged or date of death from any cause, whichever came first, assessed up to 30 days.)
- Postoperative pleural effusion (ml)(From date of 1st postoperative day until date of chest drain removed, assessed up to 30 days)
- Hospitalization cost (baht)(From the date that patient has been admitted until the date that patient has been discharged or date of death from any cause during admitted, assessed up to 30 days)
- Intraoperative blood loss (ml)(From time of skin incision until time of skin closure during operative period)
- Dosage of morphine use after postoperative period till discharged.(From time of immediate postoperative period until time of patient discharged from hospital, assessed up to 30 days)
研究者
Apichat Tantraworasin
Associate Professor Doctor
Chiang Mai University