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Video-assisted thoracoscopic surgery versus traditional thoracotomy for decortication of stage III tuberculous empyema: a randomized controlled clinical trial

Video-assisted thoracoscopic surgery versus traditional thoracotomy for decortication of stage III tuberculous empyema: a randomized controlled clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045792
Enrollment
Unknown
Registered
2021-04-25
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculous Empyema( stage III )

Interventions

experimental group:Video-assisted Thoracoscopic Surgery
control group:Traditional Thoracotomy

Sponsors

The Public Health Clinical Center of Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Any preoperative work-ups based on the etiology confirmed tuberculosis(TB), i.e. smear of sputum or other secretions, and bronchial brushing examination.Or only clinically diagnosed as tuberculosis; 2.Age ranging from 18 to 75 years old; 3.Rate of ventilation function over or equal 40%; 4.Lesions of TB on ipsilateral side stable; 5.Lesions on contralateral side also stable,e.g.calcified ones on CT scan; 6.Smear of sputum negative or positive about TB; 7.Cases who are tolerant of general anesthesia; 8.Anti-TB chemical treatment achieved at least 2-3 weeks; 9.Encysted empyema presents on chest CT scan preoperatively, which formed a clear boundary from the adjacent pulmonary issues and the pleura surrounding the empyema thicken, namely the parietal and visceral pleura; 10.The results of surgery anticipated quite well, in other words, undergoing the operation of decortication and the repairment of bronchial?fistula; 11.The medical records obtained without missing; 12.Patients involved voluntary to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.Cases with empyema all over the whole chest inside on chest CT scan; 2.Cases both with empyema and tuberculosis on chest wall or pulmonary tissues which need to be underwent surgical resection; 3.Severe malformations of chest wall, namely intercostal spaces disappear and ribs involved are imbricated on chest CT scan; 4.Cases with adjacent mediastinal pleura thicken; 5.Cases undergoing glucocorticoid hormone treatment preoperatively; 6.Cases with severe mental disorders; 7.Cases with contraindications, e.g. cardiac infarction within 30 days, severe arrhythmia, coagulation disorders, blood glucose and/or blood pressure not controlled well, cardiac insufficiency(Grade III-IV), moderate-severe COPD, asthma not controlled well, and moderate-severe renal insufficiency, etc; 8.Time for quitting smoking less than 3 weeks; 9.Cases rejecting to sign the informed consent; 10.Other conditions not appropriate to the RCT judging by researchers.

Design outcomes

Primary

MeasureTime frame
Time of surgery;Blood loss in intraoperative period;

Secondary

MeasureTime frame
Blood routine examination;Blood biochemical examination;T-lymphocyte subsets examination;Postoperative complications;Recovery of pulmonary function;Recovery of thorax;Degree of postoperative pain;Time of drainage;Gross volume of postoperative plural effusion;Life quality score;Length of stay;Hospitalization expense;

Countries

China

Contacts

Public ContactYao Xiaojun

The Public Health Clinical Center of Chengdu

flyingyao@163.com+86 19180688426

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026