Clinical trial · Interventional
Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease
Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease: A Randomized Controlled Trial
NCT01575314CI-TRIAL-00020754completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the efficacy and cost difference of using a parenchymal stapling device versus hand sewing for a pulmonary lobectomy in patients with lung disease (mass or others).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of Bronchus or Lung, Unspecified | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stapling device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- stapling device
- description
- stapling device refer to patients who were randomized to use stapler for dividing lung parenchyma.
- interventionNames
- Device: stapling device
- type
- NO_INTERVENTION
- label
- hand sewn
- description
- hand sewn refer to patients who were randomized to use hand suturing for dividing lung parenchyma.
Primary outcomes (1)
- measure
- Post-operative air leak, operative time, and duration of air leak
- timeFrame
- In the operative day, after surgery, until patient can be discharged.
- description
- To compare post-operative air leakage between two groups. This data will be analyzed by fisher exact probability test. We will start observation of the air leakage at postoperative day 1. The stoping role is when statistically significant difference occur. We will measure and report in the number of patients who have post-operative air leakage.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who diagnosed lung diseases that need to perform pulmonary lobectomy Exclusion Criteria: * Patients have complete fissure. therefore, no procedure need to divide the lung parenchyma.
References
Publications (2)
- RESULTMoggi L, Giustozzi GM, Cagini L, Boselli C. [Surgical staplers in thoracic surgery]. G Chir. 1992 Apr;13(4):177-9. Italian. PMID 1637625
- DERIVEDTantraworasin A, Seateang S, Bunchungmongkol N. Staplers versus hand-sewing for pulmonary lobectomy: randomized controlled trial. Asian Cardiovasc Thorac Ann. 2014 Mar;22(3):309-14. doi: 10.1177/0218492313491754. Epub 2013 Aug 19. PMID 24585907