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A prospective, single-center, randomized, open-label, parallel-controlled clinical study on the efficacy and safety of single-port thoracoscopic surgery for pulmonary nodules using a single-port linear cut stapler

A prospective, single-center, randomized, open-label, parallel-controlled clinical study on the efficacy and safety of single-port thoracoscopic surgery for pulmonary nodules using a single-port linear cut stapler

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089202
Enrollment
Unknown
Registered
2024-09-03
Start date
2024-09-08
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

Lung cancer

Interventions

Study group:Use electric cutting stapler
Control group1:Use endoscopic cutting stapler (manual)
Control group2:Use endoscopic joint head linear cutting stapler (manual)

Sponsors

Meishan People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-80(including 18 and 80) , male or female; 2. Single-port thoracoscopic surgery for pulmonary nodules ; 3. American Society of Anesthesiologists (ASA-RRB- grI-III-III patients; 4. Patients or legal representatives agreed to participate in the trial, and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. PT was prolonged for 2 seconds or INR was 1.2 beyond the upper limit of normal value. 2 Those who know or suspect that the subject is allergic to the test product. 3.Patients with severe liver, kidney, heart and lung dysfunction or hemodynamics instability. 4. Patients who had undergone thoracic surgery within 3 months. 5. A woman who is lactating or pregnant. 6. Other conditions were not considered suitable for the study.

Design outcomes

Primary

MeasureTime frame
Operation Time;Lung leak;

Secondary

MeasureTime frame
Match success rate;Amount of bleeding;The researchers rated the Stapler's performance satisfaction; VAS scores;Extubation time;Postoperative hospital stay; Total cost of treatment;Number of readmissions;Adverse events;

Countries

China

Contacts

Public ContactKan Qiwei

Meishan People's Hospital

646967480@qq.com+86 138 0816 6485

Outcome results

None listed

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