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PGA sheet's effect on the recurrence of spontaneous pneumothorax, Randomized trial

Multicenter Randomized Comparative Study of postsurgical recurrence of spontaneous pneumothorax: Bullae Resection versus Bullae Resection plus Polyglycolic Acid Sheet Coverage - PANDA trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040352
Enrollment
200
Registered
2020-07-01
Start date
2021-12-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Primary spontaneous pneumothorax

Interventions

VATS bullectomy only. PGA sheet coverage on the staple line of VATS bullectomy

Sponsors

Department of Thoracic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan
Lead Sponsor
Gifu Prefectural Tajimi Hospital Shimada Municipal Hospiptal
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who have spontaneous pneumothorax diagnosed by radiography and plan to underwent VATS bullectomy. 2)Patients who receive informed consent to attend this study, and the agreements are provided in a document. The consent of parents are also required, in case patients are under 20-years old.

Exclusion criteria

Exclusion criteria: 1) Patients with allergy to polyglycol acid. 2) History of ipsilateral chest surgery. 3) History of ipsilateral pleurodesis or autologous blood patch pleurodesis. 4) Patients with infections requiring active treatment 5) Pregnant or breast-feeding patients. 6) Patients who are judged ineligible by the investigator and the attending surgeon.

Design outcomes

Primary

MeasureTime frame
Rates of ipsilateral pneumothorax recurrence detected by radiography

Secondary

MeasureTime frame
Complication rates, surgical duration, blood loss, Reoperation rate for recurrent pneumothorax

Countries

Japan

Contacts

Public ContactYuka Kadomatsu

Nagoya University Graduate School of Medicine Department of Thoracic Surgery

ykadomatsu@med.nagoya-u.ac.jp052-744-2375

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026