臨床研究等提出・公開システム

A Single-Center Randomized Controlled Trial Evaluating the Air Leakage of Staple Line Reinforcements in Anatomic Pulmonary Resection (Trial of Evaluating of Air Leakage using Staple Line Reinforcements)

A Single-Center Randomized Controlled Trial Evaluating the Air Leakage of Staple Line Reinforcements in Anatomic Pulmonary Resection (Trial of Evaluating of Air Leakage using Staple Line Reinforcements)

Suzuki Hidemi

Chiba University Hospital

1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan

h-suzuki@chiba-u.jp

Yusa Jotaro

Chiba University Hospital

1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan

+81-43-226-2547

ccwa4980@chiba-u.jp

Recruiting

Feb. 09, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) 18 to 90 years of age
2) Anatomical pulmonary resection (lobectomy or segmentectomy) using an automated suturing device is planned.
3) Patient is considered to have lobar insufficiency on preoperative chest CT and is considered to require an automated suturing device for pulmonary resection.
4) ECOG performance status (PS) is 0-1.
5) Main organ function is preserved.
6) The patient's consent to participate in this study has been obtained in writing.

1) Wedge resection.
2) Patient with multiple lobectomy or segmentectomy that will not result in en bloc resection.
3) Patient who is considered to be completely lobulated on preoperative chest CT and is considered not to require an automated suturing device for pulmonary resection.
4) Patient with dementia or other conditions that require consent from legally authorized representative
5) Patients who may exhibit allergic reactions to the device to be used.
6) Patients deemed by the investigator to be unsuitable for the safe conduct of this study

Both

Diseases requiring anatomical lobectomy or segmentectomy in thoracic surgery

1) Eligible and consenting patients will be pre-assigned to use or not use staple line reinforcements in the automated suturing devise.
2) Intraoperative air leakage will be evaluated at and the staple line using the automated sutureing device in each group.
3) Measure the time (minutes) required to repair the intraoperative air leakage.
4) Evaluate the duration of chest drainage tube placement (days).
5) Evaluate the presence or absence of additional procedures (e.g., surgical closure of air leakage, pleurodesis, etc.).
6) Evaluate the presence or absence of delayed air leakage.

Intraoperative air leakage from staple line and its vicinity in anatomic pulmonary resection using an automated suturing device with staple line reinforcement.

1) Time required to repair intraoperative air leakage.
2) Duration of postoperative chest drainage tube placement.
3) Evaluate the presence or absence of additional procedures.
4) Evaluate presence of delayed air leakage.
5) Evaluate intraoperative and postoperative air leakage due to different automated suturing devices.
6) Evaluate intraoperative air leakage,postoperative air leakage or delayed air leakage due to surgical
procedures.
7) Number of automated suturing devices used for pulmonary resection.

+81-43-226-2616

Jan. 18, 2023

none