A Single-Center Randomized Controlled Trial Evaluating the Air Leakage of Staple Line Reinforcements in Anatomic Pulmonary Resectio

Phase 2

Recruiting

• Conditions: Diseases requiring anatomical lobectomy or segmentectomy in thoracic surgery

• Registration Number: JPRN-jRCT1032220620
• Lead Sponsor: Suzuki Hidemi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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