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

JRCT ID: jRCT1032220620

Registered date:09/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diseases requiring anatomical lobectomy or segmentectomy in thoracic surgery
• Date of first enrollment: 09/02/2023
• Target sample size: 120
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

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

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 90age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Suzuki Hidemi
• Source(s) of Monetary Support: Clinical Research Initiation-Fund (of Chiba University Hospital)