Unique ID issued by UMIN | UMIN000015340 |
---|---|
Receipt number | R000017654 |
Scientific Title | Randomized control study comparing quality of life after single-port versus conventional 3-port video-assisted thoracoscopic surgery |
Date of disclosure of the study information | 2014/10/03 |
Last modified on | 2023/10/10 14:31:38 |
Randomized control study comparing quality of life after single-port versus conventional 3-port video-assisted thoracoscopic surgery
Randomized control study comparing single-port versus 3-port video-assisted thoracoscopic surgery
Randomized control study comparing quality of life after single-port versus conventional 3-port video-assisted thoracoscopic surgery
Randomized control study comparing single-port versus 3-port video-assisted thoracoscopic surgery
Japan |
primary lung cancer, metastatic lung cancer, benign tumor of the lung, pneumothorax
Chest surgery |
Malignancy
NO
Randomized control study comparing quality of life after single-port versus conventional 3-port video-assisted thoracoscopic surgery
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
degree of postoperative pain (POD 1, Numeric Rating Scale (NRS))
intraoperative blood loss, duration of the surgical procedure, frequency of intraoperative and postoperative complications, distance from nodules or bullae to be resected to the edges, degree of postoperative pain (POD 2 to 5, Numeric Rating Scale (NRS)), frequency in use of analgesics, patient satisfaction score, postoperative pulmonary function, 6-munutes walk, CRP, WBC count, duration of drainage, postoperative hospital stay
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Maneuver |
single-port video-assisted thoracoscopic surgery partial resection
Conventional 3-port video-assisted thoracoscopic surgery partial resection
20 | years-old | <= |
Not applicable |
Male and Female
(1)Patients who need to undergo thoracoscopic lung partial resection for primary lung cancer, metastatic lung cancer, benign lung tumor, inflammatory lung nodule, or spontaneous pneumothorax
(2)Patients who are tolerable for general anesthesia
(3)Patients who are over 20 years of age at the time of consent
(4)Patients who have not gotten ipsilateral thoracic surgery
(5)Patients who received informed consent to attend this study, and the agreements are provided in a document
(1) Severe pulmonary diseases
(2) Respiratory tract infection
(3) Severe circulatory diseases
(4) When performing another operation concurrently
(5) Obesity (BMI:Body Mass Index over 35)
(6) Suspected cases of pregnancy
(7) Patients with mental disorder or dementia
(8) Patients who are judged ineligible by the investigator and the attending surgeon
84
1st name | Sano |
Middle name | |
Last name | Yoshifumi |
Ehime University Hospital
Center of Chest Medicine and Surgery
791-0295
454 Shitsukawa, Toon City 791-0295, JAPAN
81-89-960-5331
ysano@m.ehime-u.ac.jp
1st name | YS |
Middle name | |
Last name | Yoshifumi |
Ehime University Hospital
Center of Chest Medicine and Surgery
791-0295
454 Shitsukawa, Toon City 791-0295, JAPAN
+81899605331
ysano@m.ehime-u.ac.jp
Center of Chest Medicine and Surgery, Ehime University Hospital
Department of Cardiovascular and Thoracic Surgery, Ehime University Graduate School of Medicine
Self funding
Japan
Clinical Research Support Center, Ehime University Hospital
454 Shitsukawa, Toon 791-0295, JAPAN
+81899605331
ysano@m.ehime-u.ac.jp
NO
愛媛大学医学部附属病院
(Ehime University Hospital)
2014 | Year | 10 | Month | 03 | Day |
https://link.springer.com/article/10.1007/s00595-021-02294-6
Published
https://link.springer.com/article/10.1007/s00595-021-02294-6
84
In this prospective randomized controlled study comparing the efficacy of uniportal VATS with that of conventional 3-port VATS, the primary endpoint was not met, but it showed that pain on PODs 2, 3, 5, and 10 was mild, and the PSS was high. Thus, uniportal VATS is associated with improved levels of chest pain and patient satisfaction in the early stage postoperatively, without differences in complication rates and surgical margins from the lesions.
2023 | Year | 10 | Month | 10 | Day |
This was a prospective, randomized, open-labeled, single-institution, two-arm, parallel-group, superiority trial, approved by the Ethics Committee of Ehime University Hospital (approval number, 1409011). Before trial commencement, the protocol was registered in the University Hospital Medical Information Network Clinical Trial Registry (registration number: UMIN000015340 http://www.umin.ac.jp/english/). Between October 2014 and August 2017, 84 patients with pulmonary nodules or isolated bullous formations were randomized to undergo uniportal (n=42) or
conventional 3-port (n=42) VATS for partial resection of the lung
We explained the procedure to the patients and obtained their informed consent. After registration, randomization was conducted, and the patients were divided into two groups: the uniVATS (uniportal) group and the conventional 3-port VATS (conventional) group.
One of the 42 participants in the 3-Port group refused to participate after Randmized, so the analysis was performed with 42 participants in the monoport group and 41 in the 3-Port group.
No adverse events were observed.
This trial enrolled 84 patients, but after 1 patient withdrew consent, 42 were assigned to the uniportal group and 41 to the conventional group. The primary disease was a neoplastic lesion in 81 patients and a cystic lesion in 2. No surgery-related deaths were recorded in either group and none of the patients in the uniportal group required conversion to multiportal VATS or thoracotomy.No diferences were found between the groups in background factors, such as age and sex; operative factors, such as estimated blood loss and operative time; or oncologic factors, such as the number of lesions, tumor size, and tumor or bulla margins. There were also no diferences between the groups in procedure-related factors such as complication rate, duration of chest tube drainage, and hospital stay. Finally, no signifcant diferences were found between the groups in the CRP level and WBC count preoperatively or on PODs 1, 2, 4, 5, and 10; or in the VC, FEV1, and 6MWT preoperatively or on PODs 5 and 10.Figure 4 and Table 2 show that the NRS scores in the two groups on POD 1were not signifcantly diferent, but that on PODs 2, 3, 5, and 10, they were lower in the uniportal group than in the conventional group. There was no diference in the use of analgesia between the groups. Postoperative pain tended to be less severe in the uniportal group throughout the entire course. Furthermore, we examined the percentage of patients with NRS 0 in both groups. Clearly that the percentage of patients with NRS 0 was higher in the uniportal group than in the conventional group. The PSS on PODs 5 and 10 in both groups. The patients in the uniportal group expressed a higher level of satisfaction aftertheir procedure than those in the conventional group.
The primary endpoint of this study was postoperative pain assessed by using the numeric rating scale (NRS) ranging from 0 to 10 at rest (0, no pain; 10, worst imaginable pain) on the morning of postoperative day (POD) 1.
The secondary endpoints were estimated blood loss, operative time, complication rate, NRS score on PODs 2, 3, 4, 5, and 10, analgesic requirement, and patient satisfaction score (PSS; grading, 0-5), vital capacity (VC), forced expiratory volume in 1s (FEV1), 6-min walk test (6MWT) results on PODs 5 and 10, C-reactive protein (CRP) levels, white blood cell (WBC) count, duration of chest tube drainage, and duration of hospital stay. Additionally, curability was evaluated by the distance from the tumor or bullous formation to the resected margin.
Completed
2014 | Year | 09 | Month | 22 | Day |
2014 | Year | 09 | Month | 22 | Day |
2014 | Year | 10 | Month | 03 | Day |
2018 | Year | 09 | Month | 30 | Day |
2019 | Year | 04 | Month | 07 | Day |
2019 | Year | 04 | Month | 07 | Day |
2019 | Year | 06 | Month | 10 | Day |
2014 | Year | 10 | Month | 03 | Day |
2023 | Year | 10 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017654
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |