UMIN-CTR Clinical Trial

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

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Basic information

Public title

Randomized control study comparing quality of life after single-port versus conventional 3-port video-assisted thoracoscopic surgery

Acronym

Randomized control study comparing single-port versus 3-port video-assisted thoracoscopic surgery

Scientific Title

Randomized control study comparing quality of life after single-port versus conventional 3-port video-assisted thoracoscopic surgery

Scientific Title:Acronym

Randomized control study comparing single-port versus 3-port video-assisted thoracoscopic surgery

Region

Japan


Condition

Condition

primary lung cancer, metastatic lung cancer, benign tumor of the lung, pneumothorax

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Randomized control study comparing quality of life after single-port versus conventional 3-port video-assisted thoracoscopic surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

degree of postoperative pain (POD 1, Numeric Rating Scale (NRS))

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

single-port video-assisted thoracoscopic surgery partial resection

Interventions/Control_2

Conventional 3-port video-assisted thoracoscopic surgery partial resection

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(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

Key exclusion criteria

(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

Target sample size

84


Research contact person

Name of lead principal investigator

1st name Sano
Middle name
Last name Yoshifumi

Organization

Ehime University Hospital

Division name

Center of Chest Medicine and Surgery

Zip code

791-0295

Address

454 Shitsukawa, Toon City 791-0295, JAPAN

TEL

81-89-960-5331

Email

ysano@m.ehime-u.ac.jp


Public contact

Name of contact person

1st name YS
Middle name
Last name Yoshifumi

Organization

Ehime University Hospital

Division name

Center of Chest Medicine and Surgery

Zip code

791-0295

Address

454 Shitsukawa, Toon City 791-0295, JAPAN

TEL

+81899605331

Homepage URL


Email

ysano@m.ehime-u.ac.jp


Sponsor or person

Institute

Center of Chest Medicine and Surgery, Ehime University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiovascular and Thoracic Surgery, Ehime University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research Support Center, Ehime University Hospital

Address

454 Shitsukawa, Toon 791-0295, JAPAN

Tel

+81899605331

Email

ysano@m.ehime-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

愛媛大学医学部附属病院
(Ehime University Hospital)


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 03 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007/s00595-021-02294-6

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s00595-021-02294-6

Number of participants that the trial has enrolled

84

Results

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.

Results date posted

2023 Year 10 Month 10 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

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

Participant flow

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.

Adverse events

No adverse events were observed.

Outcome measures

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.

Plan to share IPD


IPD sharing Plan description

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.


Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 09 Month 22 Day

Date of IRB

2014 Year 09 Month 22 Day

Anticipated trial start date

2014 Year 10 Month 03 Day

Last follow-up date

2018 Year 09 Month 30 Day

Date of closure to data entry

2019 Year 04 Month 07 Day

Date trial data considered complete

2019 Year 04 Month 07 Day

Date analysis concluded

2019 Year 06 Month 10 Day


Other

Other related information



Management information

Registered date

2014 Year 10 Month 03 Day

Last modified on

2023 Year 10 Month 10 Day



Link to view the page

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