UMIN-CTR Clinical Trial

Public title

prospective survey on relation between the postoperative pain and the number or site of intercostal ports in robotic or video-assisted thoracic surgery

Acronym

prospective survey on postoperative pain in robotic or video-assisted thoracic surgery

Scientific Title

Japan Robot-Assisted Thoracic Surgery Interest Group Trial 01

Scientific Title:Acronym

postoperative pain in robotic or video-assisted thoracic surgery (J-RATSIG 01)

Region

Japan

Condition

robotic or video-assisted thoracic surgery for lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To compare the postoperative pain between robotic and video-assisted thoracic surgeries

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

the rate of Numeric Rating Scale of 3 or less on 30th day after surgery

Key secondary outcomes

Pain scores on 10th, 30th, and 90th days after surgery

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) 20 years and over
2) Patients who underwent robotic or thoracoscopic lobectomy or segmental resection for lung cancer (including metastatic lung cancer, with or without lymph node dissection)
3) Being able to confirm the patient background in the medical record
4) The maximum wound is 5 cm or less (no thoracotomy device is used)
5) No renal dysfunction (eGFR 40 mL / min or more)
6) No history of open chest surgery (including thoracoscopic surgery) (including contralateral side)
7) Those who have obtained written consent for participation in the research

Key exclusion criteria

1) Patients whose drain was not removed by 7 days after surgery
2) Patients with Grade 3 or higher complications according to the Clavien-Dindo classification (However, postoperative pain of G3 or higher is not excluded)
3) Patients with chest pain before lung cancer surgery
4) Patients using opioids or steroids before lung cancer surgery due to other diseases
5) Patients who are judged by the principal investigator / coordinator to be inappropriate for inclusion in the study

Target sample size

400

Name of lead principal investigator

1st name	Koji
Middle name
Last name	Kawaguchi

Organization

Mie University Hospital

Division name

Thoracic surgery

Zip code

514-8507

Address

2-174, Edobashi, Tsu

TEL

0592315021

Email

k-gucci@clin.medic.mie-u.ac.jp

Name of contact person

1st name	Koji
Middle name
Last name	Kawaguchi

Organization

Mie University Graduate School of Medicine

Division name

Thoracic surgery

Zip code

5148507

Address

2-174, Edobashi, Tsu

TEL

0592315021

Homepage URL

Email

k-gucci@clin.medic.mie-u.ac.jp

Institute

Mie University Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

a. Department of Thoracic and Cardiovascular Surgery, Mie University, Tsu, Japan.
b. Clinical Research Support Center, Mie University Hospital, Tsu, Japan.
c. Division of Thoracic Surgery, Respiratory Disease Center, Seirei Mikatahara General Hospital, Hamamatsu, Japan
d. Division of Thoracic Surgery, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
e. Department of Thoracic Surgery, Toyohashi Municipal Hospital, Toyohashi, Japan
f. Department of Thoracic Surgery, Aichi Cancer Center, Nagoya, Japan
g. Department of Thoracic Surgery, Okayama University, Okayama, Japan
h. Department of Thoracic Surgery, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, Nagoya, Japan
i. Department of Thoracic Surgery, Hyogo Medical University, Nishinomiya, Japan
j. Department of Thoracic Surgery, Nagoya University, Nagoya, Japan
k. Department of Thoracic Surgery, Sapporo Medical University, Sapporo, Japan
l. Department of Thoracic Surgery, Kanazawa University, Kanazawa, Japan
m. Department of Thoracic Surgery, Toyota Memorial Hospital, Toyota, Japan

Name of secondary funder(s)

Organization

the Clinical Research Ethics Review Committee of Mie University Hospital

Address

2-174, Edobashi, Tsu

Tel

0592315021

Email

kk-sien@med.mie-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

三重大学（三重県）、名古屋大学（愛知県）、名古屋第一赤十字病院（愛知県）、聖隷三方原病院（静岡県）、岡山大学（岡山県）、兵庫医科大学（兵庫県）、トヨタ記念病院（愛知県）、豊橋市民病院（愛知県）、近畿大学（大阪）、愛知県がんセンター中央病院（愛知県）

Date of disclosure of the study information

2020

Year

11

Month

25

Day

URL releasing protocol

https://www.sciencedirect.com/science/article/pii/S0169500224004951?via%3Dihub

Publication of results

Partially published

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S0169500224004951?via%3Dihub

Number of participants that the trial has enrolled

405

Results

A prospective, multicenter, observational study to evaluate postoperative pain.
Not proven the noninferiority in robotic compared to thoracoscopic surgery.
Robotic approach involved more ports, longer time, and more local anesthesia.
Tumor location, port number, wound size, local anesthesia identified as risk.
Uniport surgery might be associated with less postoperative pain.

Results date posted

2025

Year

02

Month

24

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Between November 2020 and July 2022, 438 patients (RATS, n = 214; VATS, n = 224) were enrolled in this study (Fig. 1). Twelve institutions that participated in the study had at least two thoracic surgeons who performed RATS and VATS. The selection of cases and the choice of RATS or VATS were left to the policies of each institution. Thirty-three patients were excluded for the following reasons: insufficient data (n = 20), complications after enrollment (n = 6), drain not removed within seven days due to persistent air leak (n = 4), inability to complete the questionnaire due to psychiatric disorders (n = 2), and conversion to thoracotomy (n = 1). Among the patients included in this study, the response rates on POD10 and 30 were 100 % (two patients did not respond to all questionnaires). In contrast, 33 patients did not respond to the pain questionnaire on POD 90; these 33 patients were not excluded from the study population. Table 1 shows the background of 405 patients divided into the RATS and VATS groups. The average ages were 69.5 and 68.2 years, respectively and both groups showed a male predominance. The preoperative %FEV1 in the VATS group was significantly worse than that in the RATS group; however, there was no significant difference in the history of cerebral infarction, comorbid diabetes, or the smoking index. Ninety-two percent of the enrolled patients with primary lung cancer had clinical stage 0 or I disease. The other patients included 17 patients had metastatic lung cancer. In terms of surgery, the VATS group showed more evidence of pleural adhesions and more lobectomy cases (Table 2). The mean number of inserted ports was 5.0 in the RATS group (4 ports, n = 24; 5 ports, n = 158; 6 ports, n = 14 cases) and 2.2 in the VATS group (1 port, n = 99; 3 ports, n = 87; 4 ports, n = 23), which amounted to a significant difference (p < 0.01). There were also significant differences between the RATS and VATS groups in the number of injured intercostal sites (2.9 vs. 1.9, p < 0.01), largest wound size (3.4 vs. 3.7 cm, p < 0.01), sites of largest wound and drain tube placement, and operation time (202 vs. 165 min, p < 0.01). The morbidity rates within 30 days after surgery were 5.6 % in the RATS group and 4.8 % in the VATS group, whereas no mortality was detected during this period.

Participant flow

Regarding perioperative pain management, the frequency of epidural anesthesia and continuous nerve block was significantly higher in the RATS group (p = 0.002). Fig. 2 shows the changes in the percentage of patients with postoperative analgesic use between the RATS and VATS groups. None of the patients in this study had received morphine for postoperative pain management. The patients generally used acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs). Both groups showed a clear decrease in the use of analgesics within 90 days after surgery; however, the percentage of patients who received analgesics in the RATS group was significantly higher on postoperative days 10 and 30 (p = 0.001 and 0.014, respectively) and did not differ significantly on postoperative day 90 (p = 0.612).

Adverse events

Univariable and multivariable analyses were performed to clarify the risk factors for an NRS score more than 3 on postoperative day 30 (Table 3). In the univariable analysis, the approach, monitor view, number of inserted ports and injured intercostal sites, drain tube location, and epidural anesthesia or continuous nerve block were identified as statistically significant factors. In contrast, in the multivariable analysis, tumor location (upper/lower lobe, OR:2.416, 95 % CI:1.060 to 5.509, p = 0.036), number of ports (per 1 decrease, OR:0.564, 95 % CI:0.401 to 0.792, p < 0.01), largest wound size (less than 3.5 / 3.5 cm or more, OR:0.385, 95 % CI:0.179 to 0.825, p = 0.014) and epidural anesthesia or continuous nerve block (OR:3.202, 95 % CI:1.477 to 6.940, p = 0.003) were identified as significant risk factors for NRS>3 on postoperative day 30. However, the RATS approach was not a significant risk factor for postoperative pain on day 30 in the backward variable selection to obtain the final multivariable models.

Outcome measures

The primary endpoint was the percentage of patients with an NRS score less than 3 on postoperative day 30. The secondary endpoints were the NRS and painDETECT scores on postoperative days 10, 30, and 90 and the percentage of cases in which analgesics were used. In addition, we conducted a multivariable analysis to compare the factors that influenced pain on postoperative day 30.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

08

Month

21

Day

Date of IRB

2020

Year

11

Month

18

Day

Anticipated trial start date

2020

Year

11

Month

19

Day

Last follow-up date

2023

Year

07

Month

31

Day

Date of closure to data entry

2023

Year

07

Month

31

Day

Date trial data considered complete

2023

Year

07

Month

31

Day

Date analysis concluded

2024

Year

07

Month

31

Day

Other related information

A prospective, multicenter study will be conducted to compare postoperative pain in patients undergoing robotic or thoracoscopic lobectomy or segmentectomy for lung cancer. Between October 2020 and March 2022, patients who underwent robotic surgery at the research facility were informed of the consent of the study, and the same number of thoracoscopic surgery was registered. We will compare the approaches in post-pain and examine the relationship with the number and position of port wounds. The reason for setting the numbers to the same level is that there is a considerable variation in the ratio of robotic surgery and thoracoscopic surgery depending on the facility. All cases of robotic surgery will be registered, but the extraction method when there are many cases of thoracoscopic surgery will be left to each institution. However, we ask that facilities performing single-port thoracoscopic surgery register as much as possible.
This study is an observational study that does not involve invasiveness, and the current surgical procedures, pain management, drains, etc. at each facility will remain unchanged, but data for analysis will be collected.
For pain questionnaires for study subjects, use the painDETECT Japanese version published in the Pain Clinic Society (attached to a separate sheet). In order to investigate the degree of pain during the postoperative acute period (10 days after surgery) and the chronic stage (30, 90 days after surgery), we will hand over 3 pain questionnaires during hospitalization and mail them from the patient. Store the anonymization correspondence table.

Registered date

2020

Year

08

Month

22

Day

Last modified on

2025

Year

06

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047392