UMIN-CTR Clinical Trial

Public title

Evaluation of short-term outcomes of robot-assisted inguinal hernia repair for primary groin hernia patients -Multicenter, Prospective cohort study-

Acronym

ROB-HER study

Scientific Title

Evaluation of short-term outcomes of robot-assisted inguinal hernia repair for primary groin hernia patients -Multicenter, Prospective cohort study-

Scientific Title:Acronym

ROB-HER study

Region

Japan

Condition

inguinal hernia

Classification by specialty

Surgery in general

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the short-term results of R-IHR for patients with inguinal hernias, including intraoperative adverse events, surgical outcomes, postoperative recovery, postoperative complications, postoperative pain, and QOL.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Intraoperative adverse events

Key secondary outcomes

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) Patients diagnosed with primary inguinal hernia (unilateral or bilateral)
2) Patients undergoing elective inguinal hernia repair
3) Patients who agree to undergo robot-assisted inferior inguinal hernia repair at their own cost
4) Patients aged 20 years or older at enrollment (of any sex)
5) Patients who gave written informed consent to participate in the study.

Key exclusion criteria

1)ASA-PS is Class 3 or higher
2)Patients undergoing emergency surgery
3)Patients with incarcerated hernia
4)Patients undergoing surgery for recurrence (including recurrence after childhood hernia treatment) or postoperative pain
5)Patients with a history of lower abdominal surgery (including urologic/gynecologic surgery) or laparotomy (not excluding contralateral inguinal hernia surgery)
6)Patients who are unable to self-evaluation pain (e.g., dementia, psychiatric disorders)
7)Pregnant patient
8)Other patients who are deemed inappropriate by the investigator as subjects of the study

Target sample size

130

Name of lead principal investigator

1st name	Takeyuki
Middle name
Last name	Misawa

Organization

Teikyo University

Division name

Department of Surgery, School of Medicine

Zip code

173-8606

Address

2-11 Kaga, Itabashi-ku, Tokyo

TEL

0339641211

Email

misawa@med.teikyo-u.ac.jp

Name of contact person

1st name	secretariat
Middle name
Last name	ROB-HER study

Organization

EPS Corporation

Division name

Real World Evidence Business Headquarters,Clinical Research Center,CR Department 2

Zip code

162-0814

Address

Acropolis Tokyo 3F, 6-29 Shin-Ogawacho, Shinjuku-ku, Tokyo

TEL

03-5804-5045

Homepage URL

Email

prj-dvss_ih@eps.co.jp

Institute

Teikyo University

Institute

Department

Personal name

Organization

Intuitive Surgical Sarl

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Teikyo University Research Ethics Committee

Address

2-11-1 Kaga, Itabashi-ku, Tokyo

Tel

03-3964-7256

Email

turb-office@teikyo-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

Date of disclosure of the study information

2021

Year

11

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

109

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2021

Year

09

Month

16

Day

Date of IRB

2021

Year

11

Month

09

Day

Anticipated trial start date

2021

Year

11

Month

25

Day

Last follow-up date

2023

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1)Intraoperative Adverse Events (All Adverse Events/Vascular Injury with Repair/Organ Injury with Repair/Other)
2)Surgical outcomes (operative time, intraoperative blood loss, and rate of discontinuation of robotic surgery).
3)Postoperative recovery (postoperative hospital stay, days to return to daily life/sports activity/return to work)
4)Postoperative pain (incidence of acute and chronic pain/pain level/pain score [VAS]/presence of treatment for pain)
5)Postoperative complications (all complications/hematoma/seroma/urinary retention/subcutaneous hemorrhage/sexual dysfunction/others) SSI/SSO/SSOPI/
6)Rates of reoperations/readmissions/unplanned revisits
7)Recurrence rate
8)QOL(SF-36)
9)Factors Influencing Postoperative Chronic Pain/Postoperative Complications (Multivariate Analysis).
10)Learning curve

Registered date

2021

Year

11

Month

11

Day

Last modified on

2022

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052559