UMIN-CTR Clinical Trial

Basic information
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
Condition	inguinal hernia
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Intraoperative adverse events
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Teikyo University
Institute
Department

Funding Source
Organization	Intuitive Surgical Sarl
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
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

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

Management information
Registered date	2021 Year 11 Month 11 Day
Last modified on	2022 Year 11 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052559