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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046048
Receipt No. R000052559
Scientific Title Evaluation of short-term outcomes of robot-assisted inguinal hernia repair for primary groin hernia patients -Multicenter, Prospective cohort study-
Date of disclosure of the study information 2021/11/15
Last modified on 2021/11/11

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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 EP-CRSU Co., Ltd.
Division name CRM2
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
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 Preinitiation
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 03 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
2021 Year 11 Month 11 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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