UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043184 |
|---|---|
| Receipt number | R000048824 |
| Scientific Title | Short-term results of laparoscopic inguinal hernia repair: A prospective observational study |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2023/02/01 09:11:32 |
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Basic information
Public title
Short-term results of laparoscopic inguinal hernia repair: A prospective observational study
Acronym
Short term results of Lap hernia repair in Japan
Scientific Title
Short-term results of laparoscopic inguinal hernia repair: A prospective observational study
Scientific Title:Acronym
Short term results of Lap hernia repair in Japan
Region
| Japan |
Condition
Condition
Inguinal Hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this prospective study is to determine the complication rate at 3 months after laparoscopic inguinal hernia repair in Japan.
Basic objectives2
Others
Basic objectives -Others
1. Frequency of chronic pain
2. Pain at the end of 3 months after laparoscopic inguinal hernia repair
3. Frequency of subcutaneous bleeding and scrotal hematoma,
4. Frequency of Seroma
5. Time required to return to daily life after the surgery.
6. Time required to return to social life after the surgery.
7. Satisfaction with the surgery
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The complication rate at 3 months after laparoscopic inguinal hernia repair in Japan.
Key secondary outcomes
1. Frequency of chronic pain
2. Pain at the end of 3 months after laparoscopic inguinal hernia repair
3. Frequency of subcutaneous bleeding and scrotal hematoma,
4. Frequency of Seroma
5. Time required to return to daily life after the surgery.
6. Time required to return to social life after the surgery.
7. Satisfaction with the surgery
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 who agreed to participate in this study.
2. Adults aged over 20 years of age
3. Unilateral cases.
Key exclusion criteria
1. Patients with a history of lower abdominal surgery (excluding appendicitis surgery without peritonitis and contralateral inguinal hernia surgery)
2. Patients with a history of laparotomy in the upper abdomen (excluding cases of laparoscopic surgery in the upper abdomen)
3. Cases that require tacking to Danger Zone
4. Emergency surgery
5. Scrotal hernia
6. Non-reducible hernia
7. Recurrent hernia
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Hirano |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery II
Zip code
060-8638
Address
KIta 15 nishi 7, Kita Ward, Sapporo
TEL
0117067714
satto@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Saseem |
| Middle name | |
| Last name | Poudel |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery II
Zip code
060-8638
Address
KIta 15 nishi 7, Kita Ward, Sapporo
TEL
0117067714
Homepage URL
saseem@gmail.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Self Funded
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Steel Memorial Muroran Hospital
Gi Surgery Clinic
Teine Keijinkai Hospital
Hokkaido Medical Center
Yao Municipal Hospital
Shiroyama Hospital
Hyogo Prefectural Kakogawa Medical Center
JA Hiroshima General Hospital
Kousekai Hospital
Yotsuya Medical Cube
Sagamihara Kyodo Hospital
Tsuchiura Kyodo Hospital
Itoigawa General Hospital
JCHO Osaka Hospital
Nishinomiya Municipal Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Graduate School of Medicine
Address
KIta 15 nishi 7, Kita ward, Sapporo
Tel
011-706-5003
shomu@med.hokudai.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
製鉄室蘭病院 （北海道）
Gi外科クリニック（岡山県）
手稲渓仁会病院（北海道）
北海道医療センター（北海道）
八尾市立病院（大阪府）
城山病院（大阪府）
JA広島総合病院（広島県）
光晴会病院（長崎県）
兵庫県立加古川医療センター（兵庫県）
四谷メディカルキューブ（東京都）
相模原協同病院（神奈川県）
土浦協同病院（茨城県）
糸魚川総合病院（新潟県）
JCHO大阪病院（大阪府）
西宮市立中央病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 31 | Day |
Other
Other related information
Primary endpoint:
Complications rate at 3 months after surgery
Secondary endpoint:
1. Frequency of chronic pain
2. Pain at the end of 3 months after laparoscopic inguinal hernia repair
3. Frequency of subcutaneous bleeding and scrotal hematoma,
4. Frequency of Seroma
5. Time required to return to daily life after the surgery.
6. Time required to return to social life after the surgery.
7. Satisfaction with the surgery
Management information
Registered date
| 2021 | Year | 01 | Month | 30 | Day |
Last modified on
| 2023 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048824
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
