UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063218 |
|---|---|
| Receipt number | R000071972 |
| Scientific Title | Comparison of clinical outcomes between transumbilical and supraumbilical incisions for camera-port placement in laparoscopic inguinal hernia repair: a randomized controlled trial |
| Date of disclosure of the study information | 2026/10/08 |
| Last modified on | 2026/10/08 15:31:19 |
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Basic information
Public title
A study comparing transumbilical and supraumbilical incisions for camera-port placement in laparoscopic inguinal hernia repair
Acronym
UI-RCT
Scientific Title
Comparison of clinical outcomes between transumbilical and supraumbilical incisions for camera-port placement in laparoscopic inguinal hernia repair: a randomized controlled trial
Scientific Title:Acronym
UI-RCT
Region
| Japan |
Condition
Condition
Inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to compare the clinical utility of transumbilical and supraumbilical incisions for camera-port placement in transabdominal preperitoneal repair (TAPP) and to contribute to establishing the optimal surgical technique.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Wound pain at the camera-port insertion site on postoperative day 1 (24 +/- 6 hours after surgery), assessed by the patient using a visual analog scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Key secondary outcomes
1. Operative time, defined as the time from the start to the end of surgery.
2. Incidence of surgical site infection (SSI) at 1 week and 1 month after surgery.
3. Quality of life assessed using the EQ-5D-5L before surgery and at 1 month and 1 year after surgery.
4. Cosmetic satisfaction assessed using the Body Image Scale at 1 year after surgery.
5. Incidence of incisional hernia at the camera-port insertion site at 1 year after surgery, assessed by abdominal computed tomography.
6. Wound pain at the camera-port insertion site at 3 hours, 1 week, and 1 month after surgery, assessed using the visual analog scale (VAS), and the number of analgesic doses used.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Transumbilical incision group: During laparoscopic inguinal hernia repair using the transabdominal preperitoneal approach, a skin incision is made within the umbilical depression, and a 10-mm camera port is inserted into the abdominal cavity using an open technique.
Interventions/Control_2
Supraumbilical incision group: During laparoscopic inguinal hernia repair using the transabdominal preperitoneal approach, a transverse skin incision is made above the umbilical depression, and a 10-mm camera port is inserted into the abdominal cavity using an open technique.
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 aged 20 years or older.
2. Patients diagnosed with inguinal hernia based on clinical findings or imaging examinations.
3. Patients considered eligible for laparoscopic inguinal hernia repair using the transabdominal preperitoneal approach.
4. Patients who provide written informed consent before enrollment in the study.
Key exclusion criteria
1. Patients with confirmed or strongly suspected infection at the planned incision site or within the abdominal cavity.
2. Patients with recurrent inguinal hernia.
3. Patients with bilateral inguinal hernia.
4. Patients requiring emergency surgery because of incarceration, perforation, or other conditions.
5. Patients with a previous laparotomy scar at or around the umbilicus.
6. Patients with concomitant umbilical hernia.
7. Patients with renal dysfunction requiring dialysis.
8. Patients who are pregnant or may be pregnant.
9. Patients considered unsuitable for participation in this study by the attending physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Kawamura |
Organization
Southern Tohoku General Hospital
Division name
Department of Surgery
Zip code
963-8563
Address
7-115 Yatsuyamada, Koriyama, Fukushima 963-8563, Japan
TEL
024-934-5322
hidetaka0716.hk@gmail.com
Public contact
Name of contact person
| 1st name | Hidetaka |
| Middle name | |
| Last name | Kawamura |
Organization
Southern Tohoku General Hospital
Division name
Department of Surgery
Zip code
963-8563
Address
7-115 Yatsuyamada, Koriyama, Fukushima 963-8563, Japan
TEL
024-934-5322
Homepage URL
hidetaka0716.hk@gmail.com
Sponsor or person
Institute
Southern Tohoku General Hospital
Institute
Department
Personal name
Hidetaka Kawamura
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Minimally Invasive Surgical and Medical Oncology, Fukushima Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Southern Tohoku Research Institute for Neuroscience
Address
7-115 Yatsuyamada, Koriyama, Fukushima 963-8563, Japan
Tel
024-934-5322
rinri@mt.strins.or.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
総合南東北病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 08 | 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
No
IPD sharing Plan description
There is currently no plan to share de-identified individual participant data.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2030 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 08 | Day |
Last modified on
| 2026 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071972
