UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062797 |
|---|---|
| Receipt number | R000071869 |
| Scientific Title | A Randomized Controlled Trial of Single-Incision Laparoscopic Appendectomy via Pfannenstiel versus Umbilical Incision for Acute Appendicitis |
| Date of disclosure of the study information | 2026/09/03 |
| Last modified on | 2026/09/03 10:20:50 |
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Basic information
Public title
A Randomized Controlled Trial of Single-Incision Laparoscopic Appendectomy via Pfannenstiel versus Umbilical Incision for Acute Appendicitis
Acronym
Pfannenstiel versus Umbilical Incision for Acute Appendicitis
Scientific Title
A Randomized Controlled Trial of Single-Incision Laparoscopic Appendectomy via Pfannenstiel versus Umbilical Incision for Acute Appendicitis
Scientific Title:Acronym
Pfannenstiel vs Umbilical TANKO Trial
Region
| Japan |
Condition
Condition
Acute appendicitis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare Pfannenstiel and umbilical incisions for single-incision laparoscopic appendectomy in patients with acute appendicitis and to evaluate the efficacy and safety of the two approaches, with postoperative pain as the primary outcome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Numerical Rating Scale (NRS) score for pain during movement at 48 hours after surgery
Key secondary outcomes
Pain NRS scores at 6, 24, and 72 hours and 30 days after surgery; cosmetic satisfaction NRS score at 30 days after surgery; operative time; blood loss; length of hospital stay; incidence of surgical site infection (SSI) within 30 days after surgery; additional port placement; conversion to open surgery; unplanned revisit and readmission; SSI, incisional hernia, and adhesive bowel obstruction at 3 months after surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Single-incision laparoscopic appendectomy via a Pfannenstiel incision
Interventions/Control_2
Single-incision laparoscopic appendectomy via an umbilical incision
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older.
Patients diagnosed with acute appendicitis and considered eligible for single-incision laparoscopic appendectomy.
Patients who have received an explanation of the study using the written informed consent document and provided written informed consent themselves, or, when the patient is unable to provide consent, whose legally acceptable representative has provided written informed consent.
Key exclusion criteria
Patients with suspected appendiceal tumor or appendiceal cancer before surgery.
Pregnant patients.
Patients with severe obesity (BMI 35 kg/m2 or higher).
Patients in whom laparoscopic surgery is strongly considered difficult because of a history of abdominal surgery or other reasons.
Patients considered unsuitable for participation in this study by the principal investigator or study investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuda |
| Middle name | |
| Last name | Tomohiko |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Department of Gastroenterological Surgery
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba
TEL
0476991111
t-yasuda@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yasuda |
| Middle name | |
| Last name | Tomohiko |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Department of Gastroenterological Surgery
Zip code
2701694
Address
1715 Kamagari, Inzai, Chiba
TEL
0476991111
Homepage URL
t-yasuda@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Central Ethics Committee of the Nippon Medical School Foundation
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
chuorinri.group@nms.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
日本医科大学千葉北総病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 03 | 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
| 2026 | Year | 04 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071869
