UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062182 |
|---|---|
| Receipt number | R000071157 |
| Scientific Title | Construction of a Progressive Tubeless Day Surgery System for Laparoscopic Adrenal Tumors Based on an Original Stratified Risk Control Concept |
| Date of disclosure of the study information | 2026/07/09 |
| Last modified on | 2026/07/09 00:22:11 |
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Basic information
Public title
A Progressive Tubeless Day Surgery Mode for Laparoscopic Adrenal Tumors with Preoperative Bleeding Risk Stratification
Acronym
A-Tubeless-Day-Laparoscopic-Adrenal-Bleeding-Stratification
Scientific Title
Construction of a Progressive Tubeless Day Surgery System for Laparoscopic Adrenal Tumors Based on an Original Stratified Risk Control Concept
Scientific Title:Acronym
Stratified Risk Tubeless Adrenal Day Surgery
Region
| Asia(except Japan) |
Condition
Condition
Adrenal Tumors, Adrenal Adenoma, Functional Adrenal Mass
Classification by specialty
| Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a standardized progressive tubeless day surgery system for laparoscopic adrenal tumors based on self-developed preoperative stratified bleeding risk control criteria. We aim to verify the clinical safety and recovery advantages of risk-stratified perioperative ERAS management, compare the differences in perioperative indicators between low and high bleeding risk groups, and evaluate the health economic benefits of the 48-hour tubeless day surgery model for adrenal tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative blood loss measured during laparoscopic adrenal tumor resection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Progressive tubeless laparoscopic adrenal tumor resection combined with 48-hour ERAS day-surgery protocol for patients satisfying all general inclusion criteria and seven low intraoperative bleeding risk standards. No drainage tube is placed after operation, and standardized short-stay perioperative management is adopted.
Interventions/Control_2
Conventional laparoscopic adrenal tumor resection with routine placement of postoperative drainage tube for patients meeting all general inclusion criteria but failing to satisfy the seven low intraoperative bleeding risk standards. Standard ordinary inpatient management is adopted instead of tubeless treatment and 48-hour day-surgery mode.
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Imaging-confirmed adrenal space-occupying lesions, scheduled for retroperitoneal laparoscopic adrenal tumor resection;
Complete clinical and intraoperative data available to assess seven intraoperative bleeding risk indicators;
Patients and their families provide informed consent and voluntarily cooperate with full-course follow-up.
Key exclusion criteria
Patients undergoing open or robotic adrenal tumor resection;
Severe preoperative coagulation disorders with inability to discontinue anticoagulant/antiplatelet drugs;
Combined end-stage cardiac, pulmonary, hepatic or renal failure intolerant to short-term enhanced recovery management;
Cases with missing key clinical or intraoperative data, refusal of follow-up, or voluntary withdrawal during the study.
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Yan |
| Middle name | |
| Last name | Zhao |
Organization
Xuzhou Cancer Hospital
Division name
Department of Urology
Zip code
221000
Address
No.131 Huancheng Road, Gulou District, Xuzhou City, Jiangsu Province, P.R.China
TEL
+8615996959302
529735655@qq.com
Public contact
Name of contact person
| 1st name | Ya |
| Middle name | Sheng |
| Last name | Cao |
Organization
Xuzhou Cancer Hospital
Division name
Department of Science and Education
Zip code
221000
Address
No.131 Huancheng Road, Gulou District, Xuzhou City, Jiangsu Province, P.R.China
TEL
+8619105168987
Homepage URL
xzsykjk@163.com
Sponsor or person
Institute
Xuzhou Cancer Hospital
Institute
Department
Personal name
Funding Source
Organization
Xuzhou Cancer Hospital
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
Xuzhou Cancer Hospital
Address
No.131 Huancheng Road, Gulou District, Xuzhou City, Jiangsu Province, P.R.China
Tel
+8619105168987
xzsykjk@163.com
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
Xuzhou Cancer Hospital
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 09 | 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 | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 12 | 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 | 07 | Month | 09 | Day |
Last modified on
| 2026 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071157
