UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015507 |
|---|---|
| Receipt number | R000018018 |
| Scientific Title | Pancreatic fistula following laparoscopic splenectomy: impact of fibrin glue and polyglycolic acid felt on prophylaxis of postoperative complication. |
| Date of disclosure of the study information | 2014/10/23 |
| Last modified on | 2014/10/22 21:08:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Pancreatic fistula following laparoscopic splenectomy: impact of fibrin glue and polyglycolic acid felt on prophylaxis of postoperative complication.
Acronym
Impact of fibrin glue and polyglycolic acid felt on prophylaxis of pancreatic fistula following splenectomy.
Scientific Title
Pancreatic fistula following laparoscopic splenectomy: impact of fibrin glue and polyglycolic acid felt on prophylaxis of postoperative complication.
Scientific Title:Acronym
Impact of fibrin glue and polyglycolic acid felt on prophylaxis of pancreatic fistula following splenectomy.
Region
| Japan |
Condition
Condition
Patients who underwent laparoscopic splenectomy
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim was to determine the incidence of pancreatic fistula following laparoscopic splenectomy, and the impact of fibrin glue and polyglycolic acid felt on prophylaxis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the incidence of pancreatic fistula following laparoscopic splenectomy with or without fibrin glue and PGA felt
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients were covered on the staple line with fibrin glue and PGA felt.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent laparoscopic splenectomy
Key exclusion criteria
1. Patients who were converted open surgery
2. Patients who had emergency surgery
3. Patients who were performed non-standardized laparoscopic splenectomy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norifumi Tsutsumi |
Organization
National Hospital Organization, Kyushu Medical Center
Division name
Department of Surgery, Center for Gastroenterology
Zip code
Address
1-8-1 Jigyohama, Chuo-ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
tnori@kyumed.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norifumi Tsutsumi |
Organization
National Hospital Organization, Kyushu Medical Center
Division name
Department of Surgery, Center for Gastroenterology
Zip code
Address
1-8-1 Jigyohama, Chuo-ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
Homepage URL
tnori@kyumed.jp
Sponsor or person
Institute
National Hospital Organization, Kyushu Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2014 | Year | 10 | Month | 23 | 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
Completed
Date of protocol fixation
| 2009 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 22 | Day |
Last modified on
| 2014 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018018
