UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003711 |
|---|---|
| Receipt number | R000004493 |
| Scientific Title | Value of laparoscopic appendectomy in perforated appendicitis -A randomized controlled trial- |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2015/08/18 15:19:46 |
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Basic information
Public title
Value of laparoscopic appendectomy in perforated appendicitis -A randomized controlled trial-
Acronym
Value of laparoscopic appendectomy in perforated appendicitis
Scientific Title
Value of laparoscopic appendectomy in perforated appendicitis -A randomized controlled trial-
Scientific Title:Acronym
Value of laparoscopic appendectomy in perforated appendicitis
Region
| Japan |
Condition
Condition
Complicated appendicitis, diagnosed as having peritonitis or abscess formation.
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and assess the rate of postoperative infectious complications between the randomized groups of laparoscopic and open surgery, in patients with perforated appendicitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of postoperative infectious complications
Key secondary outcomes
Rate of reoperation
Indices of postoperative recovery (analgesic use, oral intake restart, physical activity, bowel movement)
Duration of hospital stay
Operating time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Laparoscopic surgery
Interventions/Control_2
Open surgery
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as having complicated appendicitis with peritonitis or abscess formation, by abdominal examination, laboratory data, or CT
Key exclusion criteria
Cases having other diseases, such as colon cancer or inflammatory bowel disease.
In case significant changes are needed in the planning of surgery (e.g. addition of colon resection).
In case laparoscopic approach appears not to be appropriate, because of previous abdominal surgery or remarkable distension of the intestine.
Instability of respiration or circulation due to systemic infectious complications.
Those who cannot understand the concept of the study (e.g. dementia or mental disorders).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichiro Komatsu |
Organization
Nagoya Daini Red Cross Hospital
Division name
Surgery
Zip code
Address
2-9, Myokencho, Showaku, Nagoya City, Aichi Pref.
TEL
052-832-1121
skomat@nagoya2.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunichiro Komatsu |
Organization
Nagoya Daini Red Cross Hospital
Division name
Surgery
Zip code
Address
2-9, Myokencho, Showaku, Nagoya City, Aichi Pref.
TEL
052-832-1121
Homepage URL
skomat@nagoya2.jrc.or.jp
Sponsor or person
Institute
Nagoya Daini Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya Daini Red Cross 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
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
| 2010 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s00464-015-4453-x
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
| 2008 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 04 | Day |
Last modified on
| 2015 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004493
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
