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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003711
Receipt No. 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

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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
Email 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
Email skomat@nagoya2.jrc.or.jp

Sponsor
Institute Nagoya Daini Red Cross Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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