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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014199
Receipt No. R000016532
Scientific Title Clinical feasibility and cost analysis of a fast track protocol for laparoscopic colorectal surgery for deep infiltrating endometriosis
Date of disclosure of the study information 2014/06/07
Last modified on 2014/06/06

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Basic information
Public title Clinical feasibility and cost analysis of a fast track protocol for laparoscopic colorectal surgery for deep infiltrating endometriosis
Acronym Fast track in colorectal surgery for endometriosis
Scientific Title Clinical feasibility and cost analysis of a fast track protocol for laparoscopic colorectal surgery for deep infiltrating endometriosis
Scientific Title:Acronym Fast track in colorectal surgery for endometriosis
Region
Europe

Condition
Condition Application of a fast track protocol for elective colorectal surgery for endometriosis
Classification by specialty
Gastrointestinal surgery Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Colorectal surgery for deep infiltrating endometriosis is required often to ameliorate symtoms in severe endometriosis that involves the bowel. This kind of surgery requires specific laparoscopic skills and usually is carried out in referral centers. The safety of the procedure is strictly linked to the experience of operators. Colorectal surgery represents a vast part of high costs for endometriosis when medical treatment fails.
This study was to address the efficacy and safety of the application of fast track protocols in such cases.
Basic objectives2 Others
Basic objectives -Others Cost analysis
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Safety of the protocol evaluated on clinical outcomes at medium term.
Key secondary outcomes Cost analysis

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 No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Application of a fast track protocol for colorectal surgery
Interventions/Control_2 Application of a classical protocol for colorectal 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
18 years-old <
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria - Bowel endometriosis
- Laparoscopic surgical approach
Key exclusion criteria - Laparotomic surgical approach
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Giacomo Ruffo
Organization Sacro Cuore Don Calabria General Hospital
Division name General Surgery
Zip code
Address via Sempreboni 5, 37024 Negrar (VR), Italy
TEL +81-0390456013111
Email marco.scioscia@sacrocuore.it

Public contact
Name of contact person
1st name
Middle name
Last name Marco Scioscia
Organization Sacro Cuore Don Calabria General Hospital
Division name Obstetrics and Gynecology
Zip code
Address via Sempreboni 5, 37024 Negrar (VR), Italy
TEL +81-0393498724206
Homepage URL
Email marcoscioscia@gmail.com

Sponsor
Institute No sponsor required
Institute
Department

Funding Source
Organization No Funding
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
2014 Year 06 Month 07 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 Terminated
Date of protocol fixation
2012 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 01 Month 10 Day
Date analysis concluded
2014 Year 05 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 06 Day
Last modified on
2014 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016532

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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