UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014199 |
|---|---|
| Receipt number | 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 22:21:29 |
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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 | Obstetrics 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
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
marcoscioscia@gmail.com
Sponsor or person
Institute
No sponsor required
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016532
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
