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Safety and Efficacy of Long Limb Roux-en Y Reconstruction (LoLiRoRe)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seung Ho Choi, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT01373346
First received: June 13, 2011
Last updated: August 30, 2012
Last verified: August 2012
Results First Received: March 11, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes Mellitus Type 2 in Nonobese
Gastric Cancer
Intervention: Procedure: Long limb Roux-en Y reconstruction

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
If Patients were eligible for the study, each patient was informed of the investigational nature of the trial and received detailed information regarding the study protocol. All patients provided written informed consent before their enrollment. The enrollment continued from February 2010 through May 2011 in Gangnam Severance Hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Long Limb Roux-en Y Reconstruction Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction

Participant Flow:   Overall Study
    Long Limb Roux-en Y Reconstruction  
STARTED     15  
COMPLETED     14  
NOT COMPLETED     1  
Death                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Long Limb Roux-en Y Reconstruction Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction

Baseline Measures
    Long Limb Roux-en Y Reconstruction  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation
  62.1  ± 8.7  
Gender  
[units: participants]
 
Female     5  
Male     10  
Region of Enrollment  
[units: participants]
 
Korea, Republic of     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Morbidity   [ Time Frame: Until end of study (on average 14.8 months) ]

2.  Primary:   HbA1c   [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ]

3.  Primary:   Hemoglobin   [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ]

4.  Primary:   Albumin   [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ]

5.  Primary:   Operation Related Mortality   [ Time Frame: Until end of study (on average 14.8 months) ]

6.  Secondary:   Matsuda Index   [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ]

7.  Secondary:   QUICKI   [ Time Frame: Before operation , 6 months after operation , Until end of study (on average 14.8 months) ]

8.  Secondary:   HOMA-IR   [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ]

9.  Secondary:   HOMA-B   [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ]

10.  Secondary:   Body Mass Index   [ Time Frame: Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months) ]

11.  Secondary:   Matsuda Index : Good Response Group   [ Time Frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months) ]

12.  Secondary:   QUICKI : Good Response Group   [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ]

13.  Secondary:   HOMA-IR : Good Response Group   [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ]

14.  Secondary:   HOMA-B : Good Response Group   [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ]

15.  Secondary:   Body Mass Index : Good Response Group   [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ]

16.  Secondary:   HbA1c : Good Response Group   [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ]

17.  Secondary:   Hemoglobin : Good Response Group   [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ]

18.  Secondary:   Albumin : Good Response Group   [ Time Frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
One mortality due to early recurrence leading to reduced number of subject analyzed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Seung Ho Choi, M.D., Ph.D.
Organization: Gangnam severance hospital
phone: 82-2-2019-3374
e-mail: choish@yuhs.ac


Publications:


Responsible Party: Seung Ho Choi, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT01373346     History of Changes
Other Study ID Numbers: seungho-1
Study First Received: June 13, 2011
Results First Received: March 11, 2012
Last Updated: August 30, 2012
Health Authority: Korea: Institutional Review Board