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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2015/01/14
    • Registered Date : 2015/01/27
    • Last Updated Date : 2015/01/27
Background Information
1.Background  
CRIS Registration Number KCT0001359 
Unique Protocol ID IRB 2014-12-067 
Public/Brief Title The risk factor of postoperative anal pain after laparoscopic low rectal resection surgery 
Scientific Title The risk factor of postoperative anal pain after laparoscopic low rectal resection surgery  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
 
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number SMC 2014-12-067-001 
Approval Date 2015-01-07 
Institutional Review Board  
- Name Samsung Medical Center Institutional Review Board  
- Address  
- Telephone  
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Woo Seog Sim 
- Title MD, Ph D 
- Telephone  
- Affiliation Samsung Medical Center  
- Address  
Contact Person for Public Queries
- Name Jin Young Lee 
- Title MD, Ph D 
- Telephone  
- Affiliation Samsung Medical Center  
- Address  
Contact Person for Updating Information
- Name Jin Young Lee 
- Title MD, Ph D 
- Telephone  
- Affiliation Samsung Medical Center  
- Address  
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Recruiting  
Date of First Enrollment 2015-01-08 , Actual
Target Number of Participant 500
Primary Completion Date 2015-12-31 , Anticipated
Study Completion Date 2015-12-31 , Anticipated
Recruitment Status by Participating Study Site 1 
- Name of Study Site Samsung Medical Center  
- Recruitment Status Recruiting  
- Date of First Enrollment 2015-01-08 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Samsung Medical Center  
- Organization Type Medical Institute  
- Project ID IRB 2014-12-067 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Samsung Medical Center  
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
Lay Summary Despite recent advances in rectal cancer surgical techniques and perioperative management, postoperative anal pain poses one of the discomforts and continues to be a clinical problem. The aim of this study was to identify risk factors for postoperative anal pain after laparoscopic low anterior resection.  
Study Design 정보
8. Study Design  
Study Type Observational Study 
Observational Study Model Cohort 
Time Perspective Retrospective  
Target Number of Participant 500
Cohort/Group Number
Cohort/
Group 1
Cohort/
Group Label
Rectal cancer patients who underwent laparoscopic low anterior resection at Samsung Medical Center 
Group Description Patients is divided into 2 groups, patients with postoperative anal pain and patients without postoperative anal pain. The perioperative data will be examined by univariate and multivariate analysis 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Subject Eligibility Information
9. Subject  
Study Population Description Rectal cancer patients who underwent laparoscopic low anterior resection at Samsung Medical Center  
Sampling Method The data of rectal cancer patients who underwent laparoscopic low anterior resection at Samsung Medical Center between June 2013 and August 2014  
Condition(s)/Problem(s) * Diseases of the digestive system
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age No Limit ~ No Limit
Description Rectal cancer patients who underwent laparoscopic low anterior resection at Samsung Medical Center  
Exclusion Criteria Patients who are not indicated for this study  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Not applicable 
Primary Outcome(s) 1 
- Outcome Ileostomy 
- Timepoint End of surgery 
Primary Outcome(s) 2 
- Outcome anastomosis magin from anal verge 
- Timepoint End of surgery 
Primary Outcome(s) 3 
- Outcome post-op pain 
- Timepoint posto-op 1,3,5 day, post-op outpatient clinic 
Secondary Outcome(s) 1 
- Outcome pre-op concurrent chemo-radiotherapy, Presence of underlying disease 
- Timepoint before anesthesia 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Not provided at time of Registration