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The risk factor of postoperative anal pain after laparoscopic low rectal resection surgery

Status Approved

First Submitted Date

2015/01/14
Registered Date

2015/01/27
Last Updated Date

2015/01/27

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
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

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
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
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
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

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
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
Name of Study	Samsung Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2015-01-08 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Samsung Medical Center
Organization Type	Medical Institute
Project ID	IRB 2014-12-067

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Samsung Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
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 Summary Information

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.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Retrospective
Target Number of Participant	500
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Rectal cancer patients who underwent laparoscopic low anterior resection at Samsung Medical Center
Cohort/ Group 1	Cohort/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

9. Subject Eligibility

Subject Eligibility Information
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)	* (C00-D48)Neoplasms (C20)Malignant neoplasm of rectum
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

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
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

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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