Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Single Incision Laparoscopic Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, laparoscopic surgery
Eligibility Criteria
Inclusion Criteria:
- Patients should sign a written informed consent
- Age between 18-80
- Patients have sigmoid colon cancer that was proved by pathology
- Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
- Adequate kidney function Creatinine ≤ 1.5 mg/dl
- No remarkable evidence of heart dysfunction and lung dysfunction
Exclusion Criteria:
- Distant metastasis
- Tumor diameter > 5 cm
- Other organ invasion
- Intestinal obstruction and stent insertion status
- Patient was used steroid
- Patients undergo emergency surgery with multiple symptoms
- Other organ cancer history (except who had radical excision for skin cancer)
- Presence of other serious disease
- Mentally ill patients
- Legally unable to participate in clinical trial
- Lactating or pregnant women
- Patients who will obviously fail to regular follow-up visit or will be off study voluntarily
- Not eligible to participate for other reasons by doctor's decision
Sites / Locations
- National Cancer Center Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single incision sigmoidectomy
Arm Description
Single incision laparoscopic sigmoidectomy for sigmoid colon cancer
Outcomes
Primary Outcome Measures
Harvested numbers of lymph node
Secondary Outcome Measures
Postoperative mortality, morbidity
Full Information
NCT ID
NCT01269060
First Posted
January 3, 2011
Last Updated
August 2, 2012
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT01269060
Brief Title
Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery
Official Title
Phase 2 Study of Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single incision (Embryonic NOTES) colon surgery has been attempted.
However, there are not sufficient evidences for single incision colon surgery in colon cancer.
The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer.
Detailed Description
After several randomized clinical trials, laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single Incision (Embryonic NOTES) colon surgery has been attempted. Several studies reported the feasibility of single incision colon surgery.However, there are not sufficient evidences for single incision colon surgery, especially in colon cancer.
The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer. Harvested numbers of lymph node will be assessed for the efficacy and postoperative morbidity and mortality will be assess for the safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer, laparoscopic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single incision sigmoidectomy
Arm Type
Experimental
Arm Description
Single incision laparoscopic sigmoidectomy for sigmoid colon cancer
Intervention Type
Procedure
Intervention Name(s)
Single Incision Laparoscopic Surgery
Other Intervention Name(s)
Embryonic NOTES Sigmoidectomy
Intervention Description
Single Incision Laparoscopic Sigmoidectomy
Primary Outcome Measure Information:
Title
Harvested numbers of lymph node
Time Frame
Within the first 7 days (plus or minus 3 days) after surgery
Secondary Outcome Measure Information:
Title
Postoperative mortality, morbidity
Time Frame
Within 30 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients should sign a written informed consent
Age between 18-80
Patients have sigmoid colon cancer that was proved by pathology
Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
Adequate kidney function Creatinine ≤ 1.5 mg/dl
No remarkable evidence of heart dysfunction and lung dysfunction
Exclusion Criteria:
Distant metastasis
Tumor diameter > 5 cm
Other organ invasion
Intestinal obstruction and stent insertion status
Patient was used steroid
Patients undergo emergency surgery with multiple symptoms
Other organ cancer history (except who had radical excision for skin cancer)
Presence of other serious disease
Mentally ill patients
Legally unable to participate in clinical trial
Lactating or pregnant women
Patients who will obviously fail to regular follow-up visit or will be off study voluntarily
Not eligible to participate for other reasons by doctor's decision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Hwan Oh, Dr. PhD.
Organizational Affiliation
Center for Colorectal Cancer, National Cancer Center Korea
Official's Role
Study Chair
Facility Information:
Facility Name
National Cancer Center Hospital
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery
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