Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Single incision laparoscopic surgery
Conventional laparoscopic surgery
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Single-incision, Laparoscopy, Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 18 years < age < 80 years
- Tumor located in rectosigmoid (defined as 10- to 30-cm from the anal verge)
- Pathological rectosigmoid carcinoma
- Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual
- Tumor size of 5 cm or less; 6) ECOG score is 0-1
- ASA socre is Ⅰ-Ⅲ
- Informed consent
Exclusion Criteria:
- Body mass index (BMI) >30 kg/m2
- Pregnant woman or lactating woman
- Severe mental disease
- Previous abdominal surgery
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
- Requirement of simultaneous surgery for other disease
Sites / Locations
- Nanfang Hospital, Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Single incision laparoscopic surgery
Conventional laparoscopic surgery
Arm Description
Transumbilical single incision laparoscopic surgery will be performed for patients in this group.And addition of only one trocar through the stoma for drainage tube is allowed.
Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
Outcomes
Primary Outcome Measures
Early morbidity rate
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery,
Secondary Outcome Measures
Operative outcomes
Operative time, estimated blood loss and incision length are recorded.
Pathological outecomes
Tumor size, length of proximal and distal margin and lymph nodes harvested are used to assess oncological resection.
Postoperative recovery course
Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recoverty course.
Pain score
Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge.
Cosmetic assessment
Cosmetic assessment is perform using body image scale and cosmetic scale.
3-year disease free survival rate
5-year overall survival rate
Inflammatory and immune response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02117557
Brief Title
Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Official Title
A Prospective Randomized Controlled Trial Comparing Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guoxin Li
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Compared with traditional open colectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its short- and long-term oncologic outcomes have been demonstrated.
In experienced surgeons' hands, single incision laparoscopic surgery is increasingly performed for colorectal disease, and even for malignant lesion because of its reduced incision-associated morbidity and scarring.
However, the safety and efficacy of single incision laparoscopic surgery for colorectal cancer has not yet been evaluated. Thus, the prospective randomized trial comparing single incision versus conventional laparoscopic surgery for colorectal cancer is needed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Single-incision, Laparoscopy, Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single incision laparoscopic surgery
Arm Type
Experimental
Arm Description
Transumbilical single incision laparoscopic surgery will be performed for patients in this group.And addition of only one trocar through the stoma for drainage tube is allowed.
Arm Title
Conventional laparoscopic surgery
Arm Type
Active Comparator
Arm Description
Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
Intervention Type
Procedure
Intervention Name(s)
Single incision laparoscopic surgery
Other Intervention Name(s)
SILS
Intervention Type
Procedure
Intervention Name(s)
Conventional laparoscopic surgery
Other Intervention Name(s)
CLS
Primary Outcome Measure Information:
Title
Early morbidity rate
Description
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery,
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Operative outcomes
Description
Operative time, estimated blood loss and incision length are recorded.
Time Frame
intraoperative
Title
Pathological outecomes
Description
Tumor size, length of proximal and distal margin and lymph nodes harvested are used to assess oncological resection.
Time Frame
5 days
Title
Postoperative recovery course
Description
Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recoverty course.
Time Frame
14 days
Title
Pain score
Description
Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge.
Time Frame
14 days
Title
Cosmetic assessment
Description
Cosmetic assessment is perform using body image scale and cosmetic scale.
Time Frame
14 days
Title
3-year disease free survival rate
Time Frame
36 months
Title
5-year overall survival rate
Time Frame
60 months
Title
Inflammatory and immune response
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years < age < 80 years
Tumor located in rectosigmoid (defined as 10- to 30-cm from the anal verge)
Pathological rectosigmoid carcinoma
Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual
Tumor size of 5 cm or less; 6) ECOG score is 0-1
ASA socre is Ⅰ-Ⅲ
Informed consent
Exclusion Criteria:
Body mass index (BMI) >30 kg/m2
Pregnant woman or lactating woman
Severe mental disease
Previous abdominal surgery
Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
Requirement of simultaneous surgery for other disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guoxin Li, M.D., PH.D.
Phone
+86-138-0277-1450
Email
gzliguoxin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanan Wang, M.D.
Phone
+86-150-1875-3181
Email
wyn8116@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D., PH.D.
Organizational Affiliation
Nanfang Hospital, Southern Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510-515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D.,PH.D.
Phone
+86-138-0277-1450
Email
gzliguoxin@163.com
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D.,PH.D.
First Name & Middle Initial & Last Name & Degree
Yanan Wang, M.D.
First Name & Middle Initial & Last Name & Degree
Haijun Deng, M.D.,PH.D.
First Name & Middle Initial & Last Name & Degree
Qi Xue, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
19966617
Citation
Bucher P, Pugin F, Morel P. Single-port access laparoscopic radical left colectomy in humans. Dis Colon Rectum. 2009 Oct;52(10):1797-801. doi: 10.1007/DCR.0b013e3181b551ce.
Results Reference
background
PubMed Identifier
20734083
Citation
Gash KJ, Goede AC, Chambers W, Greenslade GL, Dixon AR. Laparoendoscopic single-site surgery is feasible in complex colorectal resections and could enable day case colectomy. Surg Endosc. 2011 Mar;25(3):835-40. doi: 10.1007/s00464-010-1275-8. Epub 2010 Aug 24.
Results Reference
background
PubMed Identifier
22991135
Citation
Lim SW, Kim HJ, Kim CH, Huh JW, Kim YJ, Kim HR. Umbilical incision laparoscopic colectomy with one additional port for colorectal cancer. Tech Coloproctol. 2013 Apr;17(2):193-9. doi: 10.1007/s10151-012-0900-z. Epub 2012 Sep 19.
Results Reference
background
PubMed Identifier
23238505
Citation
Hirano Y, Hattori M, Douden K, Shimizu S, Sato Y, Maeda K, Hashizume Y. Single-incision plus one port laparoscopic anterior resection for rectal cancer as a reduced port surgery. Scand J Surg. 2012;101(4):283-6. doi: 10.1177/145749691210100411.
Results Reference
background
PubMed Identifier
30006846
Citation
Wang Y, Deng H, Mou T, Li J, Liu H, Zhou H, Li G. Short-term outcomes of single-incision plus one-port laparoscopic versus conventional laparoscopic surgery for rectosigmoid cancer: a randomized controlled trial. Surg Endosc. 2019 Mar;33(3):840-848. doi: 10.1007/s00464-018-6350-6. Epub 2018 Jul 13.
Results Reference
derived
PubMed Identifier
26620555
Citation
Wang Y, Liu R, Zhang Z, Xue Q, Yan J, Yu J, Liu H, Zhao L, Mou T, Deng H, Li G. A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial. Trials. 2015 Nov 30;16:539. doi: 10.1186/s13063-015-1067-5.
Results Reference
derived
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Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
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