Back to resultsTotal Laparoscopic Versus Laparoscopic Assisted Left-sided Colon Cancer Resection
Primary Purpose
Colon Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic assisted left colectomy
total laparoscopic left colectomy
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer focused on measuring total laparoscopic, laparoscopic assisted
Eligibility Criteria
Inclusion Criteria:
- left sided cancer was defined as a tumour located in the distal third of transverse colon, in the left colonic angle, in the proximal descending colon, or the upper sigmoid colon（cT1-cT4a）.
- underwent total laparoscopic or laparoscopic assisted left-sided cancer resection
Exclusion Criteria:
have simultaneously other cancer
- have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
- the period is too late or the tumor is too large to carry on a total laparoscopic or laparoscopic assisted left-sided cancer resection
Sites / Locations
- the First Hospital of Jilin UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
laparoscopic assisted left colectomy
total laparoscopic left colectomy
Arm Description
All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. The patients in the control group underwent with the traditional laparoscopic assisted technology. The free colon was taken out through a small incision in the middle of the abdomen or the outer edge of the left rectus abdominis. The mesentery was trimmed, the specimens were removed, and the anastomosis was completed.After the anastomosis, the whole surgical area was flushed and drainage tubes were left.
All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion.In the experimental group, the mesentery was endoscopically trimmed, the specimens were excised and the anastomosis was completed under the laparoscope. The specimens were taken out through trocar incision in the navel or in the right lower abdomen. After the anastomosis, the whole surgical area was flushed and drainage tubes were left.
Outcomes
Primary Outcome Measures
surgical site infection，SSI
The primary outcome was the incidence of SSI based on the definitions of CDC guidelines: superficial incisional, deep incisional, and organ/space infections . Infections involving both organ/space and the incisional site (superficial or deep) were categorized as organ/space infections. Surgeons and nurses assessed the presence of infection daily during hospitalization. After hospital discharge, all patients were followed up until 30 days after surgery at outpatient clinics to check the wound.
Secondary Outcome Measures
the blood loss
the mount of blood loss during the whole operation
the operating time
the length between the beginning and the end of the whole operation
the incidence of complications
the conversive rate
Surgical resection quality
according to the CME (complete mesocolic excision,CME) evaluation criteria
number of lymphnodes dissected
first defecation time
the incision length
Visual Analogue Scale/Score (VAS)
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain ( from 0 to 10)
3-year DFS (Disease-free survival)
5-year OS (overall survival)
first time for fluid diet
hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04201717
Brief Title
Total Laparoscopic Versus Laparoscopic Assisted Left-sided Colon Cancer Resection
Official Title
Total Laparoscopic Versus Laparoscopic Assisted Left-sided Colon Cancer Resection：A Prospective, Multicenter, Randomized Controlled, Non Inferior Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
December 20, 2021 (Anticipated)
Study Completion Date
December 20, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jilin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The comparison between total laparoscopic and laparoscopic assisted left hemicolon cancer resection underwent to choose a more effective and safe operation.
Detailed Description
This is a prospective randomized controlled trial. It is estimated that the recruitment time is 24 months and the number of cases is 354 in total. The cases in the experimental group and the control group are allocated according to the proportion of 1:1. The perioperative recovery data, complications and oncology index of total laparoscopic and laparoscopic assisted operation would be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
total laparoscopic, laparoscopic assisted
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
354 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
laparoscopic assisted left colectomy
Arm Type
Active Comparator
Arm Description
All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. The patients in the control group underwent with the traditional laparoscopic assisted technology. The free colon was taken out through a small incision in the middle of the abdomen or the outer edge of the left rectus abdominis. The mesentery was trimmed, the specimens were removed, and the anastomosis was completed.After the anastomosis, the whole surgical area was flushed and drainage tubes were left.
Arm Title
total laparoscopic left colectomy
Arm Type
Experimental
Arm Description
All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion.In the experimental group, the mesentery was endoscopically trimmed, the specimens were excised and the anastomosis was completed under the laparoscope. The specimens were taken out through trocar incision in the navel or in the right lower abdomen. After the anastomosis, the whole surgical area was flushed and drainage tubes were left.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic assisted left colectomy
Intervention Description
All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. The patients in the control group underwent with the traditional laparoscopic assisted technology. The free colon was taken out through a small incision in the middle of the abdomen or the outer edge of the left rectus abdominis. The mesentery was trimmed, the specimens were removed, and the anastomosis was completed. After the anastomosis, the whole surgical area was flushed and drainage tubes were left.
Intervention Type
Procedure
Intervention Name(s)
total laparoscopic left colectomy
Intervention Description
All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. In the experimental group, the mesentery was endoscopically trimmed, the specimens were excised and the anastomosis was completed under the laparoscope. The specimens were taken out through trocar incision in the navel or in the right lower abdomen. After the anastomosis, all surgical area was flushed and drainage tubes were left.
Primary Outcome Measure Information:
Title
surgical site infection，SSI
Description
The primary outcome was the incidence of SSI based on the definitions of CDC guidelines: superficial incisional, deep incisional, and organ/space infections . Infections involving both organ/space and the incisional site (superficial or deep) were categorized as organ/space infections. Surgeons and nurses assessed the presence of infection daily during hospitalization. After hospital discharge, all patients were followed up until 30 days after surgery at outpatient clinics to check the wound.
Time Frame
one month after surgery
Secondary Outcome Measure Information:
Title
the blood loss
Description
the mount of blood loss during the whole operation
Time Frame
one hour after surgery
Title
the operating time
Description
the length between the beginning and the end of the whole operation
Time Frame
one hour after surgery
Title
the incidence of complications
Time Frame
one month after surgery
Title
the conversive rate
Time Frame
one hour after surgery
Title
Surgical resection quality
Description
according to the CME (complete mesocolic excision,CME) evaluation criteria
Time Frame
one hour after surgery
Title
number of lymphnodes dissected
Time Frame
one week after surgery
Title
first defecation time
Time Frame
one week after surgery
Title
the incision length
Time Frame
one week after surgery
Title
Visual Analogue Scale/Score (VAS)
Description
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain ( from 0 to 10)
Time Frame
one day after surgery
Title
3-year DFS (Disease-free survival)
Time Frame
three years after the operation
Title
5-year OS (overall survival)
Time Frame
five years after the operation
Title
first time for fluid diet
Time Frame
one week after surgery
Title
hospital stay
Time Frame
one month after surgery
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:
left sided cancer was defined as a tumour located in the distal third of transverse colon, in the left colonic angle, in the proximal descending colon, or the upper sigmoid colon（cT1-cT4a）.
underwent total laparoscopic or laparoscopic assisted left-sided cancer resection
Exclusion Criteria:
have simultaneously other cancer
have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
the period is too late or the tumor is too large to carry on a total laparoscopic or laparoscopic assisted left-sided cancer resection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quan Wang, professor
Phone
18844097668
Email
18844097668@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Yang, doctor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quan Wang, doctor
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Study Director
Facility Information:
Facility Name
the First Hospital of Jilin University
City
Changchun
State/Province
Ji Lin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quan Wang, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Total Laparoscopic Versus Laparoscopic Assisted Left-sided Colon Cancer Resection
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