Total Laparoscopic Versus Laparoscopic Assisted Left-sided Colon Cancer Resection

Study Overview
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Brief Summary
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The comparison between total laparoscopic and laparoscopic assisted left hemicolon cancer resection underwent to choose a more effective and safe operation.

Detailed Description
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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.

Official Title
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Total Laparoscopic Versus Laparoscopic Assisted Left-sided Colon Cancer Resection：A Prospective, Multicenter, Randomized Controlled, Non Inferior Clinical Trial

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: laparoscopic assisted left colectomy
* Procedure: total laparoscopic left colectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopic assisted left colectomy<br>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. | Procedure: laparoscopic assisted left colectomy<br>* 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.<br>|
| Experimental: total laparoscopic left colectomy<br>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. | Procedure: total laparoscopic left colectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the blood loss | the mount of blood loss during the whole operation | one hour after surgery | 
| the operating time | the length between the beginning and the end of the whole operation | one hour after surgery | 
| the incidence of complications |  | one month after surgery | 
| the conversive rate |  | one hour after surgery | 
| Surgical resection quality | according to the CME (complete mesocolic excision,CME) evaluation criteria | one hour after surgery | 
| number of lymphnodes dissected |  | one week after surgery | 
| first defecation time |  | one week after surgery | 
| the incision length |  | one week after surgery | 
| 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) | one day after surgery | 
| 3-year DFS (Disease-free survival) |  | three years after the operation | 
| 5-year OS (overall survival) |  | five years after the operation | 
| first time for fluid diet |  | one week after surgery | 
| hospital stay |  | one month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total laparoscopic, laparoscopic assisted