Total Laparoscopic Versus Laparoscopic Assisted Left-sided Colon Cancer Resection

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

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

Study Overview

• Status: Recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Procedure: laparoscopic assisted left colectomy; Procedure: total laparoscopic left colectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 354
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong Yang, doctor

Study Locations

• China
  • Ji Lin
    • Changchun, Ji Lin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Quan Wang, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: laparoscopic assisted left colectomy; 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; 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.
Experimental: total laparoscopic left colectomy; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Anticipated): December 20, 2021
• Study Completion (Anticipated): December 20, 2026

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 14, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 20, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: total laparoscopic; laparoscopic assisted
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 130023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No