Total Laparoscopic Versus Laparoscopic Assisted Left-sided Colon Cancer Resection

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04201717
• Other study ID #: 130023
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2020
• Est. completion date: December 20, 2026

Study information

• Verified date: September 2020
• Source: Jilin University
• Contact: Quan Wang, professor
• Phone: 18844097668
• Email: 18844097668[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: December 20, 2026
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	the First Hospital of Jilin University	Changchun	Ji Lin

Sponsors (1)

Lead Sponsor	Collaborator
Jilin University

Country where clinical trial is conducted

China, 

Outcome

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