Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04201717
Other study ID # 130023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT03457454 - Reducing Rural Colon Cancer Disparities
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Terminated NCT01347645 - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer Phase 1/Phase 2
Completed NCT03390907 - Hybrid APC Assisted EMR for Large Colon Polyps N/A
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT04079478 - The AID Study: Artificial Intelligence for Colorectal Adenoma Detection
Active, not recruiting NCT04057274 - Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth N/A
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Not yet recruiting NCT05147545 - Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects N/A
Recruiting NCT05026268 - The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis N/A
Not yet recruiting NCT03277235 - Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients N/A
Active, not recruiting NCT02959541 - PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer N/A
Active, not recruiting NCT02730702 - Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Recruiting NCT02526836 - Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer Phase 2/Phase 3