Resection Margin of Transverse Colon Cancer With Extracorporeal Versus Intracorporeal Anastomosis

March 5, 2024 updated by: Shanghai Minimally Invasive Surgery Center

The Impact of Intracorporeal Anastomosis on Resection Margin During Laparoscopic Radical Resection of Transverse Colon Cancer: a Retrospective Multi-center Study

The approach of anastomosis in laparoscopic resection of transverse colon cancer (TCC) has rarely been discussed. This study aims to compare the resection margin of TCC with extracorporeal anastomosis (ECA) versus intracorporeal anastomosis (ICA).

Patients who underwent laparoscopic resection of TCC from August 2019 to July 2021 in 13 participating centers are included in this study. According to the approach of anastomosis, patients are divided into two groups, ECA group and ICA group respectively. The clinical characteristics, the perioperative outcomes and the pathological results (especially the length of resection margin) are compared between the two groups. The length of two-sided resection margins (long margin, short margin) are measured on formalin-fixed specimens and those with short margin less than 4.0 cm are defined as unqualified specimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

13 participating centers are as follows: Ruijin Hospital, Shanghai Jiaotong University School of Medicine；Zhejiang University Medical College Affiliated Sir Run Shaw Hospital；Zhongshan Hospital Affiliated to Fudan University；Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University; Jiangsu Provincial People's Hospital; Xiangya Hospital of Central South University; The First Affiliated Hospital of Chongqing Medical University; The first hospital of Jilin University; Beijing Friendship Hospital Affiliated to Capital Medical University; Tangdu Hospital; Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology; Cancer Hospital of Chinese Academy of Medical Sciences; Henan Provincial People's Hospital

Study Type

Observational

Enrollment (Actual)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Minimally Invasive Surgery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

transverse colon cancer

Description

Inclusion Criteria:

  • 1. pathologically confirmed adenocarcinoma of colon
  • 2. The tumor is located in the transverse colon (including hepatic or splenic flexure);
  • 3. One of the following procedures was performed: transverse colectomy, right hemicolectomy, enlarged right hemicolectomy, left colectomy, enlarged left colectomy;
  • 4. Laparoscopic surgery (laparoscopy-assisted surgery or complete laparoscopic surgery) from August 2019 to July 2021;
  • 5. Radical resection (R0) was accomplished;

Exclusion Criteria:

  • 1. Simultaneous multiple colorectal cancer;
  • 2. history of colorectal surgery (except endoscopic surgery);
  • 3. robot-assisted surgery;
  • 4. palliative resection (non-R0 resection) or palliative bypass;
  • 5. the approach of anastomosis could not be determined from the documents;
  • 6. the length of resection margin was not recorded in pathological report;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ECA group
TCC with extracorporeal anastomosis (ECA)
Procedure: approach of anastomosis
The approach of anastomosis
ICA group
TCC with intracorporeal anastomosis (ICA).
Procedure: approach of anastomosis
The approach of anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of the resection margin
Time Frame: one month after surgery
length of the two -sided resection margins measured on formalin-fixed specimen (CM)
one month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Minimally Invasive Surgery Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

September 18, 2021

First Submitted That Met QC Criteria

September 18, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISC-TCC-ECA-ICA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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